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DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
3
**
**
A
**
3M
* 3M CO
PERIDEX, CHLORHEXIDINE GLUCONATE
* 3M HEALTH CARE INC
AVAGARD, ALCOHOL
(OTC)
DURAPREP, IODINE POVACRYLEX
(OTC)
* 3M PHARMACEUTICALS INC
PROVENTIL-HFA, ALBUTEROL SULFATE
AAIPHARMA LLC
* AAIPHARMA LLC
AZASAN, AZATHIOPRINE
ABBOTT
* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
HYTRIN, TERAZOSIN HYDROCHLORIDE
ABBVIE
* ABBVIE INC
ANDROGEL, TESTOSTERONE
CREON, PANCRELIPASE (AMYLASE
CYCLOSPORINE, CYCLOSPORINE
K-TAB, POTASSIUM CHLORIDE
NIASPAN, NIACIN
TRILIPIX, CHOLINE FENOFIBRATE
ZEMPLAR, PARICALCITOL
ABBVIE ENDOCRINE
* ABBVIE ENDOCRINE INC
LUPANETA PACK, LEUPROLIDE ACETATE
ABBVIE ENDOCRINE INC
* ABBVIE ENDOCRINE INC
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
ABBVIE INC
* ABBVIE INC
PROMETRIUM, PROGESTERONE
ABRAXIS BIOSCIENCE
* ABRAXIS BIOSCIENCE LLC
ABRAXANE, PACLITAXEL
ABRAXIS PHARM
* ABRAXIS PHARMACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
ACADEMIC PHARMS
* ACADEMIC PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
ACCELRX LABS
* ACCELRX LABS LLC
CARISOPRODOL, CARISOPRODOL
ACCORD HLTHCARE
* ACCORD HEALTHCARE INC
ALLOPURINOL, ALLOPURINOL
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DOCETAXEL, DOCETAXEL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ETOPOSIDE, ETOPOSIDE
FINASTERIDE, FINASTERIDE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
B - 1
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 2
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ACCORD HEALTHCARE INC
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL, LISINOPRIL
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHYLDOPA, METHYLDOPA
MITOMYCIN, MITOMYCIN
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
SIMVASTATIN, SIMVASTATIN
TACROLIMUS, TACROLIMUS
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
ACCORD HLTHCARE INC
* ACCORD HEALTHCARE INC USA
FINASTERIDE, FINASTERIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ACELLA PHARMS LLC
* ACELLA PHARMACEUTICALS LLC
GABAPENTIN, GABAPENTIN
ACORDA
* ACORDA THERAPEUTICS INC
AMPYRA, DALFAMPRIDINE
QUTENZA, CAPSAICIN
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ACS DOBFAR
* ACS DOBFAR SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOXITIN, CEFOXITIN SODIUM
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
KEFZOL, CEFAZOLIN SODIUM
MEROPENEM, MEROPENEM
ACS DOBFAR INFO SA
* ACS DOBFAR INFO SA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACS DOBFAR SPA
* ACS DOBFAR SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
ACTAVIS
* ACTAVIS SOUTHATLANTIC LLC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
ACTAVIS ELIZABETH
* ACTAVIS ELIZABETH LLC
ALPRAZOLAM, ALPRAZOLAM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ACTAVIS ELIZABETH LLC
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GABAPENTIN, GABAPENTIN
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOVASTATIN, LOVASTATIN
MORPHINE SULFATE, MORPHINE SULFATE
NIFEDIPINE, NIFEDIPINE
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
TEMAZEPAM, TEMAZEPAM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS GRP PTC
* ACTAVIS GROUP PTC EHF
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ACTAVIS INC
* ACTAVIS INC
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOCETAXEL, DOCETAXEL
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACTAVIS MID ATLANTIC
* ACTAVIS MID ATLANTIC LLC
ACETASOL HC, ACETIC ACID, GLACIAL
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
(OTC)
CONSTULOSE, LACTULOSE
ENULOSE, LACTULOSE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FLUOCINONIDE, FLUOCINONIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCORTISONE, HYDROCORTISONE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
LEVETIRACETAM, LEVETIRACETAM
M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MICONAZOLE 7, MICONAZOLE NITRATE
(OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE
(OTC)
MINOXIDIL (FOR MEN), MINOXIDIL
(OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL
(OTC)
NYSTATIN, NYSTATIN
B - 3
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ACTAVIS MID ATLANTIC LLC
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN
(OTC)
PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
VALNAC, BETAMETHASONE VALERATE
ACTAVIS TOTOWA
* ACTAVIS TOTOWA LLC
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LETROZOLE, LETROZOLE
OXALIPLATIN, OXALIPLATIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PACLITAXEL, PACLITAXEL
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ACTELION PHARMS LTD
* ACTELION PHARMACEUTICALS LTD
OPSUMIT, MACITENTAN
TRACLEER, BOSENTAN
VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE
VELETRI, EPOPROSTENOL SODIUM
VENTAVIS, ILOPROST
ZAVESCA, MIGLUSTAT
ACTIENT PHARMS
* ACTIENT PHARMACEUTICALS LLC
DILATRATE-SR, ISOSORBIDE DINITRATE
EDEX, ALPROSTADIL
LEVATOL, PENBUTOLOL SULFATE
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
SEMPREX-D, ACRIVASTINE
STRIANT, TESTOSTERONE
TESTOPEL, TESTOSTERONE
THEO-24, THEOPHYLLINE
ACTIVIS TOTOWA LLC
* ACTIVIS TOTOWA LLC
TOPIRAMATE, TOPIRAMATE
ACTON PHARMS
* ACTON PHARMACEUTICALS INC
AEROSPAN HFA, FLUNISOLIDE
AEGERION
* AEGERION PHARMACEUTICALS INC
JUXTAPID, LOMITAPIDE MESYLATE
AGILA SPECLTS
* AGILA SPECIALTIES PRIVATE LTD
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLUMAZENIL, FLUMAZENIL
HALOPERIDOL, HALOPERIDOL LACTATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
B - 4
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 5
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AGILA SPECIALTIES PRIVATE LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
RIFAMPIN, RIFAMPIN
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
AGOURON
* AGOURON PHARMACEUTICALS INC
VIRACEPT, NELFINAVIR MESYLATE
AJANTA PHARMA
* AJANTA PHARMA LTD
LEVETIRACETAM, LEVETIRACETAM
AJANTA PHARMA LTD
* AJANTA PHARMA LTD
RISPERIDONE, RISPERIDONE
AKORN
* AKORN INC
ADENOSINE, ADENOSINE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKTEN, LIDOCAINE HYDROCHLORIDE
ALFENTA, ALFENTANIL HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BACITRACIN, BACITRACIN
BALANCED SALT, CALCIUM CHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CALCITRIOL, CALCITRIOL
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN
DICLOFENAC SODIUM, DICLOFENAC SODIUM
ENDOSOL EXTRA, CALCIUM CHLORIDE
ERYTHROMYCIN, ERYTHROMYCIN
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IC-GREEN, INDOCYANINE GREEN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE
(OTC)
LATANOPROST, LATANOPROST
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
NEDOCROMIL SODIUM, NEDOCROMIL SODIUM
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TROPICACYL, TROPICAMIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
AKORN INC
* AKORN INC
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 6
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE
(OTC)
NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
AKRIMAX PHARMS
* AKRIMAX PHARMACEUTICALS LLC
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
ALARA PHARM
* ALARA PHARMACEUTICAL CORPORATION
LEVO-T, LEVOTHYROXINE SODIUM **
ALCON
* ALCON INC
TRIESENCE, TRIAMCINOLONE ACETONIDE
* ALCON LABORATORIES INC
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
CETAMIDE, SULFACETAMIDE SODIUM
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
MIOSTAT, CARBACHOL
OMNIPRED, PREDNISOLONE ACETATE
ALCON LABS INC
* ALCON LABORATORIES INC
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
ALCON PHARMA
* ALCON RESEARCH LTD
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
ZADITOR, KETOTIFEN FUMARATE
(OTC)
ALCON PHARMS LTD
* ALCON PHARMACEUTICALS LTD
DUREZOL, DIFLUPREDNATE
MOXEZA, MOXIFLOXACIN HYDROCHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
QOLIANA, BRIMONIDINE TARTRATE
TRIFLURIDINE, TRIFLURIDINE
ALCON RES
* ALCON RESEARCH LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE
LATANOPROST, LATANOPROST
ALCON RES LTD
* ALCON RESEARCH LTD
ILEVRO, NEPAFENAC
SIMBRINZA, BRIMONIDINE TARTRATE
ALEMBIC LTD
* ALEMBIC LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
METRONIDAZOLE, METRONIDAZOLE
MODAFINIL, MODAFINIL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ALEMBIC PHARMS LTD
* ALEMBIC PHARMACEUTICALS LTD
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ALEMBIC PHARMACEUTICALS LTD
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DESVENLAFAXINE, DESVENLAFAXINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LAMOTRIGINE, LAMOTRIGINE
LEFLUNOMIDE, LEFLUNOMIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEPROBAMATE, MEPROBAMATE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ALKEM
* ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
GABAPENTIN, GABAPENTIN
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ALKEM LABS LTD
* ALKEM LABORATORIES LTD
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
ALKERMES
* ALKERMES INC
VIVITROL, NALTREXONE
ALKERMES GAINESVILLE
* ALKERMES GAINESVILLE LLC
VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERELAN, VERAPAMIL HYDROCHLORIDE
ALKOPHARMA USA
* ALKOPHARMA USA INC
AMPHOTEC, AMPHOTERICIN B
ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMINE
ALPHAGAN P, BRIMONIDINE TARTRATE
BLEPH-10, SULFACETAMIDE SODIUM
ZYMAXID, GATIFLOXACIN
* ALLERGAN INC
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACZONE, DAPSONE
ALBALON, NAPHAZOLINE HYDROCHLORIDE
ALOCRIL, NEDOCROMIL SODIUM
ALPHAGAN P, BRIMONIDINE TARTRATE
AVAGE, TAZAROTENE
COMBIGAN, BRIMONIDINE TARTRATE
ELESTAT, EPINASTINE HYDROCHLORIDE
LASTACAFT, ALCAFTADINE
LATISSE, BIMATOPROST
LUMIGAN, BIMATOPROST
OCUFLOX, OFLOXACIN
OZURDEX, DEXAMETHASONE
RESTASIS, CYCLOSPORINE
SANCTURA XR, TROSPIUM CHLORIDE
SANCTURA, TROSPIUM CHLORIDE
B - 7
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 8
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ALLERGAN INC
TAZORAC, TAZAROTENE
ZYMAR, GATIFLOXACIN
* ALLERGAN PHARMACEUTICAL
FML, FLUOROMETHOLONE
ALLERQUEST
* ALLERQUEST LLC
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
ALLIED PHARMA INC
* ALLIED PHARMA INC
CLARITHROMYCIN, CLARITHROMYCIN
GABAPENTIN, GABAPENTIN
ALLOS
* ALLOS THERAPEUTICS INC
FOLOTYN, PRALATREXATE
ALMATICA PHARMA INC
* ALMATICA PHARMA INC
NAPRELAN, NAPROXEN SODIUM
ALPHARMA
* ALPHARMA USPD INC
PREDNISOLONE, PREDNISOLONE
VALPROIC ACID, VALPROIC ACID
ALPHARMA KING
* ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS
EMBEDA, MORPHINE SULFATE
ALTAIRE PHARMS INC
* ALTAIRE PHARMACEUTICALS INC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE
OFLOXACIN, OFLOXACIN
ALTERNA TCHP LLC
* ALTERNA TCHP LLC
CHILDREN'S ELIXSURE, IBUPROFEN
(OTC)
ALVOGEN
* ALVOGEN INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
ALVOGEN INC
* ALVOGEN INC
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
ALVOGEN PINE BROOK
* ALVOGEN PINE BROOK INC
DISULFIRAM , DISULFIRAM
AM ANTIBIOTICS
* AMERICAN ANTIBIOTICS INC
AMOXICILLIN, AMOXICILLIN
AMAG PHARMS INC
* AMAG PHARMACEUTICALS INC
FERAHEME, FERUMOXYTOL
AMARIN PHARMS
* AMARIN PHARMACEUTICALS IRELAND LTD
VASCEPA, ICOSAPENT ETHYL
AMDERMA PHARMS
* AMDERMA PHARMACEUTICALS LLC
ECOZA, ECONAZOLE NITRATE
AMEDRA PHARMS
* AMEDRA PHARMACEUTICALS LLC
ADRENACLICK, EPINEPHRINE
ALBENZA, ALBENDAZOLE
(OTC)
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 9
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AMEDRA PHARMACEUTICALS LLC
DARAPRIM, PYRIMETHAMINE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
HYDROCORTISONE, HYDROCORTISONE
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE
AMGEN
* AMGEN INC
SENSIPAR, CINACALCET HYDROCHLORIDE
AMNEAL PHARM
* AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FOLIC ACID, FOLIC ACID
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
AMNEAL PHARMS
* AMNEAL PHARMACEUTICALS
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELBAMATE, FELBAMATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN
(OTC)
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METAXALONE, METAXALONE
NITROFURANTOIN, NITROFURANTOIN
NIZATIDINE, NIZATIDINE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SPIRONOLACTONE, SPIRONOLACTONE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
* AMNEAL PHARMACEUTICALS LLC
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* AMNEAL PHARMACEUTICALS OF NEW YORK LLC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
AMNEAL PHARMS NY
* AMNEAL PHARMACEUTICALS NY LLC
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AMNEAL PHARMACEUTICALS NY LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
REPREXAIN, HYDROCODONE BITARTRATE
AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTICAL INC
AMPHADASE, HYALURONIDASE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
AMPHASTAR PHARMS INC
* AMPHASTAR PHARMACEUTICALS INC
CORTROSYN, COSYNTROPIN
AMPOLGEN
* AMPOLGEN PHARMACEUTICALS LLC
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
AMYLIN
* AMYLIN PHARMACEUTICALS INC
BYDUREON, EXENATIDE SYNTHETIC
BYETTA, EXENATIDE SYNTHETIC
AMYLIN PHARMS LLC
* AMYLIN PHARMACEUTICALS LLC
SYMLIN, PRAMLINTIDE ACETATE
ANBEX
* ANBEX INC
IOSAT, POTASSIUM IODIDE
(OTC)
ANCHEN PHARMS
* ANCHEN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRETINOIN, TRETINOIN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* ANCHEN PHARMACEUTICALS TAIWAN INC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM, ALPRAZOLAM
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ANDRX LABS LLC
* ANDRX LABS LLC
ALTOPREV, LOVASTATIN
FORTAMET, METFORMIN HYDROCHLORIDE
ANGELINI PHARMA
* ANGELINI PHARMA INC
OLEPTRO, TRAZODONE HYDROCHLORIDE
ANI PHARMS
* ANI PHARMACEUTICALS INC
CORTENEMA, HYDROCORTISONE
LACTULOSE, LACTULOSE
LUVOX, FLUVOXAMINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ANTARES PHARMA INC
* ANTARES PHARMA INC
OTREXUP, METHOTREXATE
ANTIBIOTICE
* ANTIBIOTICE SA
NAFCILLIN SODIUM, NAFCILLIN SODIUM
B - 10
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
ANTIBIOTICOS BRASIL
* ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN, CEFOXITIN SODIUM
APGDI
* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
MYRBETRIQ, MIRABEGRON
APOPHARMA INC
* APOPHARMA INC
FERRIPROX, DEFERIPRONE
APOTEX
* APOTEX CORP
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
* APOTEX INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CIMETIDINE, CIMETIDINE
(OTC)
DILT-CD, DILTIAZEM HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPLERENONE, EPLERENONE
FAMCICLOVIR, FAMCICLOVIR
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMIVUDINE, LAMIVUDINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
RAMIPRIL, RAMIPRIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
APOTEX CORP
* APOTEX CORP
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
CABERGOLINE, CABERGOLINE
CLARITHROMYCIN, CLARITHROMYCIN
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RILUZOLE, RILUZOLE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
APOTEX INC
* APOTEX INC
ABACAVIR SULFATE, ABACAVIR SULFATE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
CALCITONIN-SALMON, CALCITONIN SALMON
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
B - 11
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* APOTEX INC
CARBAMAZEPINE, CARBAMAZEPINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFPROZIL, CEFPROZIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMIQUIMOD, IMIQUIMOD
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LAMIVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LOVASTATIN, LOVASTATIN
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NABUMETONE, NABUMETONE
NEVIRAPINE, NEVIRAPINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OXCARBAZEPINE, OXCARBAZEPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
RASAGILINE MESYLATE, RASAGILINE MESYLATE
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
CARVEDILOL, CARVEDILOL
GABAPENTIN, GABAPENTIN
MELOXICAM, MELOXICAM
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
TOPIRAMATE, TOPIRAMATE
* APOTEX INC RICHMOND HILL
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
FLUNISOLIDE, FLUNISOLIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
RISPERIDONE, RISPERIDONE
* APOTEX INC.
