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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2014

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on October 08, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/03/2014 PEPCID
NDA #019462		 SUPPL-38 FAMOTIDINE BAUSCH Labeling Approval
02/03/2014 TRUSOPT
NDA #020408		 SUPPL-50 DORZOLAMIDE HYDROCHLORIDE MSD SUB MERCK Labeling Approval
02/03/2014 ELIGARD KIT
NDA #021379		 SUPPL-27 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
02/03/2014 LUNESTA
NDA #021476		 SUPPL-28 ESZOPICLONE WAYLIS THERAP Labeling Approval
02/03/2014 MODAFINIL
ANDA #077667		 ORIG-1 MODAFINIL APOTEX Approval
02/03/2014 GLYCOPYRROLATE
ANDA #091182		 ORIG-1 GLYCOPYRROLATE REGCON HOLDINGS Approval
02/03/2014 SELFEMRA
ANDA #200151		 ORIG-1 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Approval
02/03/2014 LAMIVUDINE AND ZIDOVUDINE
ANDA #203259		 ORIG-1 LAMIVUDINE; ZIDOVUDINE HETERO LABS LTD V Approval
02/03/2014 PRIMAQUINE PHOSPHATE
ANDA #203924		 ORIG-1 PRIMAQUINE PHOSPHATE ALVOGEN Approval
02/03/2014 EPANED KIT
NDA #204308		 SUPPL-1 ENALAPRIL MALEATE AZURITY Manufacturing (CMC) Approval
02/04/2014 SANDOSTATIN
NDA #019667		 SUPPL-59 OCTREOTIDE ACETATE NOVARTIS Manufacturing (CMC) Approval
02/04/2014 EXTRANEAL
NDA #021321		 SUPPL-30 ICODEXTRIN VANTIVE US HLTHCARE Manufacturing (CMC) Approval
02/04/2014 OXYCONTIN
NDA #022272		 SUPPL-15 OXYCODONE HYDROCHLORIDE KNOA PHARMA Manufacturing (CMC) Approval
02/04/2014 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076345		 SUPPL-26 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX Labeling Approval
02/04/2014 SIMPONI ARIA
BLA #125433		 SUPPL-2 GOLIMUMAB JANSSEN BIOTECH Approval
02/04/2014 DOXERCALCIFEROL
ANDA #200926		 ORIG-1 DOXERCALCIFEROL CAPLIN Approval
02/04/2014 FLUDEOXYGLUCOSE F18
ANDA #203664		 ORIG-1 FLUDEOXYGLUCOSE F-18 PHARMALOGIC HLDGS Approval
02/04/2014 LAMIVUDINE; ZIDOVUDINE
NDA #204914		 ORIG-1 LAMIVUDINE; ZIDOVUDINE MYLAN LABS Type 5 - New Formulation or New Manufacturer Tentative Approval
02/05/2014 PYLERA
NDA #050786		 SUPPL-11 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Manufacturing (CMC) Approval
02/05/2014 CEFTRIAXONE
ANDA #065169		 SUPPL-22 CEFTRIAXONE SODIUM SANDOZ Labeling Approval
02/05/2014 CEFPODOXIME PROXETIL
ANDA #065462		 SUPPL-5 CEFPODOXIME PROXETIL SANDOZ Labeling Approval
02/05/2014 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-6 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/05/2014 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-7 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/05/2014 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-8 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/05/2014 MORPHINE SULFATE
ANDA #201011		 ORIG-1 MORPHINE SULFATE SANKALP LIFECARE Approval
02/05/2014 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #201108		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL AMNEAL PHARMS Approval
02/05/2014 DISULFIRAM
ANDA #202652		 ORIG-1 DISULFIRAM HIKMA PHARMS Approval
02/05/2014 PHENTERMINE HYDROCHLORIDE
ANDA #202846		 ORIG-1 PHENTERMINE HYDROCHLORIDE INVAGEN PHARMS Approval
02/05/2014 PHENTERMINE HYDROCHLORIDE
ANDA #202942		 ORIG-1 PHENTERMINE HYDROCHLORIDE INVAGEN PHARMS Approval
02/05/2014 ILEVRO
NDA #203491		 SUPPL-3 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
02/05/2014 FLUDEOXYGLUCOSE F18
ANDA #203935		 ORIG-1 FLUDEOXYGLUCOSE F-18 WUSM CYCLOTRON Approval
02/05/2014 FLUDEOXYGLUCOSE F18
ANDA #203946		 ORIG-1 FLUDEOXYGLUCOSE F-18 ESSENTIAL ISOTOPES Approval
02/06/2014 IMURAN
NDA #016324		 SUPPL-37 AZATHIOPRINE LEGACY Labeling Approval
02/06/2014 ANADROL-50
NDA #016848		 SUPPL-23 OXYMETHOLONE PHARMOBEDIENT Manufacturing (CMC) Approval
02/06/2014 IMURAN
NDA #017391		 SUPPL-16 AZATHIOPRINE SODIUM CASPER PHARMA LLC Labeling Approval
02/06/2014 CISPLATIN
NDA #018057		 SUPPL-82 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/06/2014 PLATINOL
NDA #018057		 SUPPL-82 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/06/2014 PLATINOL-AQ
NDA #018057		 SUPPL-82 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/06/2014 BUPRENEX
NDA #018401		 SUPPL-18 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
02/06/2014 ALOXI
NDA #021372		 SUPPL-17 PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