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
APOTHECON
* APOTHECON INC DIV BRISTOL MYERS SQUIBB
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
(OTC)
B - 12
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
APTALIS PHARMA
* APTALIS PHARMA LTD
RECTIV, NITROGLYCERIN
APTALIS PHARMA US
* APTALIS PHARMA US INC
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
CANASA, MESALAMINE
CARAFATE, SUCRALFATE
PYLERA, BISMUTH SUBCITRATE POTASSIUM
ULTRESA, PANCRELIPASE (AMYLASE
URSO 250, URSODIOL
URSO FORTE, URSODIOL
VIOKACE, PANCRELIPASE (AMYLASE
ZENPEP, PANCRELIPASE (AMYLASE
APTALIS PHARMATECH
* APTALIS PHARMATECH INC
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
AQUA PHARMS
* AQUA PHARMACEUTICALS
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
MONODOX, DOXYCYCLINE
* AQUA PHARMACEUTICALS LLC
FLUOROPLEX, FLUOROURACIL
XOLEGEL, KETOCONAZOLE
ARBOR PHARMS INC
* ARBOR PHARMACEUTICALS INC
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
BIDIL, HYDRALAZINE HYDROCHLORIDE
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
ERY-TAB, ERYTHROMYCIN
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN, ERYTHROMYCIN
NYMALIZE, NIMODIPINE
PCE, ERYTHROMYCIN
PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE
ARBOR PHARMS LLC
* ARBOR PHARMACEUTICALS LLC
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL
GLIADEL, CARMUSTINE
ARCO PHARMS LLC
* ARCO PHARMACEUTICALS LLC
THYROSHIELD, POTASSIUM IODIDE
(OTC)
AREVA PHARMS
* AREVA PHARMACEUTICALS INC
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
ARIAD
* ARIAD PHARMACEUTICALS INC
ICLUSIG, PONATINIB HYDROCHLORIDE
ASCEND
* ASCEND THERAPEUTICS INC
ESTROGEL, ESTRADIOL
ASPEN GLOBAL
* ASPEN GLOBAL INC
MYLERAN, BUSULFAN
ASPEN GLOBAL INC
* ASPEN GLOBAL INC
B - 13
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* ASPEN GLOBAL INC
LEUKERAN, CHLORAMBUCIL
THIOGUANINE, THIOGUANINE
ASTELLAS
* ASTELLAS PHARMA US INC
ADENOSCAN, ADENOSINE
ASTAGRAF XL, TACROLIMUS
LEXISCAN, REGADENOSON
MYCAMINE, MICAFUNGIN SODIUM
PROGRAF, TACROLIMUS
PROTOPIC, TACROLIMUS
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
XTANDI, ENZALUTAMIDE
ASTRAZENECA
* ASTRAZENECA LP
DUTOPROL, HYDROCHLOROTHIAZIDE
ENTOCORT EC, BUDESONIDE
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM
(OTC)
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PULMICORT FLEXHALER, BUDESONIDE
PULMICORT RESPULES, BUDESONIDE
RHINOCORT, BUDESONIDE
SEROQUEL, QUETIAPINE FUMARATE
SYMBICORT, BUDESONIDE
TOPROL-XL, METOPROLOL SUCCINATE
* ASTRAZENECA PHARMACEUTICALS LP
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
FASLODEX, FULVESTRANT
PLENDIL, FELODIPINE
SEROQUEL XR, QUETIAPINE FUMARATE
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
* ASTRAZENECA UK LTD
ACCOLATE, ZAFIRLUKAST
ARIMIDEX, ANASTROZOLE
CASODEX, BICALUTAMIDE
MERREM, MEROPENEM
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ASTRAZENECA LP
* ASTRAZENECA LP
BRILINTA, TICAGRELOR
ATON
* ATON PHARMA INC
CUPRIMINE, PENICILLAMINE
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
LACRISERT, HYDROXYPROPYL CELLULOSE
LODOSYN, CARBIDOPA
SYPRINE, TRIENTINE HYDROCHLORIDE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE
ATON PHARMA VPNA
* ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DEMSER, METYROSINE
AUROBINDO
* AUROBINDO PHARMA LTD
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
B - 14
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AUROBINDO PHARMA LTD
DIDANOSINE, DIDANOSINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NEVIRAPINE, NEVIRAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARM
* AUROBINDO PHARMA USA INC
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
AUROBINDO PHARMA
* AUROBINDO PHARMA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
* AUROBINDO PHARMA LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMPICILLIN SODIUM, AMPICILLIN SODIUM
ATENOLOL, ATENOLOL
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CARISOPRODOL, CARISOPRODOL
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MELOXICAM, MELOXICAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RIBAVARIN, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
B - 15
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AUROBINDO PHARMA LTD
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRANDOLAPRIL, TRANDOLAPRIL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
AUROBINDO PHARMA LTD
* AUROBINDO PHARMA LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LEVOFLOXACIN, LEVOFLOXACIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
* AUROBINDO PHARMA LTD
ABACAVIR SULFATE, ABACAVIR SULFATE
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FAMCICLOVIR, FAMCICLOVIR
FELODIPINE, FELODIPINE
FINASTERIDE, FINASTERIDE
GABAPENTIN, GABAPENTIN
GLIMEPIRIDE, GLIMEPIRIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MODAFINIL, MODAFINIL
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXACILLIN SODIUM, OXACILLIN SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
* AUROBINDO PHARMA LTD INC
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
B - 16
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 17
PRODUCT NAME SORTED BY APPLICANT
**
A
**
* AUROBINDO PHARMA LTD INC
CEPHALEXIN, CEPHALEXIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
MIRTAZAPINE, MIRTAZAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARMA USA
* AUROBINDO PHARMA USA INC
ALPRAZOLAM, ALPRAZOLAM
NAPROXEN, NAPROXEN
AUROLIFE PHARMA LLC
* AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
AUSTARPHARMA LLC
* AUSTARPHARMA LLC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
METHOCARBAMOL, METHOCARBAMOL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
AUXILIUM PHARMS
* AUXILIUM PHARMACEUTICALS INC
TESTIM, TESTOSTERONE
AVACOR PRODS
* AVACOR PRODUCTS LLC
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL
(OTC)
AVANIR PHARMS
* AVANIR PHARMACEUTICALS INC
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
AVANTHI INC
* AVANTHI INC
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE
(OTC)
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
AVEMA PHARMA
* AVEMA PHARMA SOLUTIONS
IBUPROFEN, IBUPROFEN
(OTC)
AVENT
* AVENT INC
PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14
AVEVA
* AVEVA DRUG DELIVERY SYSTEMS INC
CLONIDINE, CLONIDINE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
NICOTINE, NICOTINE
(OTC)
AVID RADIOPHARMS INC
* AVID RADIOPHARMACEUTICALS INC
AMYVID, FLORBETAPIR F-18
AZTIQ PHARMA
* AZTIQ PHARMA INC
TODAY, NONOXYNOL-9
(OTC)
**
B BRAUN
B
**
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 18
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* B BRAUN MEDICAL INC
AMINO ACIDS, AMINO ACIDS
BALANCED SALT, CALCIUM CHLORIDE
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NEPHRAMINE 5.4%, AMINO ACIDS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
BAJAJ MEDICAL LLC
* BAJAJ MECICAL LLC
DYNA-HEX, CHLORHEXIDINE GLUCONATE
(OTC)
BANNER PHARMACAPS
* BANNER PHARMACAPS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BENZONATATE, BENZONATATE
CALCITRIOL, CALCITRIOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
DUTASTERIDE, DUTASTERIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
(OTC)
IBUPROFEN, IBUPROFEN
(OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
(OTC)
MIDOL LIQUID GELS, IBUPROFEN
(OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
NIMODIPINE, NIMODIPINE
PROGESTERONE, PROGESTERONE
ZONISAMIDE, ZONISAMIDE
BARR
* BARR LABORATORIES INC
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ARANELLE, ETHINYL ESTRADIOL
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
BALZIVA-28, ETHINYL ESTRADIOL
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 19
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BARR LABORATORIES INC
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAMILA, NORETHINDRONE
CLONAZEPAM, CLONAZEPAM
CLONIDINE, CLONIDINE
DANAZOL, DANAZOL
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIDANOSINE, DIDANOSINE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DUTASTERIDE, DUTASTERIDE
ERRIN, NORETHINDRONE
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
JUNEL FE 1/20, ETHINYL ESTRADIOL
KARIVA, DESOGESTREL
KELNOR, ETHINYL ESTRADIOL
LEFLUNOMIDE, LEFLUNOMIDE
LESSINA-28, ETHINYL ESTRADIOL
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NIACIN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL
NORTREL 7/7/7, ETHINYL ESTRADIOL
ONDANSETRON, ONDANSETRON
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PORTIA-28, ETHINYL ESTRADIOL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
SPRINTEC, ETHINYL ESTRADIOL
TEMOZOLOMIDE, TEMOZOLOMIDE
TREXALL, METHOTREXATE SODIUM
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRI-SPRINTEC, ETHINYL ESTRADIOL
ZONISAMIDE, ZONISAMIDE
BARR LABS DIV TEVA
* BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
BARR LABS INC
* BARR LABORATORIES INC
ACITRETIN, ACITRETIN
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 20
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BARR LABORATORIES INC
ESTRADIOL, ESTRADIOL
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NIMODIPINE, NIMODIPINE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
TRETINOIN, TRETINOIN
BAUSCH AND LOMB
* BAUSCH AND LOMB INC
ALAWAY, KETOTIFEN FUMARATE
(OTC)
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALREX, LOTEPREDNOL ETABONATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ISTALOL, TIMOLOL MALEATE
LATANOPROST, LATANOPROST
LOTEMAX, LOTEPREDNOL ETABONATE
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
OFLOXACIN, OFLOXACIN
PROLENSA, BROMFENAC SODIUM
RETISERT, FLUOCINOLONE ACETONIDE
VITRASE, HYALURONIDASE
ZIRGAN, GANCICLOVIR
ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTICALS INC
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CROMOLYN SODIUM, CROMOLYN SODIUM
(OTC)
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
FLUNISOLIDE, FLUNISOLIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
CLINOLIPID 20%, OLIVE OIL
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BAXTER HEALTHCARE CORP
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ETHRANE, ENFLURANE
EXTRANEAL, ICODEXTRIN
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FORANE, ISOFLURANE
HEPATASOL 8%, AMINO ACIDS
IFEX, IFOSFAMIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
MESNEX, MESNA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NEXTERONE, AMIODARONE HYDROCHLORIDE
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
RENAMIN W/O ELECTROLYTES, AMINO ACIDS
SEVOFLURANE, SEVOFLURANE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STERILE WATER, STERILE WATER FOR IRRIGATION
SUPRANE, DESFLURANE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
BAXTER HLTHCARE CORP
* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
ATIVAN, LORAZEPAM
OXYTOCIN, OXYTOCIN
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
BAYER
* BAYER HEALTHCARE LLC
ALEVE-D SINUS & COLD, NAPROXEN SODIUM
(OTC)
FEMSTAT 3, BUTOCONAZOLE NITRATE
(OTC)
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE
(OTC)
MYCELEX-7, CLOTRIMAZOLE
(OTC)
B - 21
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BAYER HEALTHCARE LLC
RID MOUSSE, PIPERONYL BUTOXIDE
(OTC)
BAYER HLTHCARE
* BAYER HEALTHCARE PHARMACEUTICALS INC
ADALAT CC, NIFEDIPINE
ADEMPAS, RIOCIGUAT
ANGELIQ, DROSPIRENONE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
BEYAZ, DROSPIRENONE
BILTRICIDE, PRAZIQUANTEL
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
DESONATE, DESONIDE
DTIC-DOME, DACARBAZINE
EOVIST, GADOXETATE DISODIUM
FINACEA, AZELAIC ACID
GADAVIST, GADOBUTROL
LEVITRA, VARDENAFIL HYDROCHLORIDE
NATAZIA, DIENOGEST
NEXAVAR, SORAFENIB TOSYLATE
PRECOSE, ACARBOSE
SAFYRAL, DROSPIRENONE
SKYLA, LEVONORGESTREL
STAXYN, VARDENAFIL HYDROCHLORIDE
STIVARGA, REGORAFENIB
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
XOFIGO, RADIUM RA-223 DICHLORIDE
YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE
BAYSHORE PHARMS LLC
* BAYSHORE PHARMACEUTICALS LLC
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
BD RX
* BD RX INC
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
BECTON DICKINSON
* BECTON DICKINSON AND CO
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
(OTC)
BEDFORD
* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ADENOSINE, ADENOSINE
AMIKACIN SULFATE, AMIKACIN SULFATE
AMRINONE LACTATE, INAMRINONE LACTATE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM
AZTREONAM, AZTREONAM
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CEFTRIAXONE, CEFTRIAXONE SODIUM
CISPLATIN, CISPLATIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DACARBAZINE, DACARBAZINE
DACTINOMYCIN, DACTINOMYCIN
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
B - 22
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ETOPOSIDE, ETOPOSIDE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
HALOPERIDOL, HALOPERIDOL LACTATE
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVOCARNITINE, LEVOCARNITINE
MESNA, MESNA
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MILRINONE LACTATE, MILRINONE LACTATE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
THIOTEPA, THIOTEPA
VALPROATE SODIUM, VALPROATE SODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
BEDFORD LABS
* BEDFORD LABORATORIES
ALLOPURINOL SODIUM, ALLOPURINOL SODIUM
CAFCIT, CAFFEINE CITRATE
CARBOPLATIN, CARBOPLATIN
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LORAZEPAM PRESERVATIVE FREE, LORAZEPAM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PENTOSTATIN, PENTOSTATIN
TORSEMIDE, TORSEMIDE
BELCHER PHARMS
B - 23
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BELCHER PHARMACEUTICALS LLC
CEPHALEXIN, CEPHALEXIN
DESLORATADINE, DESLORATADINE
BEN VENUE
* BEN VENUE LABORATORIES INC
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
BEXIMCO USA
* BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL, CARVEDILOL
BICON PHARM
* BICON PHARMACEUTICAL INC
FOLIC ACID, FOLIC ACID
BIO NUCLEONICS
* BIO NUCLEONICS INC
STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89
BIO PHARM INC
* BIO PHARM INC
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
BIOCODEX INC
* BIOCODEX INC
TOTECT, DEXRAZOXANE HYDROCHLORIDE
BIOGEN IDEC INC
* BIOGEN IDEC INC
TECFIDERA, DIMETHYL FUMARATE
BIOKEY
* BIOKEY INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
BIOMARIN PHARM
* BIOMARIN PHARMACEUTICAL INC
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
BLU CARIBE
* BLU CARIBE INC
GEMFIBROZIL, GEMFIBROZIL
SIMVASTATIN, SIMVASTATIN
BLU CARIBE INC
* BLU CARIBE INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
BOEHRINGER INGELHEIM
* BOEHRINGER INGELHEIM
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
GILOTRIF, AFATINIB DIMALEATE
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE
(OTC)
ZANTAC 75, RANITIDINE HYDROCHLORIDE
(OTC)
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC
AGGRENOX, ASPIRIN
APTIVUS, TIPRANAVIR
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE
FLOMAX, TAMSULOSIN HYDROCHLORIDE
JENTADUETO, LINAGLIPTIN
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MOBIC, MELOXICAM
B - 24
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC
PERSANTINE, DIPYRIDAMOLE
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE
TRADJENTA, LINAGLIPTIN
TWYNSTA, AMLODIPINE BESYLATE
VIRAMUNE XR, NEVIRAPINE
VIRAMUNE, NEVIRAPINE
BRACCO
* BRACCO DIAGNOSTICS INC
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
PROHANCE MULTIPACK, GADOTERIDOL
SINOGRAFIN, DIATRIZOATE MEGLUMINE
BRAINTREE
* BRAINTREE LABORATORIES INC
AXID, NIZATIDINE
GOLYTELY, POLYETHYLENE GLYCOL 3350
HALFLYTELY, BISACODYL
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
BRAINTREE LABS
* BRAINTREE LABORATORIES INC
SUCLEAR, MAGNESIUM SULFATE
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS
BRECKENRIDGE PHARM
* BRECKENRIDGE PHARMACEUTICAL INC
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
LEVETIRACETAM, LEVETIRACETAM
MEFENAMIC ACID, MEFENAMIC ACID
MELOXICAM, MELOXICAM
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
OXCARBAZEPINE, OXCARBAZEPINE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
BRISTOL MYERS SQUIBB
* BRISTOL MYERS SQUIBB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVIR
GLUCOVANCE, GLYBURIDE
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
LYSODREN, MITOTANE
MEGACE, MEGESTROL ACETATE
PRAVACHOL, PRAVASTATIN SODIUM
* BRISTOL MYERS SQUIBB CO
DROXIA, HYDROXYUREA
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
IXEMPRA KIT, IXABEPILONE
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
REYATAZ, ATAZANAVIR SULFATE
SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ
VIDEX EC, DIDANOSINE
* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ELIQUIS, APIXABAN
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
VIDEX, DIDANOSINE
ZERIT, STAVUDINE
B - 25
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
B
**
**
C
**
BRYAN
* BRYAN CORP
TALC, TALC
CADENCE PHARMS
* CADENCE PHARMACEUTICALS INC
OFIRMEV, ACETAMINOPHEN
CADILA PHARMS LTD
* CADILA PHARMACEUTICALS LTD
ACYCLOVIR, ACYCLOVIR
CADISTA PHARMS
* CADISTA PHARMACEUTICALS INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
LAMOTRIGINE, LAMOTRIGINE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
OXCARBAZEPINE, OXCARBAZEPINE
CARACO
* CARACO PHARMACEUTICAL LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
BENZONATATE, BENZONATATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLONAZEPAM, CLONAZEPAM
CLOZAPINE, CLOZAPINE
ELIXOPHYLLIN, THEOPHYLLINE
FLUMADINE, RIMANTADINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
GEMFIBROZIL, GEMFIBROZIL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
MELOXICAM, MELOXICAM
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NITROFURANTOIN, NITROFURANTOIN
OXAPROZIN, OXAPROZIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
B - 26
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
C
**
* CARACO PHARMACEUTICAL LABORATORIES LTD
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPAGLINIDE, REPAGLINIDE
SYNALGOS-DC, ASPIRIN
THEOCHRON, THEOPHYLLINE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CARDINAL HEALTH 414
* CARDINAL HEALTH 414 LLC
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES
AMMONIA N 13, AMMONIA N-13
CARDINAL HLTH 414
* CARDINAL HEALTH 414
SODIUM IODIDE I 123, SODIUM IODIDE I-123
CAREFUSION
* CAREFUSION 213 LLC
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE
(OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE
(OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE
(OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE
(OTC)
CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE
(OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE
(OTC)
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE
(OTC)
CARLSBAD
* CARLSBAD TECHNOLOGY INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
GLIMEPIRIDE, GLIMEPIRIDE
LOVASTATIN, LOVASTATIN
MELOXICAM, MELOXICAM
MODAFINIL, MODAFINIL
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CAROLINA MEDCL
* CAROLINA MEDICAL PRODUCTS CO
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
ISONIAZID, ISONIAZID
SPS, SODIUM POLYSTYRENE SULFONATE
CATALENT
* CATALENT PHARMA SOLUTIONS LLC
VALPROIC ACID, VALPROIC ACID
CEDAR PHARMS
* CEDAR PHARMACEUTICALS LLC
METHIMAZOLE, METHIMAZOLE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
CELGENE
* CELGENE CORP
ISTODAX, ROMIDEPSIN
POMALYST, POMALIDOMIDE
REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE
VIDAZA, AZACITIDINE
CEPHALON
* CEPHALON INC
ACTIQ, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
GABITRIL, TIAGABINE HYDROCHLORIDE
NUVIGIL, ARMODAFINIL
B - 27
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
C
**
* CEPHALON INC
PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRISENOX, ARSENIC TRIOXIDE
CEREXA
* CEREXA INC
TEFLARO, CEFTAROLINE FOSAMIL
CHARTWELL LIFE SCI
* CHARTWELL LIFE SCIENCE LLC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
CHATTEM
* CHATTEM INC
SELSUN, SELENIUM SULFIDE
UNISOM, DOXYLAMINE SUCCINATE
(OTC)
CHEMISCH FBRK KRSSLR
* CHEMISCHE FABRIK KREUSSLER & CO. GMBH
ASCLERA, POLIDOCANOL
CHIRHOCLIN
* CHIRHOCLIN INC
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CIPHER PHARMS INC
* CIPHER PHARMACEUTICALS INC
CONZIP, TRAMADOL HYDROCHLORIDE
LIPOFEN, FENOFIBRATE
CIPLA
* CIPLA LTD
NEVIRAPINE, NEVIRAPINE
RISPERIDONE, RISPERIDONE
ZIDOVUDINE, ZIDOVUDINE
CIPLA LTD
* CIPLA LTD
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARBOPLATIN, CARBOPLATIN
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FAMCICLOVIR, FAMCICLOVIR
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRBESARTAN, IRBESARTAN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
STAVUDINE, STAVUDINE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CITIUS PHARMS
* CITIUS PHARMACEUTICALS LLC
SUPRENZA, PHENTERMINE HYDROCHLORIDE
CITRON PHARMA LLC
B - 28
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
C
**
* CITRON PHARMA LLC
ANTIVERT, MECLIZINE HYDROCHLORIDE
CORTISPORIN, HYDROCORTISONE
THALITONE, CHLORTHALIDONE
CLARIS LIFESCIENCES
* CLARIS LIFESCIENCES LIMITED
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
* CLARIS LIFESCIENCES LTD
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOFLOXACIN, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
CLINIGEN HLTHCARE
* CLINIGEN HEALTHCARE LTD
FOSCAVIR, FOSCARNET SODIUM
CLONMEL HLTHCARE
* CLONMEL HEALTHCARE LTD
MORPHINE SULFATE, MORPHINE SULFATE
CLOVER PHARMS
* CLOVER PHARMACEUTICALS CORP
AMICAR, AMINOCAPROIC ACID
CNTY LINE PHARMS
* COUNTY LINE PHARMACEUTICALS LLC
UREX, METHENAMINE HIPPURATE
COASTAL PHARMS
* COASTAL PHARMACEUTICALS
BROMFENAC SODIUM, BROMFENAC SODIUM
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
CONCORDIA PHARMS INC
* CONCORDIA PHARMACEUTICALS INC
KAPVAY, CLONIDINE HYDROCHLORIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAPRED, PREDNISOLONE SODIUM PHOSPHATE
CONTRACT PHARMACAL
* CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CIMETIDINE, CIMETIDINE
(OTC)
FOLIC ACID, FOLIC ACID
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN
(OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
(OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
PREDNISONE, PREDNISONE
PROFEN, IBUPROFEN
(OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
CORCEPT THERAP
* CORCEPT THERAPEUTICS INC
KORLYM, MIFEPRISTONE
CORDEN PHARMA
* CORDEN PHARMA LATINA SPA
CEENU, LOMUSTINE
B - 29
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 30
PRODUCT NAME SORTED BY APPLICANT
**
C
**
COREPHARMA
* COREPHARMA LLC
ALPRAZOLAM, ALPRAZOLAM
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LEVOCARNITINE, LEVOCARNITINE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
POTASSIUM CITRATE, POTASSIUM CITRATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL
CORNERSTONE THERAP
* CORNERSTONE THERAPEUTICS INC
BETHKIS, TOBRAMYCIN
CUROSURF, PORACTANT ALFA
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
COVIDIEN
* COVIDIEN