02/06/2014 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE PH HEALTH Approval
02/06/2014 ZELBORAF
NDA #202429		 SUPPL-5 VEMURAFENIB HOFFMANN LA ROCHE Labeling Approval
02/07/2014 RITALIN
NDA #010187		 SUPPL-76 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/07/2014 ETHAMOLIN
NDA #019357		 SUPPL-18 ETHANOLAMINE OLEATE QOL MEDCL Manufacturing (CMC) Approval
02/07/2014 AGRYLIN
NDA #020333		 SUPPL-21 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
02/07/2014 VIBATIV
NDA #022110		 SUPPL-7 TELAVANCIN HYDROCHLORIDE APOTEX Labeling Approval
02/07/2014 OZURDEX
NDA #022315		 SUPPL-8 DEXAMETHASONE ABBVIE Labeling Approval
02/07/2014 CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796		 SUPPL-18 CEFTRIAXONE SODIUM B BRAUN Manufacturing (CMC) Approval
02/07/2014 LEVORA 0.15/30-28
ANDA #073594		 SUPPL-24 ETHINYL ESTRADIOL; LEVONORGESTREL DR REDDYS LABS SA Labeling Approval
02/07/2014 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-26 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
02/07/2014 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-27 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
02/07/2014 BUSPIRONE HYDROCHLORIDE
ANDA #078888		 ORIG-1 BUSPIRONE HYDROCHLORIDE ZYDUS PHARMS Approval
02/07/2014 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-6 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
02/07/2014 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-9 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
02/07/2014 VICTRELIS
NDA #202258		 SUPPL-13 BOCEPREVIR MERCK SHARP DOHME Labeling Approval
02/07/2014 ZYTIGA
NDA #202379		 SUPPL-8 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
02/07/2014 ZOLEDRONIC ACID
NDA #203231		 SUPPL-1 ZOLEDRONIC ACID INFORLIFE Manufacturing (CMC) Approval
02/07/2014 AMMONIA N 13
ANDA #204506		 ORIG-1 AMMONIA N-13 WA UNIV SCH MED Approval
02/09/2014 VIVITROL
NDA #021897		 SUPPL-24 NALTREXONE ALKERMES Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 12
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 140
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 180
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 210
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 240
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 300
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 350
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 70
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 OMNIPAQUE 9
NDA #018956		 SUPPL-91 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
02/10/2014 ZAVESCA
NDA #021348		 SUPPL-10 MIGLUSTAT ACTELION Labeling Approval
02/10/2014 PROMACTA
NDA #022291		 SUPPL-10 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
02/10/2014 SERTRALINE HYDROCHLORIDE
ANDA #077864		 SUPPL-1 SERTRALINE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
02/10/2014 NPLATE
BLA #125268		 SUPPL-141 ROMIPLOSTIM AMGEN Approval
02/10/2014 RAYOS
NDA #202020		 SUPPL-6 PREDNISONE HORIZON Manufacturing (CMC) Approval
02/10/2014 CLOPIDOGREL BISULFATE
ANDA #202928		 ORIG-1 CLOPIDOGREL BISULFATE MACLEODS PHARMS Approval
02/10/2014 KETOROLAC TROMETHAMINE
ANDA #203376		 ORIG-1 KETOROLAC TROMETHAMINE EPIC PHARMA LLC Approval
02/10/2014 SYNRIBO
NDA #203585		 SUPPL-1 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Efficacy Approval
02/11/2014 MONISTAT-DERM
NDA #017494		 SUPPL-40 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing (CMC) Approval
02/11/2014 MONISTAT-DERM
NDA #017494		 SUPPL-65 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 3
NDA #018888		 SUPPL-17 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 EDEX
NDA #020649		 SUPPL-21 ALPROSTADIL ENDO OPERATIONS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 3 COMBINATION PACK
NDA #020670		 SUPPL-24 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 3
NDA #020827		 SUPPL-23 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 MONISTAT DUAL- PAK
NDA #020968		 SUPPL-5 MICONAZOLE NITRATE PERSONAL PRODS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 3 COMBINATION PACK
NDA #021261		 SUPPL-16 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261		 SUPPL-16 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 MONISTAT 1 COMBINATION PACK
NDA #021308		 SUPPL-21 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/11/2014 VITRASE
BLA #021640		 SUPPL-22 HYALURONIDASE BAUSCH AND LOMB Approval
02/11/2014 VPRIV
BLA #022575		 SUPPL-8 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
02/11/2014 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-7 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
02/11/2014 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-8 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
02/11/2014 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-9 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
02/11/2014 TRANEXAMIC ACID
ANDA #202436		 ORIG-1 TRANEXAMIC ACID HERITAGE Approval
02/11/2014 RIZATRIPTAN BENZOATE
ANDA #203147		 ORIG-1 RIZATRIPTAN BENZOATE MACLEODS PHARMS Approval
02/11/2014 ASTAGRAF XL
NDA #204096		 SUPPL-1 TACROLIMUS ASTELLAS Labeling Approval
02/11/2014 ACETYLCYSTEINE
ANDA #204674		 ORIG-1 ACETYLCYSTEINE ALVOGEN Approval
02/12/2014 TECHNELITE
NDA #017771		 SUPPL-35 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR SHINE Labeling Approval
02/12/2014 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018800		 SUPPL-26 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
02/12/2014 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018803		 SUPPL-27 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
02/12/2014 SODIUM CHLORIDE 14.6%
NDA #018897		 SUPPL-27 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
02/12/2014 SODIUM CHLORIDE 23.4%
NDA #018897		 SUPPL-27 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
02/12/2014 RENACIDIN
NDA #019481		 SUPPL-11 CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE UNITED GUARDIAN Manufacturing (CMC) Approval
02/12/2014 CUROSURF
BLA #020744		 SUPPL-27 PORACTANT ALFA CHIESI USA INC Approval
02/12/2014 CHLORAPREP ONE-STEP
NDA #020832		 SUPPL-33 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
02/12/2014 CHLORAPREP ONE-STEP FREPP
NDA #020832		 SUPPL-33 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
02/12/2014 CHLORAPREP WITH TINT
NDA #020832		 SUPPL-33 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
02/12/2014 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-11 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
02/12/2014 FLUORESCITE
NDA #021980		 SUPPL-5 FLUORESCEIN SODIUM ALCON LABS INC Manufacturing (CMC) Approval
02/12/2014 TIMENTIN
NDA #050590		 SUPPL-68 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
02/12/2014 SIMPONI ARIA
BLA #125433		 SUPPL-5 GOLIMUMAB JANSSEN BIOTECH Approval
02/12/2014 ISOPTO CARPINE
NDA #200890		 SUPPL-6 PILOCARPINE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/12/2014 TEMOZOLOMIDE
ANDA #201742		 ORIG-1 TEMOZOLOMIDE SUN PHARM Approval
02/12/2014 JANUMET XR
NDA #202270		 SUPPL-6 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
02/12/2014 XARELTO
NDA #202439		 SUPPL-12 RIVAROXABAN JANSSEN PHARMS REMS Approval
02/12/2014 IMBRUVICA
NDA #205552		 ORIG-2 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
02/13/2014 CHILDREN'S ADVIL
NDA #020944		 SUPPL-10 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/13/2014 JUNIOR STRENGTH ADVIL
NDA #020944		 SUPPL-10 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/13/2014 XARELTO
NDA #022406		 SUPPL-10 RIVAROXABAN JANSSEN PHARMS Labeling Approval
02/13/2014 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422		 SUPPL-33 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
02/13/2014 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
02/13/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-2 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/13/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-4 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/13/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-5 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/13/2014 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-6 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/13/2014 LIPTRUZET
NDA #200153		 SUPPL-2 ATORVASTATIN CALCIUM; EZETIMIBE ORGANON Manufacturing (CMC) Approval
02/13/2014 VASCEPA
NDA #202057		 SUPPL-6 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
02/13/2014 ILEVRO
NDA #203491		 SUPPL-4 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
02/14/2014 SEPTOCAINE