LYMPHAZURIN, ISOSULFAN BLUE
COVIS PHARMA
* COVIS PHARMA SARL
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
PARNATE, TRANYLCYPROMINE SULFATE
ZANTAC, RANITIDINE HYDROCHLORIDE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINACEF, CEFUROXIME SODIUM
COVIS PHARMA SARL
* COVIS PHARMA SARL
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
NILANDRON, NILUTAMIDE
RILUTEK, RILUZOLE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
CPPI CV
* CP PHARMACEUTICALS INTERNATIONAL CV
SUTENT, SUNITINIB MALATE
CREALTA PHARMS LLC
* CREALTA PHARMACEUTICALS LLC
MIGERGOT, CAFFEINE
CROWN LABS
* CROWN LABORATORIES INC
ALA-CORT, HYDROCORTISONE
ALA-SCALP, HYDROCORTISONE
TRIDERM, TRIAMCINOLONE ACETONIDE
CSL BEHRING
* CSL BEHRING LLC
STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
CSPC OUYI PHARM CO
* CSPC OUYI PHARMACEUTICAL CO LTD
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
C
**
* CSPC OUYI PHARMACEUTICAL CO LTD
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
CUBIST
* CUBIST PHARMACEUTICALS INC
CUBICIN, DAPTOMYCIN
CUBIST PHARMS
* CUBIST PHARMACEUTICALS INC
ENTEREG, ALVIMOPAN
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTICALS INC
ACETADOTE, ACETYLCYSTEINE
CALDOLOR, IBUPROFEN
LACTULOSE, LACTULOSE
CYPRESS BIOSCIENCE
* CYPRESS BIOSCIENCE INC
SAVELLA, MILNACIPRAN HYDROCHLORIDE
CYPRESS PHARM
* CYPRESS PHARMACEUTICAL INC
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
ELIPHOS, CALCIUM ACETATE
REZIRA, HYDROCODONE BITARTRATE
VITUZ, CHLORPHENIRAMINE MALEATE
ZUTRIPRO, CHLORPHENIRAMINE MALEATE
**
D
**
DAIICHI
* DAIICHI PHARMACEUTICAL CORP
FLOXIN OTIC, OFLOXACIN
DAIICHI SANKYO
* DAIICHI SANKYO INC
AZOR, AMLODIPINE BESYLATE
EVOXAC, CEVIMELINE HYDROCHLORIDE
TRIBENZOR, AMLODIPINE BESYLATE
WELCHOL, COLESEVELAM HYDROCHLORIDE
DANCO LABS LLC
* DANCO LABORATORIES LLC
MIFEPREX, MIFEPRISTONE
DARA BIOSCIENCES
* DARA BIOSCIENCES INC
SOLTAMOX, TAMOXIFEN CITRATE
DAVA INTL INC
* DAVA INTERNATIONAL INC
ALPRAZOLAM, ALPRAZOLAM
DAVA PHARMS INC
* DAVA PHARMACEUTICALS INC
ACYCLOVIR, ACYCLOVIR
AMOXICILLIN, AMOXICILLIN
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ATENOLOL, ATENOLOL
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DIAZEPAM, DIAZEPAM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
GEMFIBROZIL, GEMFIBROZIL
GLYBURIDE (MICRONIZED), GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
NAPROXEN, NAPROXEN
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PROPYLTHIOURACIL, PROPYLTHIOURACIL
B - 31
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
D
**
* DAVA PHARMACEUTICALS INC
PYRAZINAMIDE, PYRAZINAMIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
VOSPIRE ER, ALBUTEROL SULFATE
DELCOR ASSET
* DELCOR ASSET CORP
EVOCLIN, CLINDAMYCIN PHOSPHATE
LUXIQ, BETAMETHASONE VALERATE
OLUX E, CLOBETASOL PROPIONATE
ZOVIRAX, ACYCLOVIR
DELCOR ASSET CORP
* DELCOR ASSET CORP
ERYGEL, ERYTHROMYCIN
DENCO ASSET
* DENCO ASSET LLC
DENAVIR, PENCICLOVIR SODIUM
DENTSPLY PHARM
* DENTSPLY PHARMACEUTICAL INC
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
ORAQIX, LIDOCAINE
DEPOMED INC
* DEPOMED INC
GRALISE, GABAPENTIN
LAZANDA, FENTANYL CITRATE
ZIPSOR, DICLOFENAC POTASSIUM
DEPROCO
* DEPROCO INC
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DEXCEL LTD
* DEXCEL LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGIES LTD
OMEPRAZOLE, OMEPRAZOLE
(OTC)
PERIOCHIP, CHLORHEXIDINE GLUCONATE
DEY
* DEY LP
ACCUNEB, ALBUTEROL SULFATE
DUONEB, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
DIALYSIS SUPS
* DIALYSIS SUPPLIES INC
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
DIGESTIVE CARE INC
* DIGESTIVE CARE INC
PERTZYE, PANCRELIPASE (AMYLASE
DISCOVERY LABS
* DISCOVERY LABORATORIES INC
SURFAXIN, LUCINACTANT
DORADO PHARMA
* DORADO PHARMA LLC
KETOPROFEN, KETOPROFEN
DORC
* DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE
VISIONBLUE, TRYPAN BLUE
DOUGLAS PHARMS
* DOUGLAS PHARMACEUTICALS AMERICA LTD
MYORISAN, ISOTRETINOIN
B - 32
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
D
**
DOW PHARM
* DOW PHARMACEUTICAL SCIENCES
ACANYA, BENZOYL PEROXIDE
AKNE-MYCIN, ERYTHROMYCIN
ATRALIN, TRETINOIN
NUTRACORT, HYDROCORTISONE
OXSORALEN-ULTRA, METHOXSALEN
DR REDDYS LA
* DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
LOPURIN, ALLOPURINOL
SSD AF, SILVER SULFADIAZINE
SSD, SILVER SULFADIAZINE
DR REDDYS LABS INC
* DR REDDYS LABORATORIES INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMOXIL, AMOXICILLIN
AUGMENTIN '125', AMOXICILLIN
AUGMENTIN '200', AMOXICILLIN
AUGMENTIN '250', AMOXICILLIN
AUGMENTIN '400', AMOXICILLIN
AUGMENTIN '500', AMOXICILLIN
AUGMENTIN '875', AMOXICILLIN
AUGMENTIN ES-600, AMOXICILLIN
AUGMENTIN XR, AMOXICILLIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
LAROTID, AMOXICILLIN
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM
(OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SIMVASTATIN, SIMVASTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
DR REDDYS LABS LTD
* DR REDDYS LABORATORIES LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* DR REDDYS LABORATORIES LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZACITIDINE, AZACITIDINE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
B - 33
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
D
**
* DR REDDYS LABORATORIES LTD
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DECITABINE, DECITABINE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
(OTC)
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE
(OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN
(OTC)
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE, LANSOPRAZOLE
(OTC)
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
NAPROXEN SODIUM, NAPROXEN SODIUM
NATEGLINIDE, NATEGLINIDE
NIZATIDINE, NIZATIDINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM
(OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXAPROZIN, OXAPROZIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TACROLIMUS, TACROLIMUS
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
B - 34
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
D
**
* DR REDDYS LABORATORIES LTD
ZAFIRLUKAST, ZAFIRLUKAST
ZENATANE, ISOTRETINOIN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
DR REDDYS LABS SA
* DR REDDYS LABORATORIES SA
FENOFIBRATE (MICRONIZED), FENOFIBRATE
DRAXIMAGE
* DRAXIMAGE INC
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
DSM PHARMS INC
* DSM PHARMACEUTICALS INC
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
DUCHESNAY
* DUCHESNAY INC
DICLEGIS, DOXYLAMINE SUCCINATE
DURAMED PHARMS BARR
* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AVIANE-28, ETHINYL ESTRADIOL
DIAMOX, ACETAZOLAMIDE
ENPRESSE-28, ETHINYL ESTRADIOL
VELIVET, DESOGESTREL
DURAMED RES
* DURAMED RESEARCH INC
AYGESTIN, NORETHINDRONE ACETATE
REDDYS
* DOCTOR REDDYS LABORATORIES LTD
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
**
E
**
EAGLE PHARMS
* EAGLE PHARMACEUTICALS INC
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
EBEWE PHARMA
* EBEWE PHARMA
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
* EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN, CARBOPLATIN
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUOROURACIL, FLUOROURACIL
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ECLAT PHARMS LLC
* ECLAT PHARMACEUTICALS LLC
BLOXIVERZ, NEOSTIGMINE METHYLSULFATE
ECR
* ECR PHARMACEUTICALS
DEXAMETHASONE, DEXAMETHASONE
EDGEMONT PHARMS LLC
* EDGEMONT PHARMACEUTICALS LLC
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FORFIVO XL, BUPROPION HYDROCHLORIDE
EI INC
* EI INC
THEROXIDIL, MINOXIDIL
(OTC)
EISAI INC
* EISAI INC
ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM
B - 35
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
E
**
* EISAI INC
ACIPHEX, RABEPRAZOLE SODIUM
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
BANZEL, RUFINAMIDE
BELVIQ, LORCASERIN HYDROCHLORIDE
DACOGEN, DECITABINE
FRAGMIN, DALTEPARIN SODIUM
FYCOMPA, PERAMPANEL
HALAVEN, ERIBULIN MESYLATE
HEXALEN, ALTRETAMINE
PANRETIN, ALITRETINOIN
SALAGEN, PILOCARPINE HYDROCHLORIDE
ZONEGRAN, ZONISAMIDE
EKR THERAP
* EKR THERAPEUTICS INC
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE SR, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE
ELI LILLY AND CO
* ELI LILLY AND CO
AXIRON, TESTOSTERONE
EFFIENT, PRASUGREL HYDROCHLORIDE
PROZAC, FLUOXETINE HYDROCHLORIDE
SARAFEM, FLUOXETINE HYDROCHLORIDE
ELI LILLY CO
* ELI LILLY CO
ADCIRCA, TADALAFIL
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ELITE LABS
* ELITE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
EMCURE PHARMS
* EMCURE PHARMACEUTICALS LTD
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
EMCURE PHARMS INDIA
* EMCURE PHARMACEUTICALS LTD INDIA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL
EMCURE PHARMS LTD
* EMCURE PHARMACEUTICALS LTD
ACARBOSE, ACARBOSE
AMIKACIN SULFATE, AMIKACIN SULFATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BICNU, CARMUSTINE
CIDOFOVIR, CIDOFOVIR
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
EMCURE PHARMS USA
* EMCURE PHARMACEUTICALS USA INC
DIFLUNISAL, DIFLUNISAL
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
METHIMAZOLE, METHIMAZOLE
B - 36
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
E
**
* EMCURE PHARMACEUTICALS USA INC
NIFEDIPINE, NIFEDIPINE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
EMCURE USA
* EMCURE PHARMACEUTICALS USA INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
EMD SERONO
* EMD SERONO INC
EGRIFTA, TESAMORELIN ACETATE
GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
OVIDREL, CHORIOGONADOTROPIN ALFA
SAIZEN, SOMATROPIN RECOMBINANT
SEROPHENE, CLOMIPHENE CITRATE
SEROSTIM, SOMATROPIN RECOMBINANT
ZORBTIVE, SOMATROPIN RECOMBINANT
EMD SERONO INC
* EMD SERONO INC
CETROTIDE, CETRORELIX
EMMAUS MEDCL
* EMMAUS MEDICAL INC
NUTRESTORE, GLUTAMINE
ENDO PHARM
* ENDO PHARMACEUTICAL SOLUTIONS INC
SUPPRELIN LA, HISTRELIN ACETATE
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VANTAS, HISTRELIN ACETATE
ENDO PHARMS
* ENDO PHARMACEUTICALS INC
DELATESTRYL, TESTOSTERONE ENANTHATE
FORTESTA, TESTOSTERONE
FROVA, FROVATRIPTAN SUCCINATE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
PERCODAN, ASPIRIN
EPIC PHARMA
* EPIC PHARMA INC
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
* EPIC PHARMA LLC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
SULINDAC, SULINDAC
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL
EPIC PHARMA INC
* EPIC PHARMA INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
EPIC PHARMA LLC
* EPIC PHARMA LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
ERGOJECT
* ERGOJECT LLC
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
ETHYPHARM
* ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
EURAND
B - 37
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
E
**
* EURAND AMERICA INC
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
EXALENZ BIOSCIENCE
* EXALENZ BIOSCIENCE LTD
IDKIT:HP, CITRIC ACID
EXCELLIUM
* EXCELLIUM PHARMACEUTICAL INC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
FOLIC ACID, FOLIC ACID
FUROSEMIDE, FUROSEMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
EXELA PHARMA SCIENCE
* EXELA PHARMA SCIENCES
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
EXELA PHARMA SCS LLC
* EXELA PHARMA SCIENCES LLC
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
EXELIXIS
* EXELIXIS INC
COMETRIQ, CABOZANTINIB S-MALATE
FOUGERA
* E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
FLUOCINONIDE, FLUOCINONIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE, LIDOCAINE
NITROGLYCERIN, NITROGLYCERIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
LILLY
* ELI LILLY AND CO
ALIMTA, PEMETREXED DISODIUM
CIALIS, TADALAFIL
CYMBALTA, DULOXETINE HYDROCHLORIDE
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
GEMZAR, GEMCITABINE HYDROCHLORIDE
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
**
F
**
FACTA FARMA
* FACTA FARMACEUTICI SPA
CEPHALEXIN, CEPHALEXIN
FALCON PHARMS
* FALCON PHARMACEUTICALS INC
TIMOLOL MALEATE, TIMOLOL MALEATE
* FALCON PHARMACEUTICALS LTD
METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
FAMY CARE LTD
* FAMY CARE LTD
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
B - 38
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
F
**
* FAMY CARE LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
FDC LTD
* FDC LTD
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
OFLOXACIN, OFLOXACIN
TIMOLOL MALEATE, TIMOLOL MALEATE
FEINSTEIN
* FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FERA PHARMS
* FERA PHARMACEUTICALS LLC
OFLOXACIN, OFLOXACIN
TOBRAMYCIN, TOBRAMYCIN
FERRING
* FERRING PHARMACEUTICALS INC
BRAVELLE, UROFOLLITROPIN
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
ENDOMETRIN, PROGESTERONE
FIRMAGON, DEGARELIX ACETATE
MENOPUR, MENOTROPINS (FSH
MINIRIN, DESMOPRESSIN ACETATE
REPRONEX, MENOTROPINS (FSH
TEV-TROPIN, SOMATROPIN RECOMBINANT
FERRING CONTROLLED
* FERRING CONTROLLED THERAPEUTICS LTD
CERVIDIL, DINOPROSTONE
FERRING PHARMS AS
* FERRING PHARMACEUTICALS AS
LYSTEDA, TRANEXAMIC ACID
PREPOPIK, CITRIC ACID
FOREST LABS
* FOREST LABORATORIES INC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
CAMPRAL, ACAMPROSATE CALCIUM
CELEXA, CITALOPRAM HYDROBROMIDE
LEXAPRO, ESCITALOPRAM OXALATE
NAMENDA XR, MEMANTINE HYDROCHLORIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
THYROLAR-0.25, LIOTRIX (T4
THYROLAR-0.5, LIOTRIX (T4
THYROLAR-1, LIOTRIX (T4
THYROLAR-2, LIOTRIX (T4
THYROLAR-3, LIOTRIX (T4
FOREST LABS INC
* FOREST LABORATORIES INC
FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE
LINZESS, LINACLOTIDE
TUDORZA PRESSAIR, ACLIDINIUM BROMIDE
VIIBRYD, VILAZODONE HYDROCHLORIDE
FOREST RES INST INC
* FOREST RESEARCH INSTITUTE INC
DALIRESP, ROFLUMILAST
FOUGERA PHARMS
* FOUGERA PHARMACEUTICALS INC
ACLOVATE, ALCLOMETASONE DIPROPIONATE
ADAPALENE, ADAPALENE
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMCINONIDE, AMCINONIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
B - 39
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
F
**
* FOUGERA PHARMACEUTICALS INC
C-SOLVE-2, ERYTHROMYCIN
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CUTIVATE, FLUTICASONE PROPIONATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE, HYDROCORTISONE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LIDOCAINE AND PRILOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
OXISTAT, OXICONAZOLE NITRATE
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
PREDNICARBATE, PREDNICARBATE
SOLARAZE, DICLOFENAC SODIUM
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOVATE, CLOBETASOL PROPIONATE
TERCONAZOLE, TERCONAZOLE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE
ZONALON, DOXEPIN HYDROCHLORIDE
FRESENIUS
* FRESENIUS KABI DEUTSCHLAND GMBH
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
FRESENIUS KABI
* FRESENIUS KABI AUSTRIA GMBH
LACTULOSE, LACTULOSE
FRESENIUS KABI ONCOL
* FRESENIUS KABI ONCOLOGY PLC
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
LETROZOLE, LETROZOLE
OXALIPLATIN, OXALIPLATIN
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
FRESENIUS KABI USA
* FRESENIUS KABI USA LLC
CLADRIBINE, CLADRIBINE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIMENHYDRINATE, DIMENHYDRINATE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
B - 40
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
F
FRESENIUS MEDCL
* FRESENIUS MEDICAL CARE NORTH AMERICA
CALCITRIOL, CALCITRIOL
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSLYRA, CALCIUM ACETATE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
FSC
* FSC LABORATORIES INC
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
**
G
**
SODIUM CHLORIDE
**
G AND W LABS
* G AND W LABORATORIES INC
CICLOPIROX, CICLOPIROX
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
INDOMETHACIN, INDOMETHACIN
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
PROCHLORPERAZINE, PROCHLORPERAZINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
G AND W LABS INC
* G AND W LABORATORIES INC
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
FLUOCINONIDE, FLUOCINONIDE
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE NITRATE, MICONAZOLE NITRATE
(OTC)
GALDERMA LABS
* GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE
GALDERMA LABS LP
* GALDERMA LABORATORIES L P
CLOBEX, CLOBETASOL PROPIONATE
* GALDERMA LABORATORIES LP
CAPEX, FLUOCINOLONE ACETONIDE
CLOBEX, CLOBETASOL PROPIONATE
DESOWEN, DESONIDE
DIFFERIN, ADAPALENE
EPIDUO, ADAPALENE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
MIRVASO, BRIMONIDINE TARTRATE
ORACEA, DOXYCYCLINE
PERIOSTAT, DOXYCYCLINE HYCLATE
PLIAGLIS, LIDOCAINE
TRI-LUMA, FLUOCINOLONE ACETONIDE
VECTICAL, CALCITRIOL
GALEN (UK)
* GALEN LTD
DAUNOXOME, DAUNORUBICIN CITRATE
GALEN SPECIALTY
* GALEN SPECIALTY PHARMA US LLC
SYNERA, LIDOCAINE
GALENA BIOPHARMA
* GALENA BIOPHARMA
ABSTRAL, FENTANYL CITRATE
GAMBRO RENAL PRODS
* GAMBRO RENAL PRODUCTS
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
B - 41
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
G
**
* GAMBRO RENAL PRODUCTS
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
GASTROENTERO
* GASTROENTERO LOGIC LLC
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN
GATE PHARMS
* GATE PHARMACEUTICALS
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
GAVIS PHARMS
* GAVIS PHARMACEUTICALS LLC
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NYSTATIN, NYSTATIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
QUINARETIC, HYDROCHLOROTHIAZIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXIB
GD SEARLE LLC
* GD SEARLE LLC
ARTHROTEC, DICLOFENAC SODIUM
CALAN, VERAPAMIL HYDROCHLORIDE
CYTOTEC, MISOPROSTOL
FLAGYL ER, METRONIDAZOLE
FLAGYL, METRONIDAZOLE
INSPRA, EPLERENONE
GE HEALTHCARE
* GE HEALTHCARE
ADREVIEW, IOBENGUANE SULFATE I-123
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
METASTRON, STRONTIUM CHLORIDE SR-89
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
OMNISCAN, GADODIAMIDE
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VIZAMYL, FLUTEMETAMOL F-18
GE HLTHCARE INC
* GE HEALTHCARE INC
DATSCAN, IOFLUPANE I-123
GEDEON RICHTER USA
* GEDEON RICHTER USA INC
FINASTERIDE, FINASTERIDE
GENENTECH
* GENENTECH INC
ERIVEDGE, VISMODEGIB
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT
GENZYME
* GENZYME CORP
CLOLAR, CLOFARABINE
B - 42
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
G
**
* GENZYME CORP
MOZOBIL, PLERIXAFOR
RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE
GENZYME CORP
* GENZYME CORP
HECTOROL, DOXERCALCIFEROL
KYNAMRO, MIPOMERSEN SODIUM
GILEAD
* GILEAD SCIENCES INC
ATRIPLA, EFAVIRENZ
CAYSTON, AZTREONAM
EMTRIVA, EMTRICITABINE
HEPSERA, ADEFOVIR DIPIVOXIL
LETAIRIS, AMBRISENTAN
RANEXA, RANOLAZINE
TRUVADA, EMTRICITABINE
GILEAD SCIENCES INC
* GILEAD SCIENCES INC
COMPLERA, EMTRICITABINE
SOLVADI, SOFOSBUVIR
STRIBILD, COBICISTAT
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VISTIDE, CIDOFOVIR
GLAND PHARMA LTD
* GLAND PHARMA LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
HALOPERIDOL, HALOPERIDOL LACTATE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
GLATT AIR
* GLATT AIR TECHNIQUES INC
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
GLAXO GRP LTD
* GLAXO GROUP LTD DBA GLAXOSMITHKLINE
ALTABAX, RETAPAMULIN
FLOVENT HFA, FLUTICASONE PROPIONATE
SEREVENT, SALMETEROL XINAFOATE
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
ANORO ELLIPTA, UMECLIDINIUM BROMIDE
BREO ELLIPTA, FLUTICASONE FUROATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
VENTOLIN HFA, ALBUTEROL SULFATE
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
GLAXO WELLCOME
* GLAXOSMITHKLINE
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
GLAXOSMITHKLINE
* GLAXOSMITHKLINE
ALKERAN, MELPHALAN HYDROCHLORIDE
ARIXTRA, FONDAPARINUX SODIUM
AVODART, DUTASTERIDE
B - 43
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
G
**
* GLAXOSMITHKLINE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
CEFTIN, CEFUROXIME AXETIL
EPIVIR-HBV, LAMIVUDINE
FLONASE, FLUTICASONE PROPIONATE
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMITREX, SUMATRIPTAN SUCCINATE
JALYN, DUTASTERIDE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
NICORETTE (MINT), NICOTINE POLACRILEX
(OTC)
NICORETTE, NICOTINE POLACRILEX
(OTC)
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
POTIGA, EZOGABINE
PROMACTA, ELTROMBOPAG OLAMINE
RELENZA, ZANAMIVIR
TAFINLAR, DABRAFENIB MESYLATE
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VERAMYST, FLUTICASONE FUROATE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZYBAN, BUPROPION HYDROCHLORIDE
GLAXOSMITHKLINE CONS
* GLAXOSMITHKLINE CONSUMER HEALTHCARE
ALLI, ORLISTAT
(OTC)
COMMIT, NICOTINE POLACRILEX
(OTC)
NICORETTE, NICOTINE POLACRILEX
(OTC)
GLAXOSMITHKLINE LLC
* GLAXOSMITHKLINE LLC
AMERGE, NARATRIPTAN HYDROCHLORIDE
DYAZIDE, HYDROCHLOROTHIAZIDE
FLOLAN, EPOPROSTENOL SODIUM
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE
MEPRON, ATOVAQUONE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
REQUIP, ROPINIROLE HYDROCHLORIDE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
RYTHMOL, PROPAFENONE HYDROCHLORIDE
GLENMARK GENERICS
* GLENMARK GENERICS INC USA
ADAPALENE, ADAPALENE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
IMIQUIMOD, IMIQUIMOD
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN CALCIUM
NIZATIDINE, NIZATIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
* GLENMARK GENERICS LIMITED
BRIELLYN, ETHINYL ESTRADIOL
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* GLENMARK GENERICS LTD
B - 44
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
G
**
* GLENMARK GENERICS LTD
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ALYACEN 1/35, ETHINYL ESTRADIOL
ALYACEN 7/7/7, ETHINYL ESTRADIOL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESOXIMETASONE, DESOXIMETASONE
FELODIPINE, FELODIPINE
HEATHER, NORETHINDRONE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
MARLISSA, ETHINYL ESTRADIOL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NORETHIDRONE, NORETHINDRONE
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
RILUZOLE, RILUZOLE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
THEOPHYLLINE, THEOPHYLLINE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
URSODIOL, URSODIOL
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VIORELE, DESOGESTREL
ZOLMITRIPTAN, ZOLMITRIPTAN
* GLENMARK GENERICS LTD INDIA
INDOMETHACIN, INDOMETHACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK PHARMS
* GLENMARK PHARMACEUTICALS INC USA
CICLOPIROX, CICLOPIROX
CLOTRIMAZOLE, CLOTRIMAZOLE
MUPIROCIN, MUPIROCIN
* GLENMARK PHARMACEUTICALS LTD
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
GLENMARK PHARMS LTD
* GLENMARK PHARMACEUTICALS LTD
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
GRANULES INDIA
* GRANULES INDIA LTD
IBUPROFEN, IBUPROFEN
(OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
GUERBET
* GUERBET LLC
DOTAREM, GADOTERATE MEGLUMINE
HEXABRIX, IOXAGLATE MEGLUMINE
OXILAN-300, IOXILAN
OXILAN-350, IOXILAN
HANFORD GC
* GC HANFORD MANUFACTURING CO
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
B - 45
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
HAEMONETICS
* HAEMONETICS CORP
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
HALOCARBON PRODS
* HALOCARBON PRODUCTS CORP
SEVOFLURANE, SEVOFLURANE
HALOZYME THERAP
* HALOZYME THERAPEUTICS INC
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HAMELN RDS GMBH
* HAMELN RDS GMBH
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HANMI PHARM CO LTD
* HANMI PHARMACEUTICAL CO LTD
ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM
HARRIS PHARM
* HARRIS PHARMACEUTICAL INC
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
HAUPT PHARMA
* HAUPT PHARMA INC
NORETHINDRONE, NORETHINDRONE
HELSINN HLTHCARE
* HELSINN HEALTHCARE SA
ALOXI, PALONOSETRON HYDROCHLORIDE
HERCON PHARM
* HERCON PHARMACEUTICAL LLC
NITROGLYCERIN, NITROGLYCERIN
HERITAGE PHARMS INC
* HERITAGE PHARMACEUTICALS INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
FELODIPINE, FELODIPINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
LEFLUNOMIDE, LEFLUNOMIDE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NYSTATIN, NYSTATIN
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
SULINDAC, SULINDAC
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
HETERO LABS LTD III
* HETERO LABS LTD UNIT III
ABACAVIR SULFATE, ABACAVIR SULFATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FINASTERIDE, FINASTERIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
NEVIRAPINE, NEVIRAPINE
STAVUDINE, STAVUDINE
B - 46
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HETERO LABS LTD UNIT III
TORSEMIDE, TORSEMIDE
ZIDOVUDINE, ZIDOVUDINE
HETERO LABS LTD V
* HETERO LABS LTD UNIT V
ACYCLOVIR, ACYCLOVIR
IRBESARTAN, IRBESARTAN
LAMIVUDINE, LAMIVUDINE
HEYL CHEMISCH
* HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
HI TECH PHARMA
* HI TECH PHARMACAL CO INC
ACYCLOVIR, ACYCLOVIR
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
EMBELINE, CLOBETASOL PROPIONATE
ERYTHRO-STATIN, ERYTHROMYCIN
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOXIDIL (FOR WOMEN), MINOXIDIL
(OTC)
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TIMOLOL MALEATE, TIMOLOL MALEATE
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL
HI TECH PHARMA CO
* HI TECH PHARMACAL CO INC
FLUNISOLIDE, FLUNISOLIDE
PREDNISOLONE, PREDNISOLONE
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
HI-TECH PHARMA CO
* HI-TECH PHARMACAL CO INC
LORAZEPAM, LORAZEPAM
HI-TECH PHARMACAL
* HI-TECH PHARMACAL CO INC
LEVETIRACETAM, LEVETIRACETAM
HIKMA
* HIKMA FARMACEUTICA LDA
CEFOTAXIME, CEFOTAXIME SODIUM
* HIKMA PHARMACEUTICALS
AMOXICILLIN, AMOXICILLIN
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEPHALEXIN, CEPHALEXIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
GLYBURIDE (MICRONIZED), GLYBURIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
B - 47
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HIKMA PHARMACEUTICALS
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
HIKMA (MAPLE)
* HIKMA (MAPLE) LTD
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
HIKMA FARMACEUTICA
* HIKMA FARMACEUTICA (PORTUGAL) SA
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
VALPROATE SODIUM, VALPROATE SODIUM
* HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
* HIKMA FARMACEUTICA PORTUGAL SA
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
* HIKMA FARMACEUTICA SA
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HIKMA MAPLE
* HIKMA MAPLE LTD
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
BUMETANIDE, BUMETANIDE
CEFOXITIN, CEFOXITIN SODIUM
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIGOXIN, DIGOXIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOPRAM, DOXAPRAM HYDROCHLORIDE
DURAMORPH PF, MORPHINE SULFATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
B - 48
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HIKMA MAPLE LTD
FAMOTIDINE, FAMOTIDINE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
INFUMORPH, MORPHINE SULFATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOMYCIN, MITOMYCIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL
ROBINUL, GLYCOPYRROLATE
SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
HIKMA PHARM CO LTD
* HIKMA PHARM CO LTD
ARGATROBAN, ARGATROBAN
HIKMA PHARMS
* HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEPHALEXIN, CEPHALEXIN
DIGOXIN, DIGOXIN
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LISINOPRIL, LISINOPRIL
METHOCARBAMOL, METHOCARBAMOL
MODAFINIL, MODAFINIL
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOPIRAMATE , TOPIRAMATE
* HIKMA PHARMACEUTICALS LLC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
PREDNISONE, PREDNISONE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX
HIKMA PHARMS LLC
* HIKMA PHARMACEUTICALS LLC
DOXERCALCIFEROL, DOXERCALCIFEROL
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HILL DERMAC
* HILL DERMACEUTICALS INC
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMOTIC, FLUOCINOLONE ACETONIDE
HISAMITSU PHARM CO
* HISAMITSU PHARMACEUTICAL CO INC
SALONPAS, MENTHOL
(OTC)
B - 49
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
HISUN PHARM HANGZHOU
* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
HITECH PHARMA
* HITECH PHARMACAL CORP
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
HOFFMAN LA ROCHE
* HOFFMAN LA ROCHE INC
INVIRASE, SAQUINAVIR MESYLATE
HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE INC
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
BONIVA, IBANDRONATE SODIUM
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
XELODA, CAPECITABINE
XENICAL, ORLISTAT
ZELBORAF, VEMURAFENIB
HOPE PHARMS
* HOPE PHARMACEUTICALS
NITHIODOTE, SODIUM NITRITE
SODIUM NITRITE, SODIUM NITRITE
SODIUM THIOSULFATE, SODIUM THIOSULFATE
HORIZON PHARMA
* HORIZON PHARMA INC
DUEXIS, FAMOTIDINE
RAYOS, PREDNISONE
VIMOVO, ESOMEPRAZOLE MAGNESIUM
HOSPIRA
* HOSPIRA INC
A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACETYLCYSTEINE, ACETYLCYSTEINE
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
AMIDATE, ETOMIDATE
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE
B - 50
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 51
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HOSPIRA INC
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CYTARABINE, CYTARABINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIAZEPAM, DIAZEPAM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DROPERIDOL, DROPERIDOL
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FOSCARNET SODIUM, FOSCARNET SODIUM
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HOSPIRA INC
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISOFLURANE, ISOFLURANE
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LEVOPHED, NOREPINEPHRINE BITARTRATE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIPOSYN II 10%, SAFFLOWER OIL
LIPOSYN II 20%, SAFFLOWER OIL
LIPOSYN III 10%, SOYBEAN OIL
LIPOSYN III 20%, SOYBEAN OIL
LIPOSYN III 30%, SOYBEAN OIL
LORAZEPAM, LORAZEPAM
LTA II KIT, LIDOCAINE HYDROCHLORIDE
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID
M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
B - 52
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 53
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HOSPIRA INC
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPOFOL, PROPOFOL
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 54
PRODUCT NAME SORTED BY APPLICANT
**
H
**
* HOSPIRA INC
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TALWIN, PENTAZOCINE LACTATE
TAZICEF, CEFTAZIDIME
THAM, TROMETHAMINE
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VITAMIN K1, PHYTONADIONE
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
* HOSPIRA WORLDWIDE, INC
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NITROPRESS, SODIUM NITROPRUSSIDE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
HOSPIRA INC
* HOSPIRA INC
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
DOCETAXEL, DOCETAXEL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
LEVETIRACETAM, LEVETIRACETAM
MAXIPIME, CEFEPIME HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
MORPHINE SULFATE, MORPHINE SULFATE
NIPENT, PENTOSTATIN
OXALIPLATIN, OXALIPLATIN
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HOSPIRA WORLDWIDE
* HOSPIRA WORLDWIDE PTY
OXALIPLATIN, OXALIPLATIN
HOUSTON CYCLOTRON
* HOUSTON CYCLOTRON PARTNERS LP
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
HQ SPCLT PHARMA
* HQ SPECIALTY PHARMA CORP
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
** H
**
* HQ SPECIALTY PHARMA CORP
CISPLATIN, CISPLATIN
TAXOL, PACLITAXEL
HQ SPECIALITY PHARMA
* HQ SPECIALITY PHARMA LLC
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
HQ SPECLT PHARMA
* HQ SPECIALTY PHARMA
VUMON, TENIPOSIDE
HRA PHARMA
* HRA PHARMA LLC
METOPIRONE, METYRAPONE
HYPERION THERAP INC
* HYPERION THERAPEUTICS INC
RAVICTI, GLYCEROL PHENYLBUTYRATE
HYPERION THERAPS INC
* HYPERION THERAPEUTICS INC
BUPHENYL, SODIUM PHENYLBUTYRATE
ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
COPEGUS, RIBAVIRIN
FUZEON, ENFUVIRTIDE
TAMIFLU, OSELTAMIVIR PHOSPHATE
** I
**
IBI
* ISTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PIPERACILLIN, PIPERACILLIN SODIUM
IDENTI PHARMS INC
* IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
IGI LABS INC
* IGI LABORATORIES INC
ECONAZOLE NITRATE, ECONAZOLE NITRATE
IMPAX LABS
* IMPAX LABORATORIES INC
ACARBOSE, ACARBOSE
ALPRAZOLAM, ALPRAZOLAM
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
DANTROLENE SODIUM, DANTROLENE SODIUM
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DIGOXIN, DIGOXIN
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LETROZOLE, LETROZOLE
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE
(OTC)
B - 55
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
I
**
* IMPAX LABORATORIES INC
LORATADINE, LORATADINE
(OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
OMEPRAZOLE, OMEPRAZOLE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RILUZOLE, RILUZOLE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
IMPAX LABS INC
* IMPAX LABORATORIES INC
CABERGOLINE, CABERGOLINE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
IMPAX PHARMS
* IMPAX PHARMACEUTICALS
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE,
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
INCYTE CORP
* INCYTE CORP
JAKAFI, RUXOLITINIB PHOSPHATE
INDICUS PHARMA
* INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LETROZOLE, LETROZOLE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
INDOCO REMEDIES
* INDOCO REMEDIES LTD
GLIMEPIRIDE, GLIMEPIRIDE
INJECTALIA
* INJECTALIA SRL
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
INNOPHARMA LICENSING
* INNOPHARMA LICENSING LLC
ACETYLCYSTEINE, ACETYLCYSTEINE
INSIGHT PHARMS
* INSIGHT PHARMACEUTICALS CORP
MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3, MICONAZOLE NITRATE
(OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MONISTAT 7, MICONAZOLE NITRATE
(OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
NIX, PERMETHRIN
(OTC)
INST BIOCHEM
* INSTITUT BIOCHEMIQUE SA
FLECTOR, DICLOFENAC EPOLAMINE
INST BIOCHIMIQUE
* INSTITUTE BIOCHIMIQUE SA (IBSA)
TIROSINT, LEVOTHYROXINE SODIUM
INSTITUT BIOCHIMIQUE
FEXOFENADINE
(OTC)
B - 56
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
I
**
* INSTITUT BIOCHIMIQUE SA IBSA
TIROSINT, LEVOTHYROXINE SODIUM
INSYS THERAP
* INSYS THERAPEUTICS INC
DRONABINOL, DRONABINOL
SUBSYS, FENTANYL
INTELLIPHARMACEUTICS
* INTELLIPHARMACEUTICS CORP
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
INTERGEL PHARM
* INTERGEL PHARMACEUTICAL INC
NIFEDIPINE, NIFEDIPINE
INTL MEDICATED
* INTERNATIONAL MEDICATED SYSTEMS LTD
MILRINONE LACTATE, MILRINONE LACTATE
INTL MEDICATION
* INTERNATIONAL MEDICATION SYSTEM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
PHYTONADIONE, PHYTONADIONE
* INTERNATIONAL MEDICATION SYSTEMS LTD
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
INTL MEDICATION SYS
* INTERNATIONAL MEDICATION SYSTEMS LTD
LORAZEPAM, LORAZEPAM
INVAGEN PHARMS
* INVAGEN PHARMACEUTICALS INC
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CALCIUM ACETATE, CALCIUM ACETATE
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FOLIC ACID, FOLIC ACID
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL, LISINOPRIL
MEPROBAMATE, MEPROBAMATE
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
WARFARIN SODIUM, WARFARIN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
INVENTIA HLTHCARE
* INVENTIA HEALTHCARE PRIVATE LTD
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
IPCA LABS LTD
* IPCA LABORATORIES LTD
B - 57
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
I
**
* IPCA LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
IPR
* IPR PHARMACEUTICALS INC
CRESTOR, ROSUVASTATIN CALCIUM
ZOMIG, ZOLMITRIPTAN
IPR PHARMS INC
* IPR PHARMACEUTICALS INC
CAPRELSA, VANDETANIB
IPSEN INC
* IPSEN BIOPHARMACEUTICALS INC
INCRELEX, MECASERMIN RECOMBINANT
IPSEN PHARMA
* IPSEN PHARMA BIOTECH SAS
SOMATULINE DEPOT, LANREOTIDE ACETATE
IROKO PHARMS
* IROKO PHARMACEUTICALS LLC
INDOCIN, INDOMETHACIN
IROKO PHARMS LLC
* IROKO PHARMACEUTICALS LLC
ZORVOLEX, DICLOFENAC
ISO TEX
* ISO TEX DIAGNOSTICS INC
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
ISOTEX
* ISOTEX DIAGNOSTICS
GLOFIL-125, IOTHALAMATE SODIUM I-125
ISTA PHARMS INC
* ISTA PHARMACEUTICALS INC
BEPREVE, BEPOTASTINE BESILATE
BROMDAY, BROMFENAC SODIUM
ISTITUTO BIO ITA SPA
* ISTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
IVAX INTL
* IVAX INTERNATIONAL GMBH
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
SYNRIBO, OMACETAXINE MEPESUCCINATE
IVAX PHARMS
* IVAX PHARMACEUTICALS INC
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
IVAX SUB TEVA PHARMS
* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FLUTAMIDE, FLUTAMIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OXAZEPAM, OXAZEPAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
**
J
**
B - 58
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
J
**
JANSSEN BIOTECH
* JANSSEN BIOTECH INC
ZYTIGA, ABIRATERONE ACETATE
JANSSEN PHARMS
* JANSSEN PHARMACEUTICALS INC
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVOKANA, CANAGLIFLOZIN
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
ORTHO EVRA, ETHINYL ESTRADIOL
RISPERDAL, RISPERIDONE
TOPAMAX, TOPIRAMATE
XARELTO, RIVAROXABAN
JANSSEN PRODS
* JANSSEN PRODUCTS LP
EDURANT, RILPIVIRINE HYDROCHLORIDE
PREZISTA, DARUNAVIR ETHANOLATE
JANSSEN R AND D
* JANSSEN RESEARCH AND DEVELOPMENT LLC
INTELENCE, ETRAVIRINE
PARAFON FORTE DSC, CHLORZOXAZONE
JANSSEN RES AND DEV
* JANSSEN RESEARCH AND DEVELOPMENT LLC
DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
OLYSIO, SIMEPREVIR
JANSSEN THERAP
* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
SIRTURO, BEDAQUILINE FUMARATE
JAZZ PHARMS
* JAZZ PHARMACEUTICALS INC
LUVOX CR, FLUVOXAMINE MALEATE
XYREM, SODIUM OXYBATE
JAZZ PHARMS III
* JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
FAZACLO ODT, CLOZAPINE
* JAZZ PHARMACEUTICALS INTERNATIONAL III
VERSACLOZ, CLOZAPINE
JAZZ PHARMS INTL
* JAZZ PHARMACEUTICALS INTERNATIONAL LTD
PRIALT, ZICONOTIDE ACETATE
JHP PHARMS
* JHP PHARMACEUTICALS LLC
ADRENALIN, EPINEPHRINE
BREVITAL SODIUM, METHOHEXITAL SODIUM
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
DANTRIUM, DANTROLENE SODIUM
DELESTROGEN, ESTRADIOL VALERATE
KETALAR, KETAMINE HYDROCHLORIDE
PITOCIN, OXYTOCIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIOSTAT, LIOTHYRONINE SODIUM
JHP PHARMS LLC
* JHP PHARMACEUTICALS LLC
ADRENALIN, EPINEPHRINE
ETOMIDATE, ETOMIDATE
JIANGSU HANSOH PHARM
* JIANGSU HANSOH PHARMACEUTICAL CO LTD
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
JIANGSU HENGRUI MED
* JIANGSU HENGRUI MEDICINE CO LTD
B - 59
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
J
**
* JIANGSU HENGRUI MEDICINE CO LTD
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
JOHNSON AND JOHNSON
* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MEN'S ROGAINE, MINOXIDIL
(OTC)
ROGAINE (FOR MEN), MINOXIDIL
(OTC)
ROGAINE (FOR WOMEN), MINOXIDIL
(OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL
(OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE
(OTC)
* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE
(OTC)
JUBILANT CADISTA
* JUBILANT CADISTA PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
PREDNISONE, PREDNISONE
PROCOMP, PROCHLORPERAZINE MALEATE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
JUBILANT DRAXIMAGE
* JUBILANT DRAXIMAGE INC
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
HICON, SODIUM IODIDE I-131
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
SODIUM IODIDE I-131, SODIUM IODIDE I-131
JUBILANT LIFE
* JUBILANT LIFE SCIENCES LTD
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
JUBILANT ORGANOSYS
* JUBILANT ORGANOSYS LTD
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
OLANZAPINE, OLANZAPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
RISPERIDONE, RISPERIDONE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
STEVENS J
* JEROME STEVENS PHARMACEUTICALS INC
DIGOXIN, DIGOXIN
METHOCARBAMOL AND ASPIRIN, ASPIRIN
UNITHROID, LEVOTHYROXINE SODIUM **
**
K
**
KING PFIZER
* KING PHARMACEUTICALS INC SUB PFIZER INC
AVINZA, MORPHINE SULFATE
KING PHARMS
* KING PHARMACEUTICALS INC
ALTACE, RAMIPRIL
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
CORGARD, NADOLOL
CORZIDE, BENDROFLUMETHIAZIDE
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
SKELAXIN, METAXALONE
SYNERCID, DALFOPRISTIN
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
B - 60
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
K
**
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
TAPAZOLE, METHIMAZOLE
TUSSIGON, HOMATROPINE METHYLBROMIDE
KING PHARMS R AND D
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC
CYTOMEL, LIOTHYRONINE SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM **
* KING PHARMACEUTICALS RESEARCH DEVELOPMENT INC
OXECTA, OXYCODONE HYDROCHLORIDE
KOWA CO
* KOWA CO LTD
LIVALO, PITAVASTATIN CALCIUM
KREITCHMAN PET CTR
* KREITCHMAN PET CENTER
AMMONIA N 13, AMMONIA N-13
KREMERS URBAN DEV
* KREMERS URBAN DEVELOPMENT CO
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
KREMERS URBAN PHARMS
* KREMERS URBAN PHARMACEUTICALS INC
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOLAX, POLYETHYLENE GLYCOL 3350
(OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
MONOKET, ISOSORBIDE MONONITRATE
NITROGLYCERIN, NITROGLYCERIN
OMEPRAZOLE, OMEPRAZOLE
KRKA TOVARNA ZDRAVIL
* KRKA TOVARNA ZDRAVIL DD NOVO MESTO
LANSOPRAZOLE , LANSOPRAZOLE
KUDCO IRELAND
* KUDCO IRELAND LTD
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
LETROZOLE, LETROZOLE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
KV PHARM
* KV PHARMACEUTICAL CO
CLINDESSE, CLINDAMYCIN PHOSPHATE
EVAMIST, ESTRADIOL
MAKENA, HYDROXYPROGESTERONE CAPROATE
KVK TECH
* KVK TECH INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KALEXATE, SODIUM POLYSTYRENE SULFONATE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
**
L
**
LAB HRA PHARMA
* LABORATOIRE HRA PHARMA
ELLA, ULIPRISTAL ACETATE
LANDELA PHARM
* LANDELA PHARMACEUTICAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LANNETT
* LANNETT CO INC
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
B - 61
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
L
**
* LANNETT CO INC
LANIAZID, ISONIAZID
LANORINAL, ASPIRIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
* LANNETT HOLDINGS INC
BACLOFEN, BACLOFEN
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
DANAZOL, DANAZOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
TERBUTALINE SULFATE, TERBUTALINE SULFATE
URSODIOL, URSODIOL
LANNETT HOLDINGS INC
* LANNETT HOLDINGS INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
METHOCARBAMOL, METHOCARBAMOL
MORPHINE SULFATE, MORPHINE SULFATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LANTHEUS MEDCL
* LANTHEUS MEDICAL IMAGING INC
ABLAVAR, GADOFOSVESET TRISODIUM
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
XENON XE 133, XENON XE-133
LANTHEUS MEDICAL
* LANTHEUS MEDICAL IMAGING INC
QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
LARKEN LABS
* LARKEN LABORATORIES INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
LAVIPHARM LABS
* LAVIPHARM LABORATORIES INC
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
LEHIGH VALLEY
* LEHIGH VALLEY TECHNOLOGIES INC
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
LEK PHARMS DD
* LEK PHARMACEUTICALS DD
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
LEO PHARM
* LEO PHARMACEUTICAL PRODUCTS LTD
DOVONEX, CALCIPOTRIENE
LEO PHARMA AS
B - 62
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
L
**
* LEO PHARMA AS
DOVONEX, CALCIPOTRIENE
PICATO, INGENOL MEBUTATE
TACLONEX, BETAMETHASONE DIPROPIONATE
LG LIFE
* LG LIFE SCIENCES LTD
VALTROPIN, SOMATROPIN RECOMBINANT
LG LIFE SCIENCES
* LG LIFE SCIENCES LTD
FACTIVE, GEMIFLOXACIN MESYLATE
LIAONING CHENGDA
* LIAONING CHENGDA BIOTECHNOLOGY CO LTD
ZIDOVUDINE, ZIDOVUDINE
LLOYD
* LLOYD INC
LEVOTHROID, LEVOTHYROXINE SODIUM **
LNK
* LNK INTERNATIONAL INC
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE
(OTC)
IBUPROFEN, IBUPROFEN
(OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
(OTC)
LOREAL USA
* LOREAL USA PRODUCTS INC
ANTHELIOS 20, AVOBENZONE
(OTC)
ANTHELIOS 40, AVOBENZONE
(OTC)
ANTHELIOS SX, AVOBENZONE
(OTC)
CAPITAL SOLEIL 15, AVOBENZONE
(OTC)
LOTUS PHARM CO LTD
* LOTUS PHARMACEUTICAL CO LTD
LEVETIRACETAM, LEVETIRACETAM
LUITPOLD
* LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE, ACETYLCYSTEINE
ADENOSINE, ADENOSINE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BROMFENAC SODIUM, BROMFENAC SODIUM
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CYANOCOBALAMIN, CYANOCOBALAMIN
CYCLOSPORINE, CYCLOSPORINE
DACTINOMYCIN, DACTINOMYCIN
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
ESTRADIOL VALERATE, ESTRADIOL VALERATE
ETOMIDATE, ETOMIDATE
FOMEPIZOLE, FOMEPIZOLE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GANCICLOVIR, GANCICLOVIR SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
INJECTAFER, FERRIC CARBOXYMALTOSE
LATANOPROST, LATANOPROST
LEVETIRACETAM, LEVETIRACETAM
LEVOCARNITINE, LEVOCARNITINE
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
B - 63
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
L
**
* LUITPOLD PHARMACEUTICALS INC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NITROGLYCERIN, NITROGLYCERIN
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROGESTERONE, PROGESTERONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SPRIX, KETOROLAC TROMETHAMINE
TORSEMIDE, TORSEMIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
VENOFER, IRON SUCROSE
ZIDOVUDINE, ZIDOVUDINE
LUKARE MEDICAL LLC
* LUKARE MEDICAL LLC
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
LUNDBECK LLC
* LUNDBECK LLC
ONFI, CLOBAZAM
SABRIL, VIGABATRIN
LUPIN
* LUPIN LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOVASTATIN, LOVASTATIN