NDA #020971		 SUPPL-29 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DEPROCO Manufacturing (CMC) Approval
02/14/2014 NEXIUM
NDA #021153		 SUPPL-48 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Manufacturing (CMC) Approval
02/14/2014 AEROSPAN HFA
NDA #021247		 SUPPL-11 FLUNISOLIDE PHARMOBEDIENT Manufacturing (CMC) Approval
02/14/2014 STALEVO 100
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 STALEVO 125
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 STALEVO 150
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 STALEVO 200
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 STALEVO 50
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 STALEVO 75
NDA #021485		 SUPPL-32 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/14/2014 XYZAL
NDA #022064		 SUPPL-27 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
02/14/2014 XYZAL
NDA #022157		 SUPPL-11 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
02/14/2014 NICORETTE
NDA #022360		 SUPPL-8 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
02/14/2014 OMEPRAZOLE MAGNESIUM
ANDA #078878		 SUPPL-15 OMEPRAZOLE MAGNESIUM DR REDDYS LABS LTD Manufacturing (CMC) Approval
02/14/2014 IBANDRONATE SODIUM
ANDA #090853		 ORIG-1 IBANDRONATE SODIUM SUN PHARM Approval
02/14/2014 VIMIZIM
BLA #125460		 ORIG-1 ELOSULFASE ALFA BIOMARIN PHARM Approval
02/14/2014 XALKORI
NDA #202570		 SUPPL-10 CRIZOTINIB PF PRISM CV Manufacturing (CMC) Approval
02/14/2014 FYCOMPA
NDA #202834		 SUPPL-4 PERAMPANEL CATALYST PHARMS Labeling Approval
02/14/2014 PHENTERMINE HYDROCHLORIDE
ANDA #202858		 ORIG-1 PHENTERMINE HYDROCHLORIDE INVAGEN PHARMS Approval
02/18/2014 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-43 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Labeling Approval
02/18/2014 SORIATANE
NDA #019821		 SUPPL-22 ACITRETIN STIEFEL LABS INC Labeling Approval
02/18/2014 ZYPREXA RELPREVV
NDA #022173		 SUPPL-20 OLANZAPINE PAMOATE CHEPLAPHARM Manufacturing (CMC) Approval
02/18/2014 MOXIFLOXACIN HYDROCHLORIDE
ANDA #077437		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE TEVA PHARMS USA Approval
02/18/2014 CARBOPLATIN
ANDA #077926		 SUPPL-1 CARBOPLATIN SUN PHARM Manufacturing (CMC) Approval
02/18/2014 LEVETIRACETAM
ANDA #091399		 SUPPL-2 LEVETIRACETAM LUPIN LTD Labeling Approval
02/18/2014 LEVETIRACETAM
ANDA #091399		 SUPPL-6 LEVETIRACETAM LUPIN LTD Labeling Approval
02/18/2014 SUPRENZA
NDA #202088		 SUPPL-7 PHENTERMINE HYDROCHLORIDE CITIUS PHARMS Manufacturing (CMC) Approval
02/18/2014 NORTHERA
NDA #203202		 ORIG-1 DROXIDOPA LUNDBECK NA LTD Type 1 - New Molecular Entity Approval
02/18/2014 JUXTAPID
NDA #203858		 SUPPL-6 LOMITAPIDE MESYLATE CHIESI Labeling Approval
02/19/2014 BRAVELLE
BLA #021289		 SUPPL-19 UROFOLLITROPIN FERRING Approval
02/19/2014 MENOPUR
BLA #021663		 SUPPL-14 MENOTROPINS (FSH;LH) FERRING Approval
02/19/2014 BACTOCILL IN PLASTIC CONTAINER
NDA #050640		 SUPPL-9 OXACILLIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
02/19/2014 GUANFACINE HYDROCHLORIDE
ANDA #075109		 SUPPL-5 GUANFACINE HYDROCHLORIDE AMNEAL PHARM Manufacturing (CMC) Approval
02/19/2014 CARBAMAZEPINE
ANDA #075712		 SUPPL-23 CARBAMAZEPINE TORRENT PHARMS Labeling Approval
02/19/2014 CARBAMAZEPINE
ANDA #075712		 SUPPL-24 CARBAMAZEPINE TORRENT PHARMS Labeling Approval
02/19/2014 CARBAMAZEPINE
ANDA #077272		 SUPPL-12 CARBAMAZEPINE TORRENT PHARMS Labeling Approval
02/19/2014 CARBAMAZEPINE
ANDA #077272		 SUPPL-13 CARBAMAZEPINE TORRENT PHARMS Labeling Approval
02/19/2014 KETOTIFEN FUMARATE
ANDA #077958		 SUPPL-11 KETOTIFEN FUMARATE SENTISS Manufacturing (CMC) Approval
02/19/2014 DIVALPROEX SODIUM
ANDA #079163		 SUPPL-1 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
02/19/2014 DIVALPROEX SODIUM
ANDA #079163		 SUPPL-3 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
02/19/2014 DIVALPROEX SODIUM
ANDA #079163		 SUPPL-5 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
02/19/2014 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #088763		 SUPPL-83 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
02/19/2014 COLISTIMETHATE SODIUM
ANDA #201365		 ORIG-1 COLISTIMETHATE SODIUM SAGENT PHARMS INC Approval
02/20/2014 PARAGARD T 380A
NDA #018680		 SUPPL-68 COPPER COOPERSURGICAL Manufacturing (CMC) Approval
02/20/2014 NICODERM CQ