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
LUPIN ATLANTIS
* LUPIN ATLANTIS HOLDINGS SA
ANTARA (MICRONIZED), FENOFIBRATE
LUPIN LTD
* LUPIN LIMITED
LEVETIRACETAM, LEVETIRACETAM
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
* LUPIN LTD
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE
DAYSEE, ETHINYL ESTRADIOL
DOXYCYCLINE, DOXYCYCLINE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENSKYCE, DESOGESTREL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FAMOTIDINE, FAMOTIDINE
B - 64
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
L
**
* LUPIN LTD
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
GATIFLOXACIN, GATIFLOXACIN
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
JENCYCLA, NORETHINDRONE
KURVELO, ETHINYL ESTRADIOL
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL
(OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFENAMIC ACID, MEFENAMIC ACID
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NABUMETONE, NABUMETONE
NORETHINDRONE, NORETHINDRONE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PIRMELLA 1/35, ETHINYL ESTRADIOL
PIRMELLA 7/7/7, ETHINYL ESTRADIOL
PREGABALIN, PREGABALIN
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RANOLAZINE, RANOLAZINE
SUPRAX, CEFIXIME
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VYFEMLA, ETHINYL ESTRADIOL
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
LUPIN PHARMS
* LUPIN PHARMACEUTICALS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
DESLORATADINE, DESLORATADINE
MELOXICAM, MELOXICAM
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RIFAMPIN, RIFAMPIN
SUPRAX, CEFIXIME
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
LYNE
* LYNE LABORATORIES INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
HYDROCORTISONE, HYDROCORTISONE
LEVOCARNITINE, LEVOCARNITINE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
LYNROSE LABS
* LYNROSE LABS LLC
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
PERRIGO
* L PERRIGO CO
ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN
(OTC)
CROMOLYN SODIUM, CROMOLYN SODIUM
(OTC)
FAMOTIDINE, FAMOTIDINE
(OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN
(OTC)
B - 65
B - 66
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
L
**
* L PERRIGO CO
IBUPROFEN, IBUPROFEN
(OTC)
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE
LORATADINE, LORATADINE
(OTC)
MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE
(OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL
(OTC)
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
TIOCONAZOLE, TIOCONAZOLE
(OTC)
**
M
**
MACLEODS PHARMS LTD
* MACLEODS PHARMACEUTICALS LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FAMCICLOVIR, FAMCICLOVIR
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LEVOFLOXACIN, LEVOFLOXACIN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MALLINCKRODT
* MALLINCKRODT CHEMICAL INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
METHADOSE, METHADONE HYDROCHLORIDE
* MALLINCKRODT INC
ANEXSIA 5/325, ACETAMINOPHEN
ANEXSIA 7.5/325, ACETAMINOPHEN
ANEXSIA, ACETAMINOPHEN
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PENNSAID, DICLOFENAC SODIUM
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* MALLINCKRODT MEDICAL INC
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OPTIRAY 300, IOVERSOL
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SODIUM IODIDE I 131, SODIUM IODIDE I-131
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
MALLINCKRODT INC
* MALLINCKRODT INC
(OTC)
(OTC)
B - 67
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE,
EXALGO, HYDROMORPHONE HYDROCHLORIDE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
GABLOFEN, BACLOFEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
RESTORIL, TEMAZEPAM
ROXICODONE, OXYCODONE HYDROCHLORIDE
TOFRANIL, IMIPRAMINE HYDROCHLORIDE
TOFRANIL-PM, IMIPRAMINE PAMOATE
MALLINCKRODT LLC
* MALLINCKRODT LLC
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
MARATHON PHARMS
* MARATHON PHARMACEUTICALS LLC
PEPCID, FAMOTIDINE
SECONAL SODIUM, SECOBARBITAL SODIUM
MARATHON PHARMS LLC
* MARATHON PHARMACEUTICALS LLC
IPRIVASK, DESIRUDIN RECOMBINANT
MARKSANS PHARMA
* MARKSANS PHARMA LTD
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
NAPROXEN, NAPROXEN
MATRIX LABS LTD
* MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
NIFEDIPINE, NIFEDIPINE
STAVUDINE, STAVUDINE
MAYNE PHARMA
* MAYNE PHARMA INTERNATIONAL PTY LTD
DORYX, DOXYCYCLINE HYCLATE
ERYC, ERYTHROMYCIN
MCNEIL
* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE
(OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE
(OTC)
MOTRIN IB, IBUPROFEN
(OTC)
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE
(OTC)
MCNEIL CONS
* MCNEIL CONSUMER HEALTHCARE
CHILDREN'S MOTRIN COLD, IBUPROFEN
(OTC)
CHILDREN'S MOTRIN, IBUPROFEN
(OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE
(OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE
(OTC)
IMODIUM, LOPERAMIDE HYDROCHLORIDE
JUNIOR STRENGTH MOTRIN, IBUPROFEN
(OTC)
NIZORAL A-D, KETOCONAZOLE
(OTC)
PEPCID AC , FAMOTIDINE
(OTC)
AMPHETAMINE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MCNEIL CONSUMER HEALTHCARE
PEPCID AC, FAMOTIDINE
(OTC)
PEPCID COMPLETE, CALCIUM CARBONATE
(OTC)
SINE-AID IB, IBUPROFEN
(OTC)
SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE
(OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE
(OTC)
TYLENOL , ACETAMINOPHEN
(OTC)
MCNEIL CONSUMER
* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
ZYRTEC, CETIRIZINE HYDROCHLORIDE
MCPRF
* MAYO CLINIC PET RADIOCHEMISTRY FACILITY
AMMONIA N 13, AMMONIA N-13
CHOLINE C-11, CHOLINE C-11
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
MEDA PHARMS
* MEDA PHARMACEUTICALS
DYMISTA, AZELASTINE HYDROCHLORIDE
EDLUAR, ZOLPIDEM TARTRATE
* MEDA PHARMACEUTICALS INC
ANADROL-50, OXYMETHOLONE
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
AVC, SULFANILAMIDE
BUTISOL SODIUM, BUTABARBITAL SODIUM
CESAMET, NABILONE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
CORTIFOAM, HYDROCORTISONE ACETATE
DEMADEX, TORSEMIDE
DEPEN, PENICILLAMINE
DIPENTUM, OLSALAZINE SODIUM
ELESTRIN, ESTRADIOL
EPIFOAM, HYDROCORTISONE ACETATE
FELBATOL, FELBAMATE
GASTROCROM, CROMOLYN SODIUM
LUFYLLIN, DYPHYLLINE
MUSE, ALPROSTADIL
OPTIVAR, AZELASTINE HYDROCHLORIDE
PROCTOFOAM HC, HYDROCORTISONE ACETATE
ROWASA, MESALAMINE
SFROWASA, MESALAMINE
TRILYTE, POLYETHYLENE GLYCOL 3350
* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN
SOMA, CARISOPRODOL
MEDEFIL INC
* MEDEFIL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
MEDICIS
* MEDICIS PHARMACEUTICAL CORP
ALDARA, IMIQUIMOD
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DYNACIN, MINOCYCLINE HYDROCHLORIDE
ESTRASORB, ESTRADIOL HEMIHYDRATE
LOPROX, CICLOPIROX
LUZU, LULICONAZOLE
B - 68
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
* MEDICIS PHARMACEUTICAL CORP
MAXAIR, PIRBUTEROL ACETATE
METROGEL-VAGINAL, METRONIDAZOLE
MINITRAN, NITROGLYCERIN
NORFLEX, ORPHENADRINE CITRATE
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN
SOLODYN, MINOCYCLINE HYDROCHLORIDE
THEOLAIR, THEOPHYLLINE
VANOS, FLUOCINONIDE
ZIANA, CLINDAMYCIN PHOSPHATE
ZYCLARA, IMIQUIMOD
MEDICURE
* MEDICURE INTERNATIONAL INC
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
MEDIGENE AG
* MEDIGENE AG
VEREGEN, SINECATECHINS
MEDIMETRIKS PHARMS
* MEDIMETRIKS PHARMACEUTICALS INC
LOPROX, CICLOPIROX
SYNALAR, FLUOCINOLONE ACETONIDE
MEDIMMUNE
* MEDIMMUNE
ETHYOL, AMIFOSTINE
MEDTECH PRODS
* MEDTECH PRODUCTS INC
TAGAMET HB, CIMETIDINE
(OTC)
MEDTRONIC NEURO
* MEDTRONIC NEUROMODULATION
LIORESAL, BACLOFEN
MERCK
* MERCK AND CO INC
CANCIDAS, CASPOFUNGIN ACETATE
EMEND, APREPITANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
PRIMAXIN, CILASTATIN SODIUM
PROSCAR, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
ZOLINZA, VORINOSTAT
* MERCK RESEARCH LABORATORIES DIV MERCK CO INC
PROPECIA, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE
ZOCOR, SIMVASTATIN
MERCK AND CO INC
* MERCK AND CO INC
EMEND, FOSAPREPITANT DIMEGLUMINE
FOSAMAX, ALENDRONATE SODIUM
MERCK SANTE SAS
* MERCK SANTE SAS
CYANOKIT, HYDROXOCOBALAMIN
MERCK SHARP DOHME
* MERCK SHARP AND DOHME CORP
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX, DESLORATADINE
CLARINEX-D 12 HOUR, DESLORATADINE
COZAAR, LOSARTAN POTASSIUM
CRIXIVAN, INDINAVIR SULFATE
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
**
B - 69
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MERCK SHARP AND DOHME CORP
DIPROLENE, BETAMETHASONE DIPROPIONATE
DULERA, FORMOTEROL FUMARATE
ELOCON, MOMETASONE FUROATE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
HYZAAR, HYDROCHLOROTHIAZIDE
INVANZ, ERTAPENEM SODIUM
ISENTRESS, RALTEGRAVIR POTASSIUM
JANUMET XR, METFORMIN HYDROCHLORIDE
JANUMET, METFORMIN HYDROCHLORIDE
JANUVIA, SITAGLIPTIN PHOSPHATE
LIPTRUZET, ATORVASTATIN CALCIUM
LOTRISONE, BETAMETHASONE DIPROPIONATE
NITRO-DUR, NITROGLYCERIN
NOXAFIL, POSACONAZOLE
REBETOL, RIBAVIRIN
SINEMET CR, CARBIDOPA
SINEMET, CARBIDOPA
STROMECTOL, IVERMECTIN
TEMODAR, TEMOZOLOMIDE
VICTRELIS, BOCEPREVIR
ZIOPTAN, TAFLUPROST
MERIDIAN MEDCL
* MERIDIAN MEDICAL TECHNOLOGIES INC
DUODOTE, ATROPINE
* MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC
ALSUMA, SUMATRIPTAN SUCCINATE
MERIDIAN MEDCL TECHN
* MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPEN, ATROPINE
MERRO PHARM
* MERRO PHARMACEUTICAL CO LTD
IBUPROFEN, IBUPROFEN
(OTC)
MERZ PHARMS
* MERZ PHARMACEUTICALS LLC
CUVPOSA, GLYCOPYRROLATE
NAFTIN, NAFTIFINE HYDROCHLORIDE
ONMEL, ITRACONAZOLE
METHAPHARM
* METHAPHARM INC
LEVETIRACETAM, LEVETIRACETAM
PROVOCHOLINE, METHACHOLINE CHLORIDE
MICRO LABS LTD
* MICRO LABS LTD
MEFENAMIC ACID, MEFENAMIC ACID
NEVIRAPINE, NEVIRAPINE
SIMVASTATIN, SIMVASTATIN
MICRO LABS LTD INDIA
* MICRO LABS LTD INDIA
CROMOLYN SODIUM, CROMOLYN SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
MIKAH PHARMA
* MIKAH PHARMA LLC
DANTROLENE SODIUM, DANTROLENE SODIUM
ISRADIPINE, ISRADIPINE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
MIKART
* MIKART INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMINOCAPROIC, AMINOCAPROIC ACID
B - 70
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MIKART INC
BENZONATATE, BENZONATATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTAPAP, ACETAMINOPHEN
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CHLORZOXAZONE, CHLORZOXAZONE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ESGIC-PLUS, ACETAMINOPHEN
ETHOSUXIMIDE, ETHOSUXIMIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
MILLENNIUM PHARMS
* MILLENNIUM PHARMACEUTICALS INC
VELCADE, BORTEZOMIB
MIRROR PHARMS
* MIRROR PHARMACEUTICALS LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CARISOPRODOL, CARISOPRODOL
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROBENECID AND COLCHICINE, COLCHICINE
MISSION PHARMA
* MISSION PHARMACAL CO
BINOSTO, ALENDRONATE SODIUM
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
TEXACORT, HYDROCORTISONE
THIOLA, TIOPRONIN
TINDAMAX, TINIDAZOLE
UROCIT-K, POTASSIUM CITRATE
MIST PHARMS LLC
* MIST PHARMACEUTICALS LLC
NITROMIST, NITROGLYCERIN
MN PHARMS
* MN PHARMACEUTICALS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
MOBIUS THERAP
* MOBIUS THERAPEUTICS LLC
MITOSOL, MITOMYCIN
MOLNLYCKE HLTH
* MOLNLYCKE HEALTH CARE
HIBICLENS, CHLORHEXIDINE GLUCONATE
(OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE
(OTC)
MONARCH PHARMS
* MONARCH PHARMACEUTICALS INC
MENEST, ESTROGENS, ESTERIFIED
NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE
MSD CONSUMER
* MSD CONSUMER CARE INC
OXYTROL FOR WOMEN, OXYBUTYNIN
(OTC)
ZEGERID OTC, OMEPRAZOLE
(OTC)
MSD INTL
* MSD INTERNATIONAL GMBH
VYTORIN, EZETIMIBE
MSD INTL GMBH
* MSD INTERNATIONAL GMBH
ZETIA, EZETIMIBE
MURTY PHARMS
B - 71
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 72
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MURTY PHARMACEUTICALS INC
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
MUSTAFA NEVSAT
* MUSTAFA NEVSAT ILAC SANAYII AS
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
MUSTAFA NEVZAT
* MUSTAFA NEVZAT ILAC SANAYII AS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE
MUTUAL PHARM
* MUTUAL PHARMACEUTICAL CO INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BACTRIM DS, SULFAMETHOXAZOLE
BACTRIM, SULFAMETHOXAZOLE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
FELODIPINE, FELODIPINE
LOVASTATIN, LOVASTATIN
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
SPIRONOLACTONE, SPIRONOLACTONE
TEMAZEPAM, TEMAZEPAM
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
MUTUAL PHARM CO INC
* MUTUAL PHARMACEUTICAL CO INC
FIBRICOR, FENOFIBRIC ACID
IBANDRONATE SODIUM, IBANDRONATE SODIUM
LEVETIRACETAM, LEVETIRACETAM
QUALAQUIN, QUININE SULFATE
MUTUAL PHARMA
* MUTUAL PHARMACAL CO
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
MYLAN
* MYLAN LABORATORIES INC
ACYCLOVIR, ACYCLOVIR
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
* MYLAN PHARMACEUTICALS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
* MYLAN PHARMACEUTICALS INC
ACARBOSE, ACARBOSE
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MYLAN PHARMACEUTICALS INC
ATENOLOL, ATENOLOL
AVITA, TRETINOIN
AZATHIOPRINE, AZATHIOPRINE
AZITHROMYCIN, AZITHROMYCIN
BACLOFEN, BACLOFEN
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CILOSTAZOL, CILOSTAZOL
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLORPRES, CHLORTHALIDONE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DIAZEPAM, DIAZEPAM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ESTROPIPATE, ESTROPIPATE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETOPOSIDE, ETOPOSIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
(OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
B - 73
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 74
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MYLAN PHARMACEUTICALS INC
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMOTRIGINE, LAMOTRIGINE
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LORATADINE, LORATADINE
(OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE
MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM
MELOXICAM, MELOXICAM
MENTAX, BUTENAFINE HYDROCHLORIDE
MENTAX-TC, BUTENAFINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHYLDOPA, METHYLDOPA
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIRTAZAPINE, MIRTAZAPINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE
NIFEDIPINE, NIFEDIPINE
NISOLDIPINE, NISOLDIPINE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PACLITAXEL, PACLITAXEL
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
PHENYTEK, PHENYTOIN SODIUM
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MYLAN PHARMACEUTICALS INC
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
STAVUDINE, STAVUDINE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TACROLIMUS, TACROLIMUS
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TEMAZEPAM, TEMAZEPAM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
MYLAN INSTITUTIONAL
* MYLAN INSTITUTIONAL INC
SULFAMYLON, MAFENIDE ACETATE
* MYLAN INSTITUTIONAL LLC
ALOPRIM, ALLOPURINOL SODIUM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CARBOPLATIN, CARBOPLATIN
CIDOFOVIR, CIDOFOVIR
COSYNTROPIN, COSYNTROPIN
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DURACLON, CLONIDINE HYDROCHLORIDE
ENLON, EDROPHONIUM CHLORIDE
ENLON-PLUS, ATROPINE SULFATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FOMEPIZOLE, FOMEPIZOLE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISOSULFAN BLUE, ISOSULFAN BLUE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MESNA, MESNA
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
RIMSO-50, DIMETHYL SULFOXIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
B - 75
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MYLAN INSTITUTIONAL LLC
SOTRADECOL, SODIUM TETRADECYL SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
ULTIVA, REMIFENTANIL HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
MYLAN LABS
* MYLAN LABORATORIES LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
NEVIRAPINE, NEVIRAPINE
MYLAN PHARMS INC
* MYLAN PHARMACEUTICALS INC
ABACAVIR SULFATE, ABACAVIR SULFATE
ACYCLOVIR, ACYCLOVIR
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
AMNESTEEM, ISOTRETINOIN
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ARMODAFINIL, ARMODAFINIL
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AVITA, TRETINOIN
BACLOFEN, BACLOFEN
CABERGOLINE, CABERGOLINE
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DESLORATADINE, DESLORATADINE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIDANOSINE, DIDANOSINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENTACAPONE, ENTACAPONE
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
ESZOPICLONE, ESZOPICLONE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FINASTERIDE, FINASTERIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
INDAPAMIDE, INDAPAMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ITRACONAZOLE, ITRACONAZOLE
LANSOPRAZOLE, LANSOPRAZOLE
LEVETIRACETAM, LEVETIRACETAM
LITHIUM CARBONATE, LITHIUM CARBONATE
MALATHION, MALATHION
B - 76
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
* MYLAN PHARMACEUTICALS INC
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MODAFINIL, MODAFINIL
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NEVIRAPINE, NEVIRAPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
PINDOLOL, PINDOLOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUININE SULFATE, QUININE SULFATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RAMIPRIL, RAMIPRIL
REPAGLINIDE, REPAGLINIDE
RILUZOLE, RILUZOLE
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SIMVASTATIN, SIMVASTATIN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAZOLAM, TRIAZOLAM
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VORICONAZOLE, VORICONAZOLE
ZIDOVUDINE, ZIDOVUDINE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
ZONISAMIDE, ZONISAMIDE
* MYLAN PHARMACEUTICALS INC.
FLUVASTATIN SODIUM, FLUVASTATIN SODIUM
NIZATIDINE, NIZATIDINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
MYLAN SPECLT
* MYLAN SPECIALTY LP
ALBUTEROL SULFATE, ALBUTEROL SULFATE
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
PERFOROMIST, FORMOTEROL FUMARATE
MYLAN TECHNOLOGIES
* MYLAN TECHNOLOGIES INC
CLONIDINE, CLONIDINE
B - 77
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
M
**
**
N
**
* MYLAN TECHNOLOGIES INC
ESTRADIOL, ESTRADIOL
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
NITROGLYCERIN, NITROGLYCERIN
NATCO PHARMA
* NATCO PHARMA LTD
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
NATCO PHARMA LTD
* NATCO PHARMA LIMITED
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
* NATCO PHARMA LTD
ANASTROZOLE, ANASTROZOLE
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
LANSOPRAZOLE, LANSOPRAZOLE
LETROZOLE, LETROZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
NAUTILUS NEUROSCIENC
* NAUTILUS NEUROSCIENCES INC
CAMBIA, DICLOFENAC POTASSIUM
NAVIDEA BIOPHARMS
* NAVIDEA BIOPHARMACEUTICALS INC
LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT
NAVINTA LLC
* NAVINTA LLC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
FAMOTIDINE, FAMOTIDINE
FOMEPIZOLE, FOMEPIZOLE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NEPHRON
* NEPHRON CORP
ALBUTEROL SULFATE, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
* NEPHRON PHARMACEUTICALS CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
NESHER PHARMS
* NESHER PHARMACEUTICALS USA LLC
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
MICRO-K 10, POTASSIUM CHLORIDE
MICRO-K, POTASSIUM CHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
NEXGEN PHARMA
* NEXGEN PHARMA INC
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHENODIOL, CHENODIOL
GLYCOPYRROLATE, GLYCOPYRROLATE
MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
NEXGEN PHARMA INC
* NEXGEN PHARMA INC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
B - 78
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
N
**
NEXTWAVE PHARMS
* NEXTWAVE PHARMACEUTICALS INC
QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE
NEXUS PHARMS
* NEXUS PHARMACEUTICALS INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
LEVOFLOXACIN, LEVOFLOXACIN
NIAGARA PHARMS
* NIAGARA PHARMACEUTICALS INC
PUR-WASH, PURIFIED WATER
(OTC)
NORTHSTAR HLTHCARE
* NORTHSTAR HEALTHCARE HOLDINGS LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
GEMFIBROZIL, GEMFIBROZIL
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
NOSTRUM
* NOSTRUM PHARMACEUTICALS INC
CARBAMAZEPINE, CARBAMAZEPINE
THEOPHYLLINE, THEOPHYLLINE
NOSTRUM LABS
* NOSTRUM LABORATORIES INC
PIROXICAM, PIROXICAM
SUCRALFATE, SUCRALFATE
NOSTRUM PHARMS LLC
* NOSTRUM PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NOVADEL
* NOVADEL PHARMA INC
ZOLPIMIST, ZOLPIDEM TARTRATE
NOVARTIS
* NOVARTIS CONSUMER HEALTH INC
EXCEDRIN (MIGRAINE), ACETAMINOPHEN
(OTC)
HABITROL, NICOTINE
(OTC)
LAMISIL AT, TERBINAFINE
(OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE
(OTC)
NEXCEDE, KETOPROFEN
(OTC)
PREVACID 24 HR, LANSOPRAZOLE
(OTC)
TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN
(OTC)
THRIVE, NICOTINE POLACRILEX
(OTC)
VAGISTAT-1, TIOCONAZOLE
(OTC)
VOLTAREN, DICLOFENAC SODIUM
* NOVARTIS PHARMACEUTICALS CORP
AFINITOR, EVEROLIMUS
AMTURNIDE, ALISKIREN HEMIFUMARATE
ARCAPTA NEOHALER, INDACATEROL MALEATE
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
COMBIPATCH, ESTRADIOL
DESFERAL, DEFEROXAMINE MESYLATE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
ESTRADERM, ESTRADIOL
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXFORGE HCT, AMLODIPINE BESYLATE
EXFORGE, AMLODIPINE BESYLATE
EXJADE, DEFERASIROX
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
B - 79
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
N
**
* NOVARTIS PHARMACEUTICALS CORP
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FORADIL, FORMOTEROL FUMARATE
GILENYA, FINGOLIMOD
GLEEVEC, IMATINIB MESYLATE
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMPRENE, CLOFAZIMINE
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LOTREL, AMLODIPINE BESYLATE
MIACALCIN, CALCITONIN SALMON
MYFORTIC, MYCOPHENOLIC ACID
NEORAL, CYCLOSPORINE
RECLAST, ZOLEDRONIC ACID
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
SIGNIFOR, PASIREOTIDE DIASPARTATE
STARLIX, NATEGLINIDE
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TEGRETOL-XR, CARBAMAZEPINE
TEKAMLO, ALISKIREN HEMIFUMARATE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TOBI PODHALER, TOBRAMYCIN
TRILEPTAL, OXCARBAZEPINE
TYZEKA, TELBIVUDINE
VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VOLTAREN, DICLOFENAC SODIUM
ZOMETA, ZOLEDRONIC ACID
ZORTRESS, EVEROLIMUS
NOVARTIS PHARM
* NOVARTIS PHARMACEUTICAL CORP
AFINITOR DISPERZ, EVEROLIMUS
NOVARTIS PHARMS
* NOVARTIS PHARMACEUTICALS CORP
FEMARA, LETROZOLE
TOBI, TOBRAMYCIN
NOVAST LABS
* NOVAST LABORATORIES CHINA LTD
NORETHINDRONE, NORETHINDRONE
NOVAST LABS LTD
* NOVAST LABORATORIES LTD
DASETTA 1/35, ETHINYL ESTRADIOL