NDA #020165		 SUPPL-26 NICOTINE CHATTEM SANOFI Manufacturing (CMC) Approval
02/20/2014 COZAAR
NDA #020386		 SUPPL-59 LOSARTAN POTASSIUM ORGANON Manufacturing (CMC) Approval
02/20/2014 STRATTERA
NDA #021411		 SUPPL-44 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
02/20/2014 HEPSERA
NDA #021449		 SUPPL-22 ADEFOVIR DIPIVOXIL GILEAD Manufacturing (CMC) Approval
02/20/2014 EMTRIVA
NDA #021896		 SUPPL-21 EMTRICITABINE GILEAD Manufacturing (CMC) Approval
02/20/2014 AFINITOR
NDA #022334		 SUPPL-21 EVEROLIMUS NOVARTIS Labeling Approval
02/20/2014 AFINITOR
NDA #022334		 SUPPL-23 EVEROLIMUS NOVARTIS Labeling Approval
02/20/2014 AFINITOR
NDA #022334		 SUPPL-24 EVEROLIMUS NOVARTIS Labeling Approval
02/20/2014 HEPARIN SODIUM
ANDA #090808		 SUPPL-10 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
02/20/2014 CLONIDINE HYDROCHLORIDE
ANDA #202601		 ORIG-1 CLONIDINE HYDROCHLORIDE ZYDUS PHARMS Approval
02/20/2014 AFINITOR DISPERZ
NDA #203985		 SUPPL-2 EVEROLIMUS NOVARTIS PHARM Labeling Approval
02/20/2014 AFINITOR DISPERZ
NDA #203985		 SUPPL-4 EVEROLIMUS NOVARTIS PHARM Labeling Approval
02/20/2014 AFINITOR DISPERZ
NDA #203985		 SUPPL-5 EVEROLIMUS NOVARTIS PHARM Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-14 CARBIDOPA ATON Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-16 CARBIDOPA ATON Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-17 CARBIDOPA ATON Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-18 CARBIDOPA ATON Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-19 CARBIDOPA ATON Labeling Approval
02/21/2014 LODOSYN
NDA #017830		 SUPPL-30 CARBIDOPA ATON Labeling Approval
02/21/2014 TECHNETIUM TC-99M MEDRONATE KIT
NDA #018107		 SUPPL-12 TECHNETIUM TC-99M MEDRONATE KIT CARDINAL HEALTH 414 Manufacturing (CMC) Approval
02/21/2014 CIS-MDP
NDA #018124		 SUPPL-23 TECHNETIUM TC-99M MEDRONATE KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
02/21/2014 NICORETTE
NDA #018612		 SUPPL-71 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
02/21/2014 NICORETTE (MINT)
NDA #018612		 SUPPL-71 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
02/21/2014 STRATTERA
NDA #021411		 SUPPL-43 ATOMOXETINE HYDROCHLORIDE LILLY Manufacturing (CMC) Approval
02/21/2014 ANTHELIOS 20
NDA #021471		 SUPPL-8 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE LOREAL USA Manufacturing (CMC) Approval
02/21/2014 CAPITAL SOLEIL 15
NDA #021501		 SUPPL-9 AVOBENZONE; ECAMSULE; OCTOCRYLENE LOREAL USA Manufacturing (CMC) Approval
02/21/2014 ANTHELIOS SX
NDA #021502		 SUPPL-14 AVOBENZONE; ECAMSULE; OCTOCRYLENE LOREAL USA Manufacturing (CMC) Approval
02/21/2014 ANTHELIOS 40
NDA #022009		 SUPPL-7 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE LOREAL USA Manufacturing (CMC) Approval
02/21/2014 SOMATULINE DEPOT
NDA #022074		 SUPPL-7 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
02/21/2014 ZYRTEC ALLERGY
NDA #022578		 SUPPL-4 CETIRIZINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
02/21/2014 CLAFORAN
NDA #050547		 SUPPL-70 CEFOTAXIME SODIUM STERIMAX Labeling Approval
02/21/2014 CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-40 CEFOTAXIME SODIUM STERIMAX Labeling Approval
02/21/2014 CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #050596		 SUPPL-40 CEFOTAXIME SODIUM STERIMAX Labeling Approval
02/21/2014 PORTIA-21
ANDA #075866		 SUPPL-23 ETHINYL ESTRADIOL; LEVONORGESTREL BARR Labeling Approval
02/21/2014 PORTIA-28
ANDA #075866		 SUPPL-23 ETHINYL ESTRADIOL; LEVONORGESTREL BARR Labeling Approval
02/21/2014 HEPARIN SODIUM
ANDA #090809		 SUPPL-5 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
02/21/2014 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810		 SUPPL-5 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
02/21/2014 IMIPRAMINE PAMOATE
ANDA #091099		 SUPPL-2 IMIPRAMINE PAMOATE HIKMA PHARMS Labeling Approval
02/21/2014 PREGABALIN
ANDA #203022		 ORIG-1 PREGABALIN APOTEX INC Tentative Approval
02/21/2014 KALYDECO
NDA #203188		 SUPPL-4 IVACAFTOR VERTEX PHARMS Efficacy Approval
02/21/2014 XELJANZ
NDA #203214		 SUPPL-4 TOFACITINIB CITRATE PF PRISM CV Efficacy Approval
02/23/2014 OPANA ER
NDA #021610		 SUPPL-17 OXYMORPHONE HYDROCHLORIDE ENDO OPERATIONS Manufacturing (CMC) Approval
02/24/2014 ZYRTEC ALLERGY
NDA #022578		 SUPPL-3 CETIRIZINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
02/24/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #040220		 SUPPL-30 METHYLPHENIDATE HYDROCHLORIDE WATSON LABS Labeling Approval
02/24/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #040220		 SUPPL-31 METHYLPHENIDATE HYDROCHLORIDE WATSON LABS Labeling Approval
02/24/2014 FLUOXETINE HYDROCHLORIDE
ANDA #078619		 SUPPL-5 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
02/24/2014 RIFABUTIN
ANDA #090033		 ORIG-1 RIFABUTIN LUPIN Approval
02/24/2014 HEPARIN SODIUM
ANDA #090571		 SUPPL-13 HEPARIN SODIUM HOSPIRA INC Labeling Approval
02/24/2014 MYALEPT
BLA #125390		 ORIG-1 METRELEPTIN CHIESI FARMACEUTICI SPA Approval
02/24/2014 VICTRELIS
NDA #202258		 SUPPL-14 BOCEPREVIR MERCK SHARP DOHME Labeling Approval
02/24/2014 AZITHROMYCIN
ANDA #202308		 ORIG-1 AZITHROMYCIN SANDOZ INC Tentative Approval
02/24/2014 JUVISYNC
NDA #202343		 SUPPL-11 SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/24/2014 FYCOMPA
NDA #202834		 SUPPL-3 PERAMPANEL CATALYST PHARMS Labeling Approval
02/24/2014 TIVORBEX
NDA #204768		 ORIG-1 INDOMETHACIN GENUS Type 3 - New Dosage Form Approval
02/25/2014 CONRAY
NDA #013295		 SUPPL-65 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
02/25/2014 CONRAY 43
NDA #013295		 SUPPL-65 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
02/25/2014 NIZORAL
NDA #018533		 SUPPL-41 KETOCONAZOLE JANSSEN PHARMS Labeling Approval
02/25/2014 BILTRICIDE
NDA #018714		 SUPPL-13 PRAZIQUANTEL BAYER HLTHCARE Labeling Approval
02/25/2014 PRILOSEC
NDA #019810		 SUPPL-99 OMEPRAZOLE ASTRAZENECA Labeling Approval
02/25/2014 NOVOLOG
BLA #020986		 SUPPL-75 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-75 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-75 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 NOVOLOG INNOLET
BLA #020986		 SUPPL-75 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 NOVOLOG PENFILL
BLA #020986		 SUPPL-75 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 NEXIUM
NDA #021153		 SUPPL-49 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
02/25/2014 EXTRANEAL
NDA #021321		 SUPPL-29 ICODEXTRIN VANTIVE US HLTHCARE REMS Approval
02/25/2014 LEVEMIR
BLA #021536		 SUPPL-48 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-48 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-48 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 LEVEMIR INNOLET
BLA #021536		 SUPPL-48 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 LEVEMIR PENFILL
BLA #021536		 SUPPL-48 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2014 ZEGERID
NDA #021636		 SUPPL-15 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
02/25/2014 NEXIUM IV
NDA #021689		 SUPPL-28 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
02/25/2014 ZEGERID
NDA #021849		 SUPPL-9 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
02/25/2014 NEXIUM
NDA #021957		 SUPPL-16 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
02/25/2014 PRILOSEC
NDA #022056		 SUPPL-15 OMEPRAZOLE MAGNESIUM AZURITY Labeling Approval
02/25/2014 NEXIUM
NDA #022101		 SUPPL-13 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
02/25/2014 VIMOVO
NDA #022511		 SUPPL-12 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
02/25/2014 ZOSYN
NDA #050684		 SUPPL-81 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Manufacturing (CMC) Approval
02/25/2014 ALTAVERA
ANDA #079102		 SUPPL-6 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
02/25/2014 BENZTROPINE MESYLATE
ANDA #090287		 SUPPL-4 BENZTROPINE MESYLATE HIKMA FARMACEUTICA Labeling Approval
02/25/2014 BRIELLYN
ANDA #090538		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
02/25/2014 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091648		 ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN NATCO Approval
02/25/2014 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201192		 ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN TORRENT Approval
02/25/2014 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010		 ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN ALEMBIC Approval
02/25/2014 PRIMAQUINE PHOSPHATE
ANDA #204476		 ORIG-1 PRIMAQUINE PHOSPHATE UNICHEM Approval
02/26/2014 KETEK
NDA #021144		 SUPPL-17 TELITHROMYCIN SANOFI AVENTIS US Manufacturing (CMC) Approval
02/26/2014 REYATAZ