DASETTA 7/7/7, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
ELINEST, ETHINYL ESTRADIOL
FALMINA, ETHINYL ESTRADIOL
LARIN 1/20, ETHINYL ESTRADIOL
LARIN FE 1.5/30, ETHINYL ESTRADIOL
LARIN FE 1/20, ETHINYL ESTRADIOL
LEVONEST, ETHINYL ESTRADIOL
MONO-LINYAH, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
PHILITH, ETHINYL ESTRADIOL
PIMTREA, DESOGESTREL
TRI-LINYAH, ETHINYL ESTRADIOL
WERA, ETHINYL ESTRADIOL
NOVEL LABS INC
* NOVEL LABORATORIES INC
FAMOTIDINE, FAMOTIDINE
B - 80
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 81
PRODUCT NAME SORTED BY APPLICANT
**
N
**
* NOVEL LABORATORIES INC
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL
(OTC)
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
MISOPROSTOL, MISOPROSTOL
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL
PHENELZINE SULFATE, PHENELZINE SULFATE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
TEMAZEPAM, TEMAZEPAM
TINIDAZOLE, TINIDAZOLE
TRIMETHOPRIM, TRIMETHOPRIM
NOVEN
* NOVEN PHARMACEUTICALS INC
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
MINIVELLE, ESTRADIOL
NOVEN PHARMS INC
* NOVEN PHARMACEUTICALS INC
DAYTRANA, METHYLPHENIDATE
NOVEN THERAP
* NOVEN THERAPEUTICS LLC
BRISDELLE, PAROXETINE MESYLATE
LITHOBID, LITHIUM CARBONATE
PEXEVA, PAROXETINE MESYLATE
NOVEX
* NOVEX PHARMA
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
NOVO NORDISK INC
* NOVO NORDISK INC
ACTIVELLA, ESTRADIOL
LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT
LEVEMIR, INSULIN DETEMIR RECOMBINANT
NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
(OTC)
NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT
NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
VAGIFEM, ESTRADIOL
VICTOZA, LIRAGLUTIDE RECOMBINANT
NOVOCOL
* NOVOCOL PHARMACEUTICAL INC
ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
NOVOCOL INC
* NOVOCOL INC
LIDOCAINE, LIDOCAINE
NPS PHARMS INC
* NPS PHARMACEUTICALS INC
GATTEX KIT, TEDUGLUTIDE RECOMBINANT
NU PHARM
* NU PHARM INC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
NUPATHE
* NUPATHE INC
ZECUITY, SUMATRIPTAN SUCCINATE
NYCOMED US
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
N
**
**
O
**
* NYCOMED US INC
TERCONAZOLE, TERCONAZOLE
OAK PHARMS
* OAK PHARMACEUTICALS INC
EMLA, LIDOCAINE
NEMBUTAL SODIUM, PENTOBARBITAL SODIUM
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
OAK PHARMS AKORN
* OAK PHARMACEUTICALS INC SUB AKORN INC
COGENTIN, BENZTROPINE MESYLATE
DIURIL, CHLOROTHIAZIDE SODIUM
* OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
AZASITE, AZITHROMYCIN
COSOPT PF, DORZOLAMIDE HYDROCHLORIDE
COSOPT, DORZOLAMIDE HYDROCHLORIDE
ODYSSEY PHARMS
* ODYSSEY PHARMACEUTICALS INC
ANTABUSE, DISULFIRAM
NYSTATIN, NYSTATIN
SURMONTIL, TRIMIPRAMINE MALEATE
URECHOLINE, BETHANECHOL CHLORIDE
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
OHM LABS
* OHM LABORATORIES INC
ACETAMINOPHEN, ACETAMINOPHEN
(OTC)
IBUPROHM COLD AND SINUS, IBUPROFEN
(OTC)
OLTA PHARMS
* OLTA PHARMACEUTICALS CORP
LINDANE, LINDANE
OMAN PHARM PRODUCTS
* OMAN PHARMACEUTICAL PRODUCTS CO LLC
NEOMYCIN SULFATE, NEOMYCIN SULFATE
ONCO THERAPIES LTD
* ONCO THERAPIES LTD
CARBOPLATIN, CARBOPLATIN
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CYTARABINE, CYTARABINE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VINORELBINE, VINORELBINE
ONYX PHARMS
* ONYX PHARMACEUTICALS INC
KYPROLIS, CARFILZOMIB
OPTIMER PHARMS
* OPTIMER PHARMACEUTICALS INC
DIFICID, FIDAXOMICIN
ORAPHARMA
* ORAPHARMA INC
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ORCHID HLTHCARE
* ORCHID HEALTHCARE
B - 82
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
O
**
* ORCHID HEALTHCARE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
MODAFINIL, MODAFINIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZALEPLON, ZALEPLON
OREXO AB
* OREXO AB
ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE
ORGANON SUB MERCK
* ORGANON USA INC SUB MERCK AND CO INC
SAPHRIS, ASENAPINE MALEATE
ORGANON USA INC
* ORGANON USA INC
CYCLESSA, DESOGESTREL
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
GANIRELIX ACETATE, GANIRELIX ACETATE
IMPLANON, ETONOGESTREL
NEXPLANON, ETONOGESTREL
NUVARING, ETHINYL ESTRADIOL
REMERON SOLTAB, MIRTAZAPINE
ZEMURON, ROCURONIUM BROMIDE
ORION PHARMA
* ORION PHARMA
COMTAN, ENTACAPONE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
ORIT LABS LLC
* ORIT LABORATORIES LLC
BENZONATATE, BENZONATATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ERGOCALCIFEROL, ERGOCALCIFEROL
LEVETIRACETAM, LEVETIRACETAM
ORPHAN EUROPE
* ORPHAN EUROPE
CARBAGLU, CARGLUMIC ACID
ORTHO MCNEIL JANSSEN
* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
NIZORAL, KETOCONAZOLE
OSI PHARMS
* OSI PHARMACEUTICALS INC
TARCEVA, ERLOTINIB HYDROCHLORIDE
OSMOTICA PHARM
B - 83
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
O
**
* OSMOTICA PHARMACEUTICAL CORP
NIFEDIPINE, NIFEDIPINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
OSMOTICA PHARM CORP
* OSMOTICA PHARMACEUTICAL CORP
KHEDEZLA, DESVENLAFAXINE
OTSUKA
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY, ARIPIPRAZOLE
PLETAL, CILOSTAZOL
* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC
ABILIFY, ARIPIPRAZOLE
OTSUKA AMERICA
* OTSUKA AMERICA PHARMACEUTICALS INC
BREATHTEK UBT FOR H-PYLORI, UREA C-13
OTSUKA AMERICA PHARM
* OTSUKA AMERICA PHARMACEUTICAL INC
SAMSCA, TOLVAPTAN
OTSUKA PHARM
* OTSUKA PHARMACEUTICAL CO LTD
BUSULFEX, BUSULFAN
OTSUKA PHARM CO LTD
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY MAINTENA KIT, ARIPIPRAZOLE
OUTLOOK PHARMS
* OUTLOOK PHARMACEUTICALS INC
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
**
P
**
PACIRA PHARMS INC
* PACIRA PHARMACEUTICALS INC
DEPOCYT, CYTARABINE
EXPAREL, BUPIVACAINE
PACK PHARMS LLC
* PACK PHARMACEUTICALS LLC
CROMOLYN SODIUM, CROMOLYN SODIUM
PADDOCK
* PADDOCK LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
PADDOCK LABS
* PADDOCK LABORATORIES INC
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
PADDOCK LLC
* PADDOCK LABORATORIES LLC
CALCIUM ACETATE, CALCIUM ACETATE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
REPAGLINIDE, REPAGLINIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
PAI
* PHARMACEUTICAL ASSOCIATES INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
PALADIN LABS
* PALADIN LABS USA INC
ANTIZOL, FOMEPIZOLE
PANACEA BIOTEC LTD
* PANACEA BIOTEC LTD
TACROLIMUS, TACROLIMUS
PAR FORM
* PAR FORMULATIONS PRIVATE LTD
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MAFENIDE ACETATE, MAFENIDE ACETATE
PAR PHARM
B - 84
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PAR PHARMACEUTICAL
NABUMETONE, NABUMETONE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
* PAR PHARMACEUTICAL INC
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
CABERGOLINE, CABERGOLINE
CALCITONIN-SALMON, CALCITONIN SALMON
CAPOTEN, CAPTOPRIL
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
DEXAMETHASONE, DEXAMETHASONE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
ESTAZOLAM, ESTAZOLAM
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
GLIPIZIDE, GLIPIZIDE
HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
MEGACE ES, MEGESTROL ACETATE
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NASCOBAL, CYANOCOBALAMIN
NATEGLINIDE, NATEGLINIDE
NIFEDIPINE, NIFEDIPINE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TORSEMIDE, TORSEMIDE
TRAVOPROST, TRAVOPROST
URSODIOL, URSODIOL
PAR PHARM INC
* PAR PHARMACEUTICAL INC
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
PARAGON BIOTECK
* PARAGON BIOTECK INC
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PARAPRO LLC
* PARAPRO LLC
NATROBA, SPINOSAD
PARKE DAVIS
* PARKE DAVIS DIV WARNER LAMBERT CO
DILANTIN, PHENYTOIN SODIUM
NARDIL, PHENELZINE SULFATE
B - 85
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PARKE DAVIS DIV WARNER LAMBERT CO
NEURONTIN, GABAPENTIN
ZARONTIN, ETHOSUXIMIDE
* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
ZARONTIN, ETHOSUXIMIDE
PEDIATRX
* PEDIATRX INC
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
PEDINOL
* PEDINOL PHARMACAL INC
GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE
PERNIX THERAP
* PERNIX THERAPEUTICS LLC
CEDAX, CEFTIBUTEN DIHYDRATE
PERNIX THERAPS LLC
* PERNIX THERAPEUTICS LLC
SILENOR, DOXEPIN HYDROCHLORIDE
PERRIGO
* PERRIGO CO
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CICLOPIROX, CICLOPIROX
CLINDETS, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
ERYTHROMYCIN, ERYTHROMYCIN
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
(OTC)
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
MOMETASONE FUROATE, MOMETASONE FUROATE
NICOTINE POLACRILEX, NICOTINE POLACRILEX
(OTC)
STIE-CORT, HYDROCORTISONE
PERRIGO CO TENNESSEE
* PERRIGO CO TENNESSEE INC
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN, BACITRACIN
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN
ERYTHROMYCIN, ERYTHROMYCIN
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
PERRIGO ISRAEL
* PERRIGO ISRAEL PHARMACEUTICALS
FLUOCINONIDE, FLUOCINONIDE
* PERRIGO ISRAEL PHARMACEUTICALS LTD
BUTOCONAZOLE NITRATE, BUTOCONAZOLE NITRATE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
MESALAMINE, MESALAMINE
MINOXIDIL, MINOXIDIL
(OTC)
NITROGLYCERIN, NITROGLYCERIN
TESTOSTERONE, TESTOSTERONE
PERRIGO NEW YORK
* PERRIGO NEW YORK INC
ACETAMINOPHEN, ACETAMINOPHEN
(OTC)
CENTANY, MUPIROCIN
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DESONIDE, DESONIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
B - 86
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PERRIGO NEW YORK INC
TERCONAZOLE, TERCONAZOLE
PERRIGO R AND D
* PERRIGO R AND D CO
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE
(OTC)
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
DESLORATADINE, DESLORATADINE
GUAIFENESIN, GUAIFENESIN
(OTC)
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE
(OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
LANSOPRAZOLE, LANSOPRAZOLE
(OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL
(OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
(OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
(OTC)
NAPROXEN, NAPROXEN
NICOTINE POLACRILEX, NICOTINE POLACRILEX
(OTC)
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
(OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
PERRIGO UK FINCO
* PERRIGO UK FINCO LTD PARTNERSHIP
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
PETNET
* PETNET SOLUTIONS INC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
PF PRISM
* PF PRISM CV
LYRICA, PREGABALIN
PF PRISM CV
* PF PRISM CV
RAPAMUNE, SIROLIMUS
TORISEL, TEMSIROLIMUS
TYGACIL, TIGECYCLINE
XALKORI, CRIZOTINIB
XELJANZ, TOFACITINIB CITRATE
ZMAX, AZITHROMYCIN
PFIZER
* PFIZER CENTRAL RESEARCH
DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER CHEMICALS DIV PFIZER INC
DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER INC
ACOVA, ARGATROBAN
ADVIL LIQUI-GELS, IBUPROFEN
(OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN
(OTC)
ALAVERT, LORATADINE
(OTC)
AXID AR, NIZATIDINE
(OTC)
CADUET, AMLODIPINE BESYLATE
CALAN SR, VERAPAMIL HYDROCHLORIDE
CARDURA XL, DOXAZOSIN MESYLATE
CHILDREN'S ADVIL, IBUPROFEN
(OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN
(OTC)
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
ELELYSO, TALIGLUCERASE ALFA
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
GEODON, ZIPRASIDONE HYDROCHLORIDE
B - 87
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PFIZER INC
GEODON, ZIPRASIDONE MESYLATE
GLUCOTROL XL, GLIPIZIDE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
INLYTA, AXITINIB
JUNIOR STRENGTH ADVIL, IBUPROFEN
(OTC)
LIPITOR, ATORVASTATIN CALCIUM
LORATADINE, LORATADINE
(OTC)
NAVANE, THIOTHIXENE
NORVASC, AMLODIPINE BESYLATE
PEDIATRIC ADVIL, IBUPROFEN
(OTC)
PROCARDIA, NIFEDIPINE
REVATIO, SILDENAFIL CITRATE
SONATA, ZALEPLON
TOVIAZ, FESOTERODINE FUMARATE
UNASYN, AMPICILLIN SODIUM
VFEND, VORICONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER LABORATORIES DIV PFIZER INC
CARDURA, DOXAZOSIN MESYLATE
PROCARDIA XL, NIFEDIPINE
UNASYN, AMPICILLIN SODIUM
VIBRAMYCIN, DOXYCYCLINE
* PFIZER PHARMACEUTICALS INC
ZOLOFT, SERTRALINE HYDROCHLORIDE
PFIZER CONS HLTHCARE
* PFIZER CONSUMER HEALTHCARE
ADVIL, IBUPROFEN SODIUM
(OTC)
PFIZER INC
* PFIZER INC
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
GEODON, ZIPRASIDONE HYDROCHLORIDE
NICOTROL, NICOTINE
PFIZER IRELAND
* PFIZER IRELAND PHARMACEUTICALS
RELPAX, ELETRIPTAN HYDROBROMIDE
VIAGRA, SILDENAFIL CITRATE
PFIZER PHARMS
* PFIZER PHARMACEUTICALS LTD
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
DILANTIN, PHENYTOIN
NEURONTIN, GABAPENTIN
NITROSTAT, NITROGLYCERIN
PHARM ASSOC
* PHARMACEUTICAL ASSOC INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LORAZEPAM, LORAZEPAM
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
PREDNISOLONE, PREDNISOLONE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
* PHARMACEUTICAL ASSOCIATES INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
B - 88
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
PHARMACEUTICS
* PHARMACEUTICS INTERNATIONAL INC
ZOLEDRONIC ACID, ZOLEDRONIC ACID
PHARMACHEMIE
* PHARMACHEMIE BV
CARBOPLATIN, CARBOPLATIN
PHARMACHEMIE BV
* PHARMACHEMIE BV
METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
PHARMACIA AND UPJOHN
* PHARMACIA AND UPJOHN
XANAX XR, ALPRAZOLAM
* PHARMACIA AND UPJOHN CO
AROMASIN, EXEMESTANE
AZULFIDINE EN-TABS, SULFASALAZINE
CAVERJECT IMPULSE, ALPROSTADIL
CAVERJECT, ALPROSTADIL
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLEOCIN, CLINDAMYCIN PHOSPHATE
COLESTID, COLESTIPOL HYDROCHLORIDE
CORTEF, HYDROCORTISONE
CORVERT, IBUTILIDE FUMARATE
CYKLOKAPRON, TRANEXAMIC ACID
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
MEDROL, METHYLPREDNISOLONE
NICOTROL, NICOTINE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMAVERT, PEGVISOMANT
XALATAN, LATANOPROST
ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZYVOX, LINEZOLID
* PHARMACIA AND UPJOHN SUB PFIZER INC
DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
PHARMACYCLICS INC
* PHARMACYCLICS INC
IMBRUVICA, IBRUTINIB
PHARMAFORCE
* PHARMAFORCE INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
PHARMALUCENCE
* PHARMALUCENCE INC
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
PHARMAX
* PHARMAX GROUP INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
PHARMAXIS LTD
* PHARMAXIS LTD
ARIDOL KIT, MANNITOL
PHARMS
B - 89
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PHARMACEUTICALS INTERNATIONAL
ZOLEDRONIC ACID, ZOLEDRONIC ACID
PHOTOCURE ASA
* PHOTOCURE ASA
CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE
PIERRE FABRE
* PIERRE FABRE MEDICAMENT
NAVELBINE, VINORELBINE TARTRATE
PIERREL
* PIERREL S.P.A.
ORABLOC, ARTICAINE HYDROCHLORIDE
PINNACLE BIOLGS
* PINNACLE BIOLOGICS INC
PHOTOFRIN, PORFIMER SODIUM
PLD ACQUISITIONS
* PLD ACQUISITIONS LLC
IBUPROFEN, IBUPROFEN
(OTC)
PLIVA
* PLIVA INC
AZITHROMYCIN, AZITHROMYCIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
WARFARIN SODIUM, WARFARIN SODIUM
PLIVA HRVATSKA DOO
* PLIVA HRVATSKA DOO
ADAPALENE, ADAPALENE
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
PLIVA LACHEMA
* PLIVA LACHEMA AS
CARBOPLATIN, CARBOPLATIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PLIVA PHARM IND
* PLIVA PHARMACEUTICAL INDUSTRY INC
TORSEMIDE, TORSEMIDE
PLX PHARMA
* PLX PHARMA INC
ASPIRIN, ASPIRIN
(OTC)
POHL BOSKAMP
* POHL BOSKAMP
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
PRECISION DERMAT
* PRECISION DERMATOLOGY INC
CLINDAGEL, CLINDAMYCIN PHOSPHATE
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE
PODOFILOX, PODOFILOX
TRETINOIN, TRETINOIN
PRECISION DOSE
* PRECISION DOSE INC
RISPERIDONE, RISPERIDONE
PRINSTON INC
* PRINSTON PHARMACEUTICAL INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
IRBESARTAN, IRBESARTAN
B - 90
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PRINSTON PHARMACEUTICAL INC
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METHOCARBAMOL, METHOCARBAMOL
NEVIRAPINE, NEVIRAPINE
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
PROCTER AND GAMBLE
* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
DIDRONEL, ETIDRONATE DISODIUM
PROF DSPLS
* PROFESSIONAL DISPOSABLES INC
PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE
(OTC)
PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE
(OTC)
PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE
(OTC)
PROMETHEUS LABS
* PROMETHEUS LABORATORIES INC
HELIDAC, BISMUTH SUBSALICYLATE
IMURAN, AZATHIOPRINE
LOTRONEX, ALOSETRON HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
RIDAURA, AURANOFIN
ZYLOPRIM, ALLOPURINOL
PROMIUS PHARMA
* PROMIUS PHARMA LLC
SECTRAL, ACEBUTOLOL HYDROCHLORIDE
TENEX, GUANFACINE HYDROCHLORIDE
PROMIUS PHARMA LLC
* PROMIUS PHARMA LLC
CLODERM, CLOCORTOLONE PIVALATE
PROSAM LABS
* PROSAM LABS LLC
BACLOFEN, BACLOFEN
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
RIMACTANE, RIFAMPIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
PROSTRAKAN INC
* PROSTRAKAN INC
FARESTON, TOREMIFENE CITRATE
SANCUSO, GRANISETRON
PROVENSIS
* PROVENSIS LTD
VARITHENA, POLIDOCANOL
PROVIDENT PHARM
* PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PULSION MEDCL
* PULSION MEDICAL SYSTEMS AG
INDOCYANINE GREEN, INDOCYANINE GREEN
PURACAP PHARM
* PURACAP PHARMACEUTICAL LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
MELOXICAM, MELOXICAM
PURDUE GMP
* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY
B - 91
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
P
**
* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY
SEROMYCIN, CYCLOSERINE
PURDUE PHARM PRODS
* PURDUE PHARMACEUTICAL PRODUCTS LP
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
PURDUE PHARMA
* PURDUE PHARMA PRODUCTS LP
INTERMEZZO, ZOLPIDEM TARTRATE
PURDUE PHARMA LP
* PURDUE PHARMA LP
BUTRANS, BUPRENORPHINE
MS CONTIN, MORPHINE SULFATE
OXYCONTIN, OXYCODONE HYDROCHLORIDE
**
Q
**
**
R
**
QOL MEDCL
* QOL MEDICAL LLC
ETHAMOLIN, ETHANOLAMINE OLEATE
SUCRAID, SACROSIDASE
QUESTCOR PHARMS
* QUESTCOR PHARMACEUTICALS INC
H.P. ACTHAR GEL, CORTICOTROPIN
RANBAXY
* RANBAXY INC
ABSORICA, ISOTRETINOIN
GLYCOPYRROLATE, GLYCOPYRROLATE
* RANBAXY LABORATORIES INC
EURAX, CROTAMITON
EXELDERM, SULCONAZOLE NITRATE
FAMOTIDINE, FAMOTIDINE
(OTC)
HALOG, HALCINONIDE
KENALOG, TRIAMCINOLONE ACETONIDE
LAC-HYDRIN, AMMONIUM LACTATE
RISPERIDONE, RISPERIDONE
ULTRAVATE, HALOBETASOL PROPIONATE
* RANBAXY LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CLARITHROMYCIN, CLARITHROMYCIN
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
FENOFIBRATE, FENOFIBRATE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE
(OTC)
LORATADINE REDIDOSE, LORATADINE
(OTC)
B - 92
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
R
**
* RANBAXY LABORATORIES LTD
LORATADINE, LORATADINE
(OTC)
LORAZEPAM, LORAZEPAM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
(OTC)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SOTRET, ISOTRETINOIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOPIRAMATE, TOPIRAMATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* RANBAXY PHARMACEUTICALS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE
(OTC)
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE
SOTRET, ISOTRETINOIN
RANBAXY LABS LTD
* RANBAXY LABORATORIES LIMITED
NAPROXEN SODIUM, NAPROXEN SODIUM
(OTC)
* RANBAXY LABORATORIES LTD
ACETAMINOPHEN, ACETAMINOPHEN
(OTC)
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
FELODIPINE, FELODIPINE
MORPHINE SULFATE, MORPHINE SULFATE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
RAPTOR PHARMS
* RAPTOR PHARMACEUTICALS CORP
PROCYSBI, CYSTEAMINE BITARTRATE
RARE DIS THERAP
* RARE DISEASE THERAPEUTICS INC
CYSTADANE, BETAINE HYDROCHLORIDE
RECIP
* RECIP AB
THYROSAFE, POTASSIUM IODIDE
(OTC)
RECKITT BENCKISER
* RECKITT BENCKISER LLC
DELSYM, DEXTROMETHORPHAN POLISTIREX
(OTC)
MUCINEX D, GUAIFENESIN
(OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE
(OTC)
MUCINEX, GUAIFENESIN
(OTC)
* RECKITT BENCKISER PHARMACEUTICALS INC
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
RECORDATI RARE
* RECORDATI RARE DISEASES INC
CHEMET, SUCCIMER
COSMEGEN, DACTINOMYCIN
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
INDOCIN, INDOMETHACIN SODIUM
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
NEOPROFEN, IBUPROFEN LYSINE
B - 93
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
R
**
* RECORDATI RARE DISEASES INC
PEGANONE, ETHOTOIN
TRANXENE, CLORAZEPATE DIPOTASSIUM
REMPEX PHARMS INC
* REMPEX PHARMACEUTICALS INC
MINOCIN, MINOCYCLINE HYDROCHLORIDE
RENAISSANCE PHARMA
* RENAISSANCE PHARMA US HOLDINGS INC
ELIMITE, PERMETHRIN
RHODES PHARMS
* RHODES PHARMACEUTICALS LP
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
UNIPHYL, THEOPHYLLINE
RICONPHARMA LLC
* RICONPHARMA LLC
GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
ROCHE PALO
* ROCHE PALO ALTO LLC
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CYTOVENE, GANCICLOVIR SODIUM
ROCKWELL MEDCL
* ROCKWELL MEDICAL TECHNOLOGIES INC
CALCITRIOL, CALCITRIOL
ROMARK
* ROMARK LABORATORIES
ALINIA, NITAZOXANIDE
ROSEDALE THERAPEUTIC
* ROSEDALE THERAPEUTICS
ERGOMAR, ERGOTAMINE TARTRATE
ROUSES POINT PHARMS
* ROUSES POINT PHARMACEUTICALS LLC
LEVETIRACETAM, LEVETIRACETAM
ROXANE
* ROXANE LABORATORIES INC
ACARBOSE, ACARBOSE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BICALUTAMIDE, BICALUTAMIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CODEINE SULFATE, CODEINE SULFATE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXAMETHASONE, DEXAMETHASONE
DIGOXIN, DIGOXIN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
EXEMESTANE, EXEMESTANE
FAMCICLOVIR, FAMCICLOVIR
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
B - 94
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
R
**
* ROXANE LABORATORIES INC
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FUROSEMIDE, FUROSEMIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LITHIUM CARBONATE, LITHIUM CARBONATE
LORAZEPAM INTENSOL, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PREDNISONE, PREDNISONE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROXICET, ACETAMINOPHEN
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TINIDAZOLE, TINIDAZOLE
TORSEMIDE, TORSEMIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
**
S
**
SAGE PRODS
* SAGE PRODUCTS INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
(OTC)
SAGENT AGILA
* SAGENT AGILA LLC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SAGENT PHARMS
* SAGENT PHARMACEUTICALS INC
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
B - 95
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SAGENT PHARMACEUTICALS INC
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CARBOPLATIN, CARBOPLATIN
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
FLUMAZENIL, FLUMAZENIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
MESNA, MESNA
NAFCILLIN SODIUM, NAFCILLIN SODIUM
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXACILLIN SODIUM, OXACILLIN SODIUM
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
SAGENT STRIDES
* SAGENT STRIDES LLC
AZITHROMYCIN, AZITHROMYCIN