NDA #021567		 SUPPL-34 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
02/26/2014 TACLONEX
NDA #022185		 SUPPL-17 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
02/26/2014 TACLONEX
NDA #022185		 SUPPL-17 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
02/26/2014 ZIRGAN
NDA #022211		 SUPPL-4 GANCICLOVIR BAUSCH AND LOMB Manufacturing (CMC) Approval
02/26/2014 CYCLOSPORINE
ANDA #065040		 SUPPL-8 CYCLOSPORINE APOTEX Labeling Approval
02/26/2014 CYCLOSPORINE
ANDA #065040		 SUPPL-9 CYCLOSPORINE APOTEX Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-38 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-39 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076113		 SUPPL-26 HYDROCHLOROTHIAZIDE; LISINOPRIL PHARMOBEDIENT Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194		 SUPPL-34 HYDROCHLOROTHIAZIDE; LISINOPRIL WATSON LABS Labeling Approval
02/26/2014 OFLOXACIN
ANDA #076513		 SUPPL-10 OFLOXACIN APOTEX INC Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-12 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-13 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
02/26/2014 FINASTERIDE
ANDA #077578		 SUPPL-11 FINASTERIDE MYLAN Manufacturing (CMC) Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-9 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-11 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-12 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-13 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-14 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-15 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-17 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
02/26/2014 HUMIRA
BLA #125057		 SUPPL-355 ADALIMUMAB ABBVIE INC Approval
02/26/2014 VASCEPA
NDA #202057		 SUPPL-8 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
02/26/2014 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA #202509		 ORIG-1 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE PH HEALTH Approval
02/27/2014 MONISTAT 7
NDA #017450		 SUPPL-66 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/27/2014 PARLODEL
NDA #017962		 SUPPL-72 BROMOCRIPTINE MESYLATE ESJAY PHARMA Manufacturing (CMC) Approval
02/27/2014 MONISTAT 3
NDA #018888		 SUPPL-18 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/27/2014 MEVACOR
NDA #019643		 SUPPL-88 LOVASTATIN MERCK Labeling Approval
02/27/2014 ZOCOR
NDA #019766		 SUPPL-91 SIMVASTATIN ORGANON Labeling Approval
02/27/2014 MIACALCIN
NDA #020313		 SUPPL-35 CALCITONIN SALMON SAPTALIS PHARMS Manufacturing (CMC) Approval
02/27/2014 CEREZYME
BLA #020367		 SUPPL-90 IMIGLUCERASE GENZYME Approval
02/27/2014 MONISTAT 3
NDA #020827		 SUPPL-24 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/27/2014 ANDROGEL
NDA #021015		 SUPPL-37 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
02/27/2014 MONISTAT 3 COMBINATION PACK
NDA #021261		 SUPPL-17 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/27/2014 MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261		 SUPPL-17 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
02/27/2014 VYTORIN
NDA #021687		 SUPPL-50 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
02/27/2014 ELESTRIN
NDA #021813		 SUPPL-4 ESTRADIOL VIATRIS Manufacturing (CMC) Approval
02/27/2014 BROVANA
NDA #021912		 SUPPL-23 ARFORMOTEROL TARTRATE LUPIN Efficacy Approval
02/27/2014 SYMBICORT
NDA #021929		 SUPPL-36 BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE ASTRAZENECA Manufacturing (CMC) Approval
02/27/2014 AXIRON
NDA #022504		 SUPPL-9 TESTOSTERONE ELI LILLY AND CO Manufacturing (CMC) Approval
02/27/2014 TACROLIMUS
ANDA #065461		 SUPPL-23 TACROLIMUS SANDOZ Labeling Approval
02/27/2014 DILANTIN
ANDA #084349		 SUPPL-62 PHENYTOIN SODIUM VIATRIS Labeling Approval
02/27/2014 DILANTIN
ANDA #084349		 SUPPL-72 PHENYTOIN SODIUM VIATRIS Labeling Approval
02/27/2014 DILANTIN
ANDA #084427		 SUPPL-17 PHENYTOIN PHARMACIA Labeling Approval
02/27/2014 DILANTIN
ANDA #084427		 SUPPL-22 PHENYTOIN PHARMACIA Labeling Approval
02/27/2014 DILANTIN
ANDA #084427		 SUPPL-25 PHENYTOIN PHARMACIA Labeling Approval
02/27/2014 DILANTIN
ANDA #084427		 SUPPL-30 PHENYTOIN PHARMACIA Labeling Approval
02/27/2014 LUCENTIS
BLA #125156		 SUPPL-94 RANIBIZUMAB GENENTECH Approval
02/28/2014 PHOSPHOLINE IODIDE
NDA #011963		 SUPPL-47 ECHOTHIOPHATE IODIDE FERA PHARMS LLC Manufacturing (CMC) Approval
02/28/2014 PREGNYL
BLA #017692		 SUPPL-24 GONADOTROPIN, CHORIONIC ORGANON USA LLC Approval
02/28/2014 DDAVP
NDA #017922		 SUPPL-43 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
02/28/2014 DDAVP (NEEDS NO REFRIGERATION)
NDA #017922		 SUPPL-43 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
02/28/2014 MPI DMSA KIDNEY REAGENT
NDA #017944		 SUPPL-24 TECHNETIUM TC-99M SUCCIMER KIT GE HEALTHCARE Manufacturing (CMC) Approval
02/28/2014 LIDEX
NDA #018849		 SUPPL-20 FLUOCINONIDE ALVOGEN Manufacturing (CMC) Approval
02/28/2014 DDAVP
NDA #019955		 SUPPL-16 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
02/28/2014 VOLTAREN-XR
NDA #020254		 SUPPL-25 DICLOFENAC SODIUM NOVARTIS Manufacturing (CMC) Approval
02/28/2014 HYCAMTIN
NDA #020671		 SUPPL-20 TOPOTECAN HYDROCHLORIDE SANDOZ Labeling Approval
02/28/2014 INOMAX
NDA #020845		 SUPPL-15 NITRIC OXIDE MALLINCKRODT IRELAND Manufacturing (CMC) Approval
02/28/2014 TRILEPTAL
NDA #021285		 SUPPL-28 OXCARBAZEPINE NOVARTIS Manufacturing (CMC) Approval
02/28/2014 MEN'S ROGAINE
NDA #021812		 SUPPL-9 MINOXIDIL KENVUE BRANDS Efficacy Approval
02/28/2014 WOMEN'S ROGAINE
NDA #021812		 SUPPL-9 MINOXIDIL KENVUE BRANDS Efficacy Approval
02/28/2014 FLO-PRED
NDA #022067		 SUPPL-10 PREDNISOLONE ACETATE SUN PHARMA CANADA Manufacturing (CMC) Approval
02/28/2014 BYDUREON
NDA #022200		 SUPPL-7 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
02/28/2014 BYDUREON
NDA #022200		 SUPPL-8 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
02/28/2014 BYDUREON PEN
NDA #022200		 SUPPL-7 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
02/28/2014 BYDUREON PEN
NDA #022200		 SUPPL-8 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
02/28/2014 SAMSCA
NDA #022275		 SUPPL-14 TOLVAPTAN OTSUKA Labeling Approval
02/28/2014 ANDROGEL
NDA #022309		 SUPPL-10 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
02/28/2014 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-2 TOPOTECAN HYDROCHLORIDE MEITHEAL Labeling Approval
02/28/2014 ACANYA
NDA #050819		 SUPPL-10 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Labeling Approval
02/28/2014 ONEXTON
NDA #050819		 SUPPL-10 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Labeling Approval
02/28/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-18 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
02/28/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075872		 SUPPL-15 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
02/28/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075872		 SUPPL-16 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
02/28/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076007		 SUPPL-16 HYDROCHLOROTHIAZIDE; LISINOPRIL SUN PHARM INDS LTD Labeling Approval
02/28/2014 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #077117		 SUPPL-2 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE APOTEX INC Labeling Approval
02/28/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077912		 SUPPL-19 HYDROCHLOROTHIAZIDE; LISINOPRIL LUPIN Labeling Approval
02/28/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077912		 SUPPL-20 HYDROCHLOROTHIAZIDE; LISINOPRIL LUPIN Labeling Approval
02/28/2014 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077912		 SUPPL-23 HYDROCHLOROTHIAZIDE; LISINOPRIL LUPIN Labeling Approval
02/28/2014 ALBUTEROL SULFATE
ANDA #078623		 SUPPL-1 ALBUTEROL SULFATE APOTEX INC Labeling Approval
02/28/2014 TOPOTECAN
NDA #200199		 SUPPL-3 TOPOTECAN HYDROCHLORIDE SANDOZ INC Labeling Approval
02/28/2014 TEFLARO
NDA #200327		 SUPPL-12 CEFTAROLINE FOSAMIL ABBVIE Manufacturing (CMC) Approval
02/28/2014 TOPOTECAN HYDROCHLORIDE
NDA #200582		 SUPPL-1 TOPOTECAN HYDROCHLORIDE HOSPIRA INC Labeling Approval
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NDA #200603		 SUPPL-17 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Manufacturing (CMC) Approval
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ANDA #202328		 SUPPL-5 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
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NDA #203756		 SUPPL-1 CABOZANTINIB S-MALATE EXELIXIS Manufacturing (CMC) Approval
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