BACITRACIN, BACITRACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SALIX PHARMS
* SALIX PHARMACEUTICALS INC
ANUSOL HC, HYDROCORTISONE
APRISO, MESALAMINE
COLAZAL, BALSALAZIDE DISODIUM
DIURIL, CHLOROTHIAZIDE
FULYZAQ, CROFELEMER
GIAZO, BALSALAZIDE DISODIUM
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
MOVIPREP, ASCORBIC ACID
OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
PEPCID, FAMOTIDINE
RELISTOR, METHYLNALTREXONE BROMIDE
XIFAXAN, RIFAXIMIN
SALIX PHARMS INC
* SALIX PHARMACEUTICALS INC
FENOGLIDE, FENOFIBRATE
GLUMETZA, METFORMIN HYDROCHLORIDE
ZEGERID, OMEPRAZOLE
SAMSON MEDCL
* SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
SANDOZ
* SANDOZ
DOCETAXEL, DOCETAXEL
* SANDOZ CANADA INC
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
B - 96
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 97
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SANDOZ CANADA INC
COSYNTROPIN, COSYNTROPIN
DIGOXIN, DIGOXIN
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
ESTRADIOL VALERATE, ESTRADIOL VALERATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID
ISONIAZID, ISONIAZID
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
* SANDOZ INC
ALTAVERA, ETHINYL ESTRADIOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ANASTROZOLE, ANASTROZOLE
APREPITANT, APREPITANT
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
AZITHROMYCIN, AZITHROMYCIN
BICALUTAMIDE, BICALUTAMIDE
BUDESONIDE, BUDESONIDE
BUMETANIDE, BUMETANIDE
CAFERGOT, CAFFEINE
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CILOSTAZOL, CILOSTAZOL
CLARITHROMYCIN, CLARITHROMYCIN
COSYNTROPIN, COSYNTROPIN
DESLORATADINE, DESLORATADINE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SANDOZ INC
EPLERENONE, EPLERENONE
ESTARYLLA, ETHINYL ESTRADIOL
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HALOPERIDOL, HALOPERIDOL
HEPARIN SODIUM, HEPARIN SODIUM
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
INTROVALE, ETHINYL ESTRADIOL
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMIDE, LEFLUNOMIDE
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LORAZEPAM, LORAZEPAM
LORYNA, DROSPIRENONE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OMEPRAZOLE, OMEPRAZOLE
OMNITROPE, SOMATROPIN RECOMBINANT
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXACILLIN SODIUM, OXACILLIN SODIUM
OXALIPLATIN, OXALIPLATIN
PENICILLIN G SODIUM, PENICILLIN G SODIUM
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERPHENAZINE, PERPHENAZINE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL
REPAGLINIDE, REPAGLINIDE
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SYEDA, DROSPIRENONE
TACROLIMUS, TACROLIMUS
B - 98
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SANDOZ INC
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRI-ESTARYLLA, ETHINYL ESTRADIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
SANDOZ CANADA INC
* SANDOZ CANADA INC
PARICALCITOL, PARICALCITOL
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
SANDOZ INC
* SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
OLANZAPINE, OLANZAPINE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
SANOCHEMIA CORP USA
* SANOCHEMIA CORP USA
SCANLUX-300, IOPAMIDOL
SCANLUX-370, IOPAMIDOL
SANOFI AVENTIS US
* SANOFI AVENTIS US INC
JEVTANA KIT, CABAZITAXEL
* SANOFI AVENTIS US LLC
ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE
(OTC)
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE
(OTC)
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
ANZEMET, DOLASETRON MESYLATE
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APIDRA, INSULIN GLULISINE RECOMBINANT
AUBAGIO, TERIFLUNOMIDE
AUVI-Q, EPINEPHRINE
AVALIDE, HYDROCHLOROTHIAZIDE
AVAPRO, IRBESARTAN
CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
CLAFORAN, CEFOTAXIME SODIUM
DDAVP, DESMOPRESSIN ACETATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DIABETA, GLYBURIDE
ELOXATIN, OXALIPLATIN
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
MULTAQ, DRONEDARONE HYDROCHLORIDE
NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE
(OTC)
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
PLAVIX, CLOPIDOGREL BISULFATE
B - 99
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SANOFI AVENTIS US LLC
RIFAMATE, ISONIAZID
TAXOTERE, DOCETAXEL
SANOFI PASTEUR INC
* SANOFI PASTEUR INC
SKLICE, IVERMECTIN
SANTARUS
* SANTARUS INC
UCERIS, BUDESONIDE
SANTEN
* SANTEN INC
IQUIX, LEVOFLOXACIN
QUIXIN, LEVOFLOXACIN
SANTOS BIOTECH
* SANTOS BIOTECH INDUSTRIES INC
ANASTROZOLE, ANASTROZOLE
SAVIENT PHARMS
* SAVIENT PHARMACEUTICALS INC
OXANDRIN, OXANDROLONE
SB PHARMCO
* SB PHARMCO PUERTO RICO INC
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE
COREG CR, CARVEDILOL PHOSPHATE
SCHERING
* SCHERING CORP
ASMANEX TWISTHALER, MOMETASONE FUROATE
INTEGRILIN, EPTIFIBATIDE
NOXAFIL, POSACONAZOLE
REBETOL, RIBAVIRIN
SCHERING CORP
* SCHERING CORP
LOTRISONE, BETAMETHASONE DIPROPIONATE
SCHERING PLOUGH
* SCHERING PLOUGH HEALTHCARE PRODUCTS INC
CHILDREN'S CLARITIN, LORATADINE
(OTC)
CLARITIN HIVES RELIEF REDITAB, LORATADINE
(OTC)
CLARITIN HIVES RELIEF, LORATADINE
(OTC)
CLARITIN REDITABS, LORATADINE
(OTC)
CLARITIN, LORATADINE
(OTC)
CLARITIN-D 24 HOUR, LORATADINE
(OTC)
CLARITIN-D, LORATADINE
(OTC)
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE
(OTC)
MIRALAX, POLYETHYLENE GLYCOL 3350
(OTC)
NASONEX, MOMETASONE FUROATE MONOHYDRATE
SHADE UVAGUARD, AVOBENZONE
(OTC)
SCIECURE PHARMA INC
* SCIECURE PHARMA INC
DORAL, QUAZEPAM
SCIEGEN PHARMS INC
* SCIEGEN PHARMACEUTICALS INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NEVIRAPINE, NEVIRAPINE
SCIOS LLC
* SCIOS LLC
NATRECOR, NESIRITIDE RECOMBINANT
SEBELA IRELAND LTD
* SEBELA IRELAND LTD
MICORT-HC, HYDROCORTISONE ACETATE
PRAMOSONE, HYDROCORTISONE ACETATE
SECAN PHARMS
* SECAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
B - 100
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
SEPTODONT
* SEPTODONT INC
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
OCTOCAINE, EPINEPHRINE
SEPTODONT HOLDING
* SEPTODONT HOLDING SAS
ORAVERSE, PHENTOLAMINE MESYLATE
SEPTODONT INC
* SEPTODONT INC
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE
PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE
SETON PHARM
* SETON PHARMACEUTICAL LLC
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
SHASUN CHEMS
* SHASUN CHEMICALS AND DRUGS LTD
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
SHASUN USA
* SHASUN USA INC
IBUPROFEN, IBUPROFEN
SHIONOGI INC
* SHIONOGI INC
DORIBAX, DORIPENEM
KEFLEX, CEPHALEXIN
MOXATAG, AMOXICILLIN
OSPHENA, OSPEMIFENE
SHIRE
* SHIRE DEVELOPMENT INC
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
CARBATROL, CARBAMAZEPINE
INTUNIV, GUANFACINE HYDROCHLORIDE
LIALDA, MESALAMINE
SHIRE DEVELOPMENT
* SHIRE DEVELOPMENT INC
VYVANSE, LISDEXAMFETAMINE DIMESYLATE
SHIRE HUMAN GENETIC
* SHIRE HUMAN GENETIC THERAPIES INC
VPRIV, VELAGLUCERASE ALFA
SHIRE LLC
* SHIRE DEVELOPMENT LLC
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
FOSRENOL, LANTHANUM CARBONATE
SALURON, HYDROFLUMETHIAZIDE
SHIRE ORPHAN THERAP
* SHIRE ORPHAN THERAPIES INC
FIRAZYR, ICATIBANT ACETATE
SIGMA TAU
* SIGMA TAU PHARMACEUTICALS INC
ABELCET, AMPHOTERICIN B
ADAGEN, PEGADEMASE BOVINE
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE
CYSTARAN, CYSTEAMINE HYDROCHLORIDE
SIGMAPHARM LABS LLC
* SIGMAPHARM LABORATORIES LLC
ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
DISULFIRAM, DISULFIRAM
ERGOCALCIFEROL, ERGOCALCIFEROL
B - 101
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SIGMAPHARM LABORATORIES LLC
FLUCYTOSINE, FLUCYTOSINE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
SILARX
* SILARX PHARMACEUTICALS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE
(OTC)
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
SILARX PHARMS INC
* SILARX PHARMACEUTICALS INC
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
SILVERGATE PHARMS
* SILVERGATE PHARMACEUTICALS INC
EPANED KIT, ENALAPRIL MALEATE
SKINMEDICA
* SKINMEDICA INC
VANIQA, EFLORNITHINE HYDROCHLORIDE
SKYEPHARMA AG
* SKYEPHARMA AG
TRIGLIDE, FENOFIBRATE
SMITHKLINE BEECHAM
* SMITHKLINE BEECHAM
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ARRANON, NELARABINE
COREG, CARVEDILOL
TREXIMET, NAPROXEN SODIUM
TYKERB, LAPATINIB DITOSYLATE
SOFGEN PHARMS
* SOFGEN PHARMACEUTICALS LLC
PROGESTERONE, PROGESTERONE
SOMERSET
* SOMERSET PHARMACEUTICALS INC
EMSAM, SELEGILINE
SPEAR PHARMS
* SPEAR PHARMACEUTICALS INC
FLUOROURACIL, FLUOROURACIL
SPEAR PHARMS INC
* SPEAR PHARMACEUTICALS INC
TRETINOIN, TRETINOIN
SPECTRUM PHARMS
* SPECTRUM PHARMACEUTICALS INC
FUSILEV, LEVOLEUCOVORIN CALCIUM
STAND HOMEOPATH
* STANDARD HOMEOPATHIC CO
IVY BLOCK, BENTOQUATAM
(OTC)
STASON PHARMS
* STASON PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
STERI PHARMA
B - 102
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* STERI PHARMA LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
STI PHARMA LLC
* STI PHARMA LLC
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
DEXAMETHASONE, DEXAMETHASONE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE
TRIACIN-C, CODEINE PHOSPHATE
STIEFEL
* STIEFEL LABORATORIES INC
DUAC, BENZOYL PEROXIDE
STIEFEL GSK
* STIEFEL A GSK CO
VELTIN, CLINDAMYCIN PHOSPHATE
STIEFEL LABS INC
* STIEFEL LABORATORIES INC
EXTINA, KETOCONAZOLE
FABIOR, TAZAROTENE
OLUX, CLOBETASOL PROPIONATE
SORIATANE, ACITRETIN
SORILUX, CALCIPOTRIENE
VUSION, MICONAZOLE NITRATE
STRIDES
* STRIDES INC
NEVIRAPINE, NEVIRAPINE
STRIDES ARCOLAB
* STRIDES ARCOLAB LIMITED
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
STRIDES ARCOLAB LTD
* STRIDES ARCOLAB LTD
ACARBOSE, ACARBOSE
ADENOSINE, ADENOSINE
CEFTRIAXONE, CEFTRIAXONE SODIUM
ERGOCALCIFEROL, ERGOCALCIFEROL
ETOMIDATE, ETOMIDATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
(OTC)
MELOXICAM, MELOXICAM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
SUCAMPO PHARMS
* SUCAMPO PHARMACEUTICALS INC
AMITIZA, LUBIPROSTONE
RESCULA, UNOPROSTONE ISOPROPYL
SUN PHARM INDS
* SUN PHARMACEUTICAL INDUSTRIES LTD
CARBIDOPA AND LEVODOPA, CARBIDOPA
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
DESLORATADINE, DESLORATADINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OLANZAPINE, OLANZAPINE
B - 103
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 104
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SUN PHARMACEUTICAL INDUSTRIES LTD
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE
TORSEMIDE, TORSEMIDE
SUN PHARM INDS (IN)
* SUN PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN, CEPHALEXIN
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
ZONISAMIDE, ZONISAMIDE
SUN PHARM INDS INC
* SUN PHARMACEUTICAL INDUSTRIES INC
ERGOCALCIFEROL, ERGOCALCIFEROL
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
LITHIUM CARBONATE, LITHIUM CARBONATE
NIMODIPINE, NIMODIPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
SUN PHARM INDS LTD
* SUN PHARMACEUTICAL INDUSTRIES LTD
AZITHROMYCIN, AZITHROMYCIN
CARISOPRODOL, CARISOPRODOL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
GABAPENTIN, GABAPENTIN
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
NARATRIPTAN, NARATRIPTAN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RILUZOLE, RILUZOLE
RISPERIDONE, RISPERIDONE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
* SUN PHARMACEUTICAL INDUSTRIES LTD.
ANASTROZOLE, ANASTROZOLE
SUN PHARMA GLOBAL
* SUN PHARMA GLOBAL FZE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DESMOPRESSIN ACETATE , DESMOPRESSIN ACETATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOCEFREZ, DOCETAXEL
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENTACAPONE, ENTACAPONE
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ESZOPICLONE, ESZOPICLONE
FINASTERIDE, FINASTERIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SUN PHARMA GLOBAL FZE
LANSOPRAZOLE, LANSOPRAZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
* SUN PHARMA GLOBAL INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMIFOSTINE, AMIFOSTINE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE
SUNEVA MEDCL
* SUNEVA MEDICAL INC
TRETINOIN, TRETINOIN
SUNOVION
* SUNOVION PHARMACEUTICALS INC
BROVANA, ARFORMOTEROL TARTRATE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
SUNOVION PHARMS INC
* SUNOVION PHARMACEUTICALS INC
APTIOM, ESLICARBAZEPINE ACETATE
LATUDA, LURASIDONE HYDROCHLORIDE
LUNESTA, ESZOPICLONE
SUNSHINE LAKE
* SUNSHINE LAKE PHARMA CO LTD
ZIDOVUDINE, ZIDOVUDINE
SUNSTAR AMERICAS
* SUNSTAR AMERICAS INC
PAROEX, CHLORHEXIDINE GLUCONATE
SUPERNUS PHARMS
* SUPERNUS PHARMACEUTICALS INC
OXTELLAR XR, OXCARBAZEPINE
TROKENDI XR, TOPIRAMATE
SUVEN LIFE
* SUVEN LIFE SCIENCES LTD
MALATHION, MALATHION
SVADS HOLDINGS SA
* SVADS HOLDINGS SA
IBUPROFEN, IBUPROFEN
(OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
SVC PHARMA
* SVC PHARMA LP
DRONABINOL, DRONABINOL
SWEDISH ORPHAN
* SWEDISH ORPHAN BIOVITRUM AB PUBL
B - 105
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
S
**
* SWEDISH ORPHAN BIOVITRUM AB PUBL
ORFADIN, NITISINONE
SYNTHON PHARMS
* SYNTHON PHARMACEUTICALS INC
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
** T
**
MEDICINES CO
* THE MEDICINES CO
ANGIOMAX, BIVALIRUDIN
CLEVIPREX, CLEVIDIPINE
RITEDOSE CORP
* THE RITEDOSE CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
TAKEDA GMBH
* TAKEDA GMBH
ALVESCO, CICLESONIDE
OMNARIS, CICLESONIDE
ZETONNA, CICLESONIDE
TAKEDA PHARMS
* TAKEDA PHARMACEUTICALS NORTH AMERICA INC
DEXILANT, DEXLANSOPRAZOLE
TAKEDA PHARMS USA
* TAKEDA PHARMACEUTICALS USA INC
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
ACTOS, PIOGLITAZONE HYDROCHLORIDE
BRINTELLIX, VORTIOXETINE HYDROBROMIDE
COLCRYS, COLCHICINE
DUETACT, GLIMEPIRIDE
KAZANO, ALOGLIPTIN BENZOATE
NESINA, ALOGLIPTIN BENZOATE
OSENI, ALOGLIPTIN BENZOATE
PREVACID, LANSOPRAZOLE
PREVPAC, AMOXICILLIN
ROZEREM, RAMELTEON
ULORIC, FEBUXOSTAT
TALON THERAP
* TALON THERAPEUTICS INC
MARQIBO KIT, VINCRISTINE SULFATE
TAMARANG
* TAMARANG SA
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
TARO
* TARO PHARMACEUTICAL INDUSTRIES LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FLUCONAZOLE, FLUCONAZOLE
FLUOROURACIL, FLUOROURACIL
GABAPENTIN, GABAPENTIN
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
B - 106
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* TARO PHARMACEUTICAL INDUSTRIES LTD
IMIQUIMOD, IMIQUIMOD
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE
(OTC)
MELOXICAM, MELOXICAM
METRONIDAZOLE, METRONIDAZOLE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
PHENYTOIN, PHENYTOIN
* TARO PHARMACEUTICALS INC
CLOTRIMAZOLE, CLOTRIMAZOLE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
FLUOCINONIDE, FLUOCINONIDE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
TOPICORT, DESOXIMETASONE
* TARO PHARMACEUTICALS USA INC
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM LACTATE, AMMONIUM LACTATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CICLOPIROX, CICLOPIROX
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FLO-PRED, PREDNISOLONE ACETATE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOROURACIL, FLUOROURACIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
KETOZOLE, KETOCONAZOLE
LORATADINE, LORATADINE
(OTC)
MICONAZOLE 3, MICONAZOLE NITRATE
(OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
(OTC)
TERCONAZOLE, TERCONAZOLE
TERIL, CARBAMAZEPINE
TOPICORT, DESOXIMETASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIVAGIZOLE 3, CLOTRIMAZOLE
(OTC)
U-CORT, HYDROCORTISONE ACETATE
* TARO PHARMACEUTICALS, INC.
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
TOPICORT, DESOXIMETASONE
TARO PHARM INDS
* TARO PHARMACEUTICAL INDUSTRIES LTD
AMCINONIDE, AMCINONIDE
CARBAMAZEPINE, CARBAMAZEPINE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
B - 107
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* TARO PHARMACEUTICAL INDUSTRIES LTD
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
TARO PHARMS IRELAND
* TARO PHARMACEUTICALS IRELAND LTD
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
TARO PHARMS NORTH
* TARO PHARMACEUTICALS NORTH AMERICA INC
ACETAMINOPHEN, ACETAMINOPHEN
(OTC)
INFANTS' FEVERALL, ACETAMINOPHEN
(OTC)
OVIDE, MALATHION
TOPICORT, DESOXIMETASONE
TEDOR PHARM
* TEDOR PHARMA INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
TEDOR PHARMA INC
* TEDOR PHARMA INC
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
TEIKOKU PHARMA USA
* TEIKOKU PHARMA USA INC
LIDODERM, LIDOCAINE
TEVA
* TEVA NEUROSCIENCE INC
AZILECT, RASAGILINE MESYLATE
* TEVA PHARMACEUTICALS USA INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE
ATENOLOL, ATENOLOL
AZITHROMYCIN, AZITHROMYCIN
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CALCITRIOL, CALCITRIOL
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
CILOSTAZOL, CILOSTAZOL
CLARITHROMYCIN, CLARITHROMYCIN
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DIFLUNISAL, DIFLUNISAL
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ESTAZOLAM, ESTAZOLAM
ETODOLAC, ETODOLAC
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
(OTC)
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
B - 108
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* TEVA PHARMACEUTICALS USA INC
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
GLYBURIDE, GLYBURIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LORATADINE, LORATADINE
(OTC)
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
MESALAMINE, MESALAMINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MUPIROCIN, MUPIROCIN
NABUMETONE, NABUMETONE
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NIZATIDINE, NIZATIDINE
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXAPROZIN, OXAPROZIN
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN-VK, PENICILLIN V POTASSIUM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRELONE, PREDNISOLONE
PURINETHOL, MERCAPTOPURINE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIMETHOPRIM, TRIMETHOPRIM
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
B - 109
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
TEVA BRANDED PHARM
* TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
LOSEASONIQUE, ETHINYL ESTRADIOL
MIRCETTE, DESOGESTREL
NORDETTE-28, ETHINYL ESTRADIOL
PLAN B ONE-STEP, LEVONORGESTREL
(OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL
(OTC)
PROAIR HFA, ALBUTEROL SULFATE
PROGLYCEM, DIAZOXIDE
QNASL, BECLOMETHASONE DIPROPIONATE
QUARTETTE, ETHINYL ESTRADIOL
QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE
SEASONALE, ETHINYL ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL
TEVA PHARMS
* TEVA PHARMACEUTICALS USA
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE
ANASTROZOLE, ANASTROZOLE
AZITHROMYCIN, AZITHROMYCIN
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BUDESONIDE, BUDESONIDE
CARBAMAZEPINE, CARBAMAZEPINE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPROZIL, CEFPROZIL
CEFUROXIME SODIUM, CEFUROXIME SODIUM
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CROMOLYN SODIUM, CROMOLYN SODIUM
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FAMCICLOVIR, FAMCICLOVIR
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUVASTATIN SODIUM, FLUVASTATIN SODIUM
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMIDE, LEFLUNOMIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LINEZOLID, LINEZOLID
B - 110
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* TEVA PHARMACEUTICALS USA
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MEBENDAZOLE, MEBENDAZOLE
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXICAM, MELOXICAM
METHAZOLAMIDE, METHAZOLAMIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PREGABALIN, PREGABALIN
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROGESTERONE, PROGESTERONE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINIDINE SULFATE, QUINIDINE SULFATE
QUININE SULFATE, QUININE SULFATE
RAMIPRIL, RAMIPRIL
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TESTOSTERONE, TESTOSTERONE
THEOPHYLLINE, THEOPHYLLINE
TRANDOLAPRIL, TRANDOLAPRIL
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
VANDAZOLE, METRONIDAZOLE
VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
ZALEPLON, ZALEPLON
TEVA PHARMS USA
* TEVA PHARMACEUTICALS USA
ACITRETIN, ACITRETIN
ADENOSINE, ADENOSINE
ALPROSTADIL, ALPROSTADIL
AMIKACIN SULFATE, AMIKACIN SULFATE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN
CEFTRIAXONE, CEFTRIAXONE SODIUM
CLARAVIS, ISOTRETINOIN
COPAXONE, GLATIRAMER ACETATE
CYTOSAR-U, CYTARABINE
DACARBAZINE, DACARBAZINE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESVENLAFAXINE FUMARATE, DESVENLAFAXINE FUMARATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
B - 111
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* TEVA PHARMACEUTICALS USA
ETOPOSIDE, ETOPOSIDE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
IFOSFAMIDE/MESNA KIT, IFOSFAMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MESNA, MESNA
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PARICALCITOL, PARICALCITOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPOFOL, PROPOFOL
RAMELTEON, RAMELTEON
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOBRAMYCIN, TOBRAMYCIN
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ZANOSAR, STREPTOZOCIN
* TEVA PHARMACEUTICALS USA INC
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
CAPECITABINE, CAPECITABINE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
IMIQUIMOD, IMIQUIMOD
METRONIDAZOLE, METRONIDAZOLE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TEVA PHARMS USA INC
* TEVA PHARMACEUTICALS USA INC
ADASUVE, LOXAPINE
TEVA WOMENS
* TEVA WOMENS HEALTH INC
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
PARAGARD T 380A, COPPER
PREFEST, ESTRADIOL
REVIA, NALTREXONE HYDROCHLORIDE
ZEBETA, BISOPROLOL FUMARATE
ZIAC, BISOPROLOL FUMARATE
THE PHARMA NETWORK
* THE PHARMA NETWORK LLC
BENZONATATE, BENZONATATE
THE PHARMANETWORK
B - 112
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
T
**
* THE PHARMANETWORK LLC
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
THEPHARMANETWORK LLC
* THEPHARMANETWORK LLC
THERMAZENE, SILVER SULFADIAZINE
THERAVANCE INC
* THERAVANCE INC
VIBATIV, TELAVANCIN HYDROCHLORIDE
THREE RIVERS PHARMS
* THREE RIVERS PHARMACEUTICALS LLC
ANASTROZOLE, ANASTROZOLE
RIBASPHERE, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TOLMAR
* TOLMAR INC
ADAPALENE, ADAPALENE
ATRIDOX, DOXYCYCLINE HYCLATE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
DICLOFENAC SODIUM , DICLOFENAC SODIUM
IMIQUIMOD, IMIQUIMOD
LEVETIRACETAM, LEVETIRACETAM
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TOLMAR THERAP
* TOLMAR THERAPEUTICS INC
ELIGARD, LEUPROLIDE ACETATE
TORPHARM
* TORPHARM INC
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
TORRENT PHARM
* TORRENT PHARMA INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TORRENT PHARMS
* TORRENT PHARMACEUTICALS LIMITED
LEVOFLOXACIN, LEVOFLOXACIN
* TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARBAMAZEPINE, CARBAMAZEPINE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* TORRENT PHARMACEUTICALS LTD.
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
TORRENT PHARMS LLC
* TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
OLANZAPINE, OLANZAPINE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
B - 113
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
B - 114
PRODUCT NAME SORTED BY APPLICANT
**
T
**
TORRENT PHARMS LTD
* TORRENT PHARMACEUTICALS LTD
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELODIPINE, FELODIPINE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
OLANZAPINE, OLANZAPINE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIS PHARMA INC
* TRIS PHARMA INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE
(OTC)
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX
(OTC)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
IBUPROFEN, IBUPROFEN
(OTC)
KARBINAL ER, CARBINOXAMINE MALEATE
LEVETIRACETAM, LEVETIRACETAM
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
THEOPHYLLINE, THEOPHYLLINE
TWI PHARMS INC
* TWI PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
**
U
**
UCB INC
* UCB INC
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
LORTAB, ACETAMINOPHEN
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
NEUPRO, ROTIGOTINE
NIRAVAM, ALPRAZOLAM
PARCOPA, CARBIDOPA
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
UNIRETIC, HYDROCHLOROTHIAZIDE
UNIVASC, MOEXIPRIL HYDROCHLORIDE
VIMPAT, LACOSAMIDE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE
UCLA BIOMEDICAL
* UCLA BIOMEDICAL CYCLOTRON
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
UCYCLYD
* UCYCLYD PHARMA INC
AMMONUL, SODIUM BENZOATE
UNICHEM
* UNICHEM LABORATORIES LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
U
**
* UNICHEM LABORATORIES LTD
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MELOXICAM, MELOXICAM
ZALEPLON, ZALEPLON
UNICHEM LABS LTD
* UNICHEM LABORATORIES LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* UNICHEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
LAMOTRIGINE, LAMOTRIGINE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
UNICHEM PHARMS (USA)
* UNICHEM PHARMACEUTICALS (USA) INC
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
UNIQUE PHARM LABS
* UNIQUE PHARMACEUTICAL LABORATORIES
ATENOLOL, ATENOLOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE
(OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FLUCONAZOLE, FLUCONAZOLE
TINIDAZOLE, TINIDAZOLE
UNITED BIOMEDCL
* UNITED BIOMEDICAL INC
TERBUTALINE SULFATE, TERBUTALINE SULFATE
UNITED GUARDIAN
* UNITED GUARDIAN INC
RENACIDIN, CITRIC ACID
UNITED THERAP
* UNITED THERAPEUTICS CORP
ORENITRAM, TREPROSTINIL
REMODULIN, TREPROSTINIL
TYVASO, TREPROSTINIL
UNIV TX MD ANDERSON
* UNIV TEXAS MD ANDERSON CANCER CENTER
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
UPSHER SMITH
* UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DIVIGEL, ESTRADIOL
FORTICAL, CALCITONIN SALMON RECOMBINANT
LAMOTRIGINE, LAMOTRIGINE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MORPHINE SULFATE, MORPHINE SULFATE
NIACOR, NIACIN
NYSTATIN, NYSTATIN
ORVATEN, MIDODRINE HYDROCHLORIDE
OXANDROLONE, OXANDROLONE
PACERONE, AMIODARONE HYDROCHLORIDE
PREVALITE, CHOLESTYRAMINE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
SORINE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
ZALEPLON, ZALEPLON
UPSHER SMITH LABS
* UPSHER SMITH LABORATORIES INC
KLOR-CON M10, POTASSIUM CHLORIDE
KLOR-CON M15, POTASSIUM CHLORIDE
KLOR-CON M20, POTASSIUM CHLORIDE
B - 115
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
U
**
UPSHER-SMITH LABS
* UPSHER-SMITH LABORATORIES INC
KLOR-CON, POTASSIUM CHLORIDE
US PHARMS HOLDINGS I
* US PHARMACEUTICALS HOLDINGS I LLC
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
METHERGINE, METHYLERGONOVINE MALEATE
PARLODEL, BROMOCRIPTINE MESYLATE
US WORLDMEDS
* US WORLDMEDS LLC
APOKYN, APOMORPHINE HYDROCHLORIDE
DANTROLENE SODIUM, DANTROLENE SODIUM
USL PHARMA
* USL PHARMA INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
ESTRADIOL, ESTRADIOL
FLUOXYMESTERONE, FLUOXYMESTERONE
JANTOVEN, WARFARIN SODIUM
**
V
**
VALEANT
* VALEANT PHARMACEUTICALS INTERNATIONAL
ANCOBON, FLUCYTOSINE
BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BONTRIL, PHENDIMETRAZINE TARTRATE
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MOTOFEN, ATROPINE SULFATE
MYSOLINE, PRIMIDONE
PHRENILIN FORTE, ACETAMINOPHEN
PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN
VALEANT BERMUDA
* VALEANT INTERNATIONAL BERMUDA
APLENZIN, BUPROPION HYDROBROMIDE
BENZACLIN, BENZOYL PEROXIDE
CARAC, FLUOROURACIL
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
ELIDEL, PIMECROLIMUS
ISORDIL, ISOSORBIDE DINITRATE
KLARON, SULFACETAMIDE SODIUM
NORITATE, METRONIDAZOLE
PENLAC, CICLOPIROX
RETIN-A, TRETINOIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
XENAZINE, TETRABENAZINE
XERESE, ACYCLOVIR
ZOVIRAX, ACYCLOVIR
VALEANT INTL
* VALEANT INTERNATIONAL BARBADOS SRL
ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
FENOFIBRATE, FENOFIBRATE
NIFEDIPINE, NIFEDIPINE
PENTOXIFYLLINE, PENTOXIFYLLINE
B - 116
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
V
**
* VALEANT INTERNATIONAL BARBADOS SRL
RENOVA, TRETINOIN
RETIN-A MICRO, TRETINOIN
RETIN-A, TRETINOIN
TIAZAC, DILTIAZEM HYDROCHLORIDE
ULTRAM ER, TRAMADOL HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOTEC, ENALAPRIL MALEATE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
* VALEANT INTERNATIONAL SRL
BENZAMYCIN, BENZOYL PEROXIDE
VALEANT LUXEMBOURG
* VALEANT PHARMACEUTICALS LUXEMBOURG SARL
BENZAMYCIN PAK, BENZOYL PEROXIDE
ERTACZO, SERTACONAZOLE NITRATE
GRIFULVIN V, GRISEOFULVIN, MICROSIZE
TARGRETIN, BEXAROTENE
VALEANT PHARM INTL
* VALEANT PHARMACEUTICALS INTERNATIONAL
ANDROID 10, METHYLTESTOSTERONE
ANDROID 25, METHYLTESTOSTERONE
EFUDEX, FLUOROURACIL
TESTRED, METHYLTESTOSTERONE
ZELAPAR, SELEGILINE HYDROCHLORIDE
VALEANT PHARMS
* VALEANT PHARMACEUTICALS NORTH AMERICA
MEPHYTON, PHYTONADIONE
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
VALEANT PHARMS INC
* VALEANT PHARMACEUTICALS INTERNATIONAL INC
VISUDYNE, VERTEPORFIN
VALEANT PHARMS LLC
* VALEANT PHARMACEUTICALS NORTH AMERICA LLC
CAPITAL AND CODEINE, ACETAMINOPHEN
MACUGEN, PEGAPTANIB SODIUM
MESTINON, PYRIDOSTIGMINE BROMIDE
TASMAR, TOLCAPONE
TIMOPTIC-XE, TIMOLOL MALEATE
VALIDUS PHARMS
* VALIDUS PHARMACEUTICALS LLC
ROCALTROL, CALCITRIOL
VALIDUS PHARMS INC
* VALIDUS PHARMACEUTICALS INC
EQUETRO, CARBAMAZEPINE
MARPLAN, ISOCARBOXAZID
VANSEN PHARMA
* VANSEN PHARMA
SPECTRACEF, CEFDITOREN PIVOXIL
VEROSCIENCE
* VEROSCIENCE LLC
CYCLOSET, BROMOCRIPTINE MESYLATE
VERSAPHARM
* VERSAPHARM INC
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DESOXIMETASONE, DESOXIMETASONE
ERYTHROMYCIN, ERYTHROMYCIN
ETHOSUXIMIDE, ETHOSUXIMIDE
RIFAMPIN, RIFAMPIN
VERSAPHARM INC
* VERSAPHARM INC
RIFAMPIN, RIFAMPIN
B - 117
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
V
**
* VERSAPHARM INC
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
* VERSAPHARM INCORPORATED
TRANEXAMIC ACID, TRANEXAMIC ACID
VERTEX PHARMS
* VERTEX PHARMACEUTICALS INC
INCIVEK, TELAPREVIR
KALYDECO, IVACAFTOR
VESTIQ PHARMS
* VESTIQ PHARMACEUTICALS INC
ORAVIG, MICONAZOLE
ZUPLENZ, ONDANSETRON
VICURON
* VICURON PHARMACEUTICALS INC
ERAXIS, ANIDULAFUNGIN
VIFOR FRESENIUS
* VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
VELPHORO, SUCROFERRIC OXYHYDROXIDE
VIIV HLTHCARE
* VIIV HEALTHCARE CO
COMBIVIR, LAMIVUDINE
EPIVIR, LAMIVUDINE
EPZICOM, ABACAVIR SULFATE
LEXIVA, FOSAMPRENAVIR CALCIUM
RESCRIPTOR, DELAVIRDINE MESYLATE
RETROVIR, ZIDOVUDINE
SELZENTRY, MARAVIROC
TIVICAY, DOLUTEGRAVIR SODIUM
TRIZIVIR, ABACAVIR SULFATE
ZIAGEN, ABACAVIR SULFATE
VINTAGE
* VINTAGE PHARMACEUTICALS LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETIC ACID, ACETIC ACID, GLACIAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALPRAZOLAM, ALPRAZOLAM
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOLIC ACID, FOLIC ACID
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LISINOPRIL, LISINOPRIL
NYSTATIN, NYSTATIN
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE
RISPERIDONE, RISPERIDONE
SPIRONOLACTONE, SPIRONOLACTONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALPROIC ACID, VALPROIC ACID
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
B - 118
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
V
**
* VINTAGE PHARMACEUTICALS LLC
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
VINTAGE PHARMS
* VINTAGE PHARMACEUTICALS
DISULFIRAM, DISULFIRAM
GILDAGIA, ETHINYL ESTRADIOL
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
LEVETIRACETAM, LEVETIRACETAM
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
* VINTAGE PHARMACEUTICALS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALLOPURINOL, ALLOPURINOL
BACLOFEN, BACLOFEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
CLONAZEPAM, CLONAZEPAM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM, DIAZEPAM
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN
(OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LACTULOSE, LACTULOSE
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
METHOCARBAMOL, METHOCARBAMOL
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SULFASALAZINE, SULFASALAZINE
TORSEMIDE, TORSEMIDE
VINTAGE PHARMS LLC
* VINTAGE PHARMACEUTICALS LLC
CYCLAFEM 1/35, ETHINYL ESTRADIOL
CYCLAFEM 7/7/7, ETHINYL ESTRADIOL
EMOQUETTE, DESOGESTREL
FELODIPINE, FELODIPINE
GILDESS FE 1.5/30, ETHINYL ESTRADIOL
GILDESS FE 1/20, ETHINYL ESTRADIOL
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYZILRA, ETHINYL ESTRADIOL
ORSYTHIA, ETHINYL ESTRADIOL
PERCOCET, ACETAMINOPHEN
PREVIFEM, ETHINYL ESTRADIOL
TRI-PREVIFEM, ETHINYL ESTRADIOL
ZYDONE, ACETAMINOPHEN
B - 119
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
V
**
VIROPHARMA
* VIROPHARMA INC
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VIRTUS PHARM
* VIRTUS PHARMACEUTICAL INC
ACARBOSE , ACARBOSE
VISTA PHARMS
* VISTA PHARMACEUTICALS INC
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
VISTAPHARM
* VISTAPHARM INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LACTULOSE, LACTULOSE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NYSTATIN, NYSTATIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
VIVIMED LABS
* VIVIMED LABS ALATHUR PRIVATE LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
VIVUS
* VIVUS INC
QSYMIA, PHENTERMINE HYDROCHLORIDE
STENDRA, AVANAFIL
**
W
**
WARNER CHILCOTT
* WARNER CHILCOTT CO LLC
LO MINASTRIN FE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE,
* WARNER CHILCOTT INC
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
WARNER CHILCOTT LLC
* WARNER CHILCOTT CO LLC
ACTONEL, RISEDRONATE SODIUM
ASACOL HD, MESALAMINE
ASACOL, MESALAMINE
ATELVIA, RISEDRONATE SODIUM
CHOLEDYL SA, OXTRIPHYLLINE
DELZICOL, MESALAMINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ESTROSTEP FE, ETHINYL ESTRADIOL
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMTRACE, ESTRADIOL ACETATE
LO LOESTRIN FE, ETHINYL ESTRADIOL
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
MINASTRIN 24 FE, ETHINYL ESTRADIOL
OVCON-35, ETHINYL ESTRADIOL
SARAFEM, FLUOXETINE HYDROCHLORIDE
WARNER CHILCOTT US
* WARNER CHILCOTT US LLC
ESTRACE, ESTRADIOL
WARNER IRELAND
* WARNER CHILCOTT IRELAND LTD
FEMRING, ESTRADIOL ACETATE
WATSON LABS
ETHINYL ESTRADIOL
B - 120
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
* WATSON LABORATORIES
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN
ANASTROZOLE, ANASTROZOLE
FOLIC ACID, FOLIC ACID
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MICROGESTIN 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN 1/20, ETHINYL ESTRADIOL
MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN FE 1/20, ETHINYL ESTRADIOL
NORCO, ACETAMINOPHEN
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OXAPROZIN, OXAPROZIN
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* WATSON LABORATORIES INC
ACARBOSE, ACARBOSE
ACETOHEXAMIDE, ACETOHEXAMIDE
AFEDITAB CR, NIFEDIPINE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALORA, ESTRADIOL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXAPINE, AMOXAPINE
ANDRODERM, TESTOSTERONE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CABERGOLINE, CABERGOLINE
CARBOPLATIN, CARBOPLATIN
CHLORZOXAZONE, CHLORZOXAZONE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
COL-PROBENECID, COLCHICINE
CRINONE, PROGESTERONE
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
ERGOLOID MESYLATES, ERGOLOID MESYLATES
FENTANYL CITRATE, FENTANYL CITRATE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GELNIQUE, OXYBUTYNIN CHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ISRADIPINE, ISRADIPINE
LAMOTRIGINE, LAMOTRIGINE
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
B - 121
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
* WATSON LABORATORIES INC
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL
(OTC)
LISINOPRIL, LISINOPRIL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOW-OGESTREL-21, ETHINYL ESTRADIOL
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MEPROBAMATE, MEPROBAMATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METRONIDAZOLE, METRONIDAZOLE
MINOXIDIL, MINOXIDIL
MIRTAZAPINE, MIRTAZAPINE
NABUMETONE, NABUMETONE
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NATEGLINIDE, NATEGLINIDE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NICOTINE POLACRILEX, NICOTINE POLACRILEX
(OTC)
NIZATIDINE, NIZATIDINE
NORCO, ACETAMINOPHEN
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
OGESTREL 0.5/50-28, ETHINYL ESTRADIOL
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE, PREDNISOLONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
QUASENSE, ETHINYL ESTRADIOL
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL
RAPAFLO, SILODOSIN
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TACROLIMUS, TACROLIMUS
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TELMISARTAN, TELMISARTAN
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANDOLAPRIL, TRANDOLAPRIL
TRELSTAR, TRIPTORELIN PAMOATE
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
TRIVORA-28, ETHINYL ESTRADIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZOVIA 1/50E-28, ETHINYL ESTRADIOL
* WATSON LABS INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WATSON LABS (UTAH)
* WATSON LABORATORIES INC
INFED, IRON DEXTRAN
NOR-QD, NORETHINDRONE
B - 122
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
* WATSON LABORATORIES INC
OXYTROL, OXYBUTYNIN
PROGESTERONE, PROGESTERONE
WATSON LABS FLORIDA
* WATSON LABORATORIES INC FLORIDA
ALPRAZOLAM, ALPRAZOLAM
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
GLIMEPIRIDE, GLIMEPIRIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
LEVETIRACETAM, LEVETIRACETAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
RISPERIDONE, RISPERIDONE
WATSON LABS INC
* WATSON LABORATORIES INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMMONIUM LACTATE, AMMONIUM LACTATE
ARMODAFINIL, ARMODAFINIL
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CICLOPIROX, CICLOPIROX
CYCLOSPORINE, CYCLOSPORINE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
GELNIQUE 3%, OXYBUTYNIN
IBANDRONATE SODIUM, IBANDRONATE SODIUM
INDOMETHACIN, INDOMETHACIN
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
KADIAN, MORPHINE SULFATE
LAMOTRIGINE, LAMOTRIGINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL
(OTC)
LIDOCAINE, LIDOCAINE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
PREGABALIN, PREGABALIN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RASAGILINE MESYLATE, RASAGILINE MESYLATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
URSODIOL, URSODIOL
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WATSON LABS INC FL
* WATSON LABORATORIES INC FLORIDA
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
FLUTAMIDE, FLUTAMIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
WATSON PHARMS
* WATSON PHARMACEUTICALS
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
B - 123
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
* WATSON PHARMACEUTICALS INC
ACTIGALL, URSODIOL
WEILL MEDCL COLL
* WEILL MEDICAL COLLEGE CORNELL UNIV
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
WELLSPRING PHARM
* WELLSPRING PHARMACEUTICAL CORP
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DUVOID, BETHANECHOL CHLORIDE
WEST WARD
* WEST WARD INC
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
* WEST WARD PHARMACEUTICAL CORP
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE,
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CORTISONE ACETATE, CORTISONE ACETATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LITHIUM CARBONATE, LITHIUM CARBONATE
PRIMIDONE, PRIMIDONE
ZALEPLON, ZALEPLON
WEST WARD PHARM CORP
* WEST WARD PHARMACEUTICAL CORP
NAPROXEN, NAPROXEN
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
WEST WARD PHARMS
* WEST WARD PHARMACEUTICALS CORP
RISPERIDONE, RISPERIDONE
WEST-WARD PHARM CORP
* WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN, CEFOTETAN DISODIUM
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
WI MEDCL CYCLOTRON
* WISCONSIN MEDICAL CYCLOTRON LLC
FLUDEOXYGLUCOSE F-18, FLUDEOXYGLUCOSE F-18
WILSHIRE PHARMS INC
* WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE, LAMOTRIGINE
WOCKHARDT
* WOCKHARDT AMERICAS INC
FAMOTIDINE, FAMOTIDINE
* WOCKHARDT EU OPERATIONS (SWISS) AG
BROMFED-DM, BROMPHENIRAMINE MALEATE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
LEVETIRACETAM, LEVETIRACETAM
LINDANE, LINDANE
PHENYTOIN, PHENYTOIN
* WOCKHARDT LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AZITHROMYCIN, AZITHROMYCIN
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
ACETAMINOPHEN
B - 124
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
* WOCKHARDT LTD
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE
(OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMOTIDINE, FAMOTIDINE
(OTC)
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL, LISINOPRIL
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
(OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
WOCKHARDT EU OPERATN
* WOCKHARDT EU OPERATIONS SWISS AG
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
DEXAMETHASONE, DEXAMETHASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
WOCKHARDT LTD
* WOCKHARDT LTD
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
ENTACAPONE, ENTACAPONE
FELODIPINE, FELODIPINE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE
(OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE
(OTC)
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
(OTC)
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
WOCKHARDT USA
* WOCKHARDT USA INC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
* WOCKHARDT USA LLC
ENALAPRIL MALEATE, ENALAPRIL MALEATE
LANSOPRAZOLE, LANSOPRAZOLE
TOPIRAMATE, TOPIRAMATE
B - 125
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
W
**
WORLD GEN
* WORLD GEN LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
WRASER PHARMS
* WRASER PHARMACEUTICALS LLC
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
WYETH PHARMS
* WYETH PHARMACEUTICALS INC SUB PFIZER INC
LO/OVRAL-28, ETHINYL ESTRADIOL
WYETH PHARMS INC
* WYETH PHARMACEUTICALS INC
BOSULIF, BOSUTINIB MONOHYDRATE
CORDARONE, AMIODARONE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
INDERAL, PROPRANOLOL HYDROCHLORIDE
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PREMARIN, ESTROGENS, CONJUGATED
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
TRECATOR, ETHIONAMIDE
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM
ZOSYN, PIPERACILLIN SODIUM
WYETH PHARMS PFIZER
* WYETH PHARMACEUTICALS INC WHOLLY OWNED SUB PFIZER INC
DUAVEE, BAZEDOXIFENE ACETATE
**
X
**
X GEN PHARMS
* X GEN PHARMACEUTICALS INC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
AMPHOTERICIN B, AMPHOTERICIN B
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
HYDRO-RX, HYDROCORTISONE
LEVETIRACETAM, LEVETIRACETAM
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NYSTATIN, NYSTATIN
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
X-GEN PHARMS
* X-GEN PHARMACEUTICALS INC
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
X-GEN PHARMS INC
* X-GEN PHARMACEUTICALS INC
TRANEXAMIC ACID, TRANEXAMIC ACID
XELLIA PHARMS APS
* XELLIA PHARMACEUTICALS APS
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
XENOPORT INC
* XENOPORT INC
HORIZANT, GABAPENTIN ENACARBIL
XOMA
* XOMA (US) LLC
ACEON, PERINDOPRIL ERBUMINE
XSPIRE
* XSPIRE LLC
NALFON, FENOPROFEN CALCIUM
XTTRIUM
* XTTRIUM LABORATORIES INC
B - 126
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
* XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE,
X
**
CHLORHEXIDINE GLUCONATE
**
Y
**
Z
**
YUNG SHIN PHARM
* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFACLOR, CEFACLOR
CEPHALEXIN, CEPHALEXIN
**
ZACH SYSTEMS
* ZACH SYSTEMS SPA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
ZAMBON SPA
* ZAMBON SPA ITALY
MONUROL, FOSFOMYCIN TROMETHAMINE
ZOGENIX INC
* ZOGENIX INC
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
ZOHYDRO ER, HYDROCODONE BITARTRATE
ZYDUS HLTHCARE
* ZYDUS HEALTHCARE USA LLC
LANSOPRAZOLE, LANSOPRAZOLE
ZYDUS PHARMS USA
* ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
AZATHIOPRINE, AZATHIOPRINE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BENZONATATE, BENZONATATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
LAMOTRIGINE, LAMOTRIGINE
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN, NAPROXEN
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
ZONISAMIDE, ZONISAMIDE
ZYDUS PHARMS USA INC
* ZYDUS PHARMACEUTICALS USA INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
CARVEDILOL, CARVEDILOL
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ETHOSUXIMIDE, ETHOSUXIMIDE
FINASTERIDE, FINASTERIDE
B - 127
DECEMBER 2013 - APPROVED DRUG PRODUCT LIST
APPENDIX B
-
PRODUCT NAME SORTED BY APPLICANT
**
Z
**
* ZYDUS PHARMACEUTICALS USA INC
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
INDOMETHACIN, INDOMETHACIN
IRBESARTAN, IRBESARTAN
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
OMEPRAZOLE, OMEPRAZOLE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SIROLIMUS, SIROLIMUS
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
B - 128
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