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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 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 10, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/03/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #091272		 SUPPL-7 VENLAFAXINE HYDROCHLORIDE SUN PHARM Labeling Approval
03/04/2014 AZULFIDINE
NDA #007073		 SUPPL-128 SULFASALAZINE PFIZER Labeling Approval
03/04/2014 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-128 SULFASALAZINE PFIZER Labeling Approval
03/04/2014 HUMULIN N
BLA #018781		 SUPPL-139 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/04/2014 HUMULIN 70/30
BLA #019717		 SUPPL-118 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/04/2014 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-118 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/04/2014 ADAGEN
BLA #019818		 SUPPL-52 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
03/04/2014 HUMALOG
BLA #020563		 SUPPL-144 INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-144 INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 HUMALOG PEN
BLA #020563		 SUPPL-144 INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-144 INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 CRINONE
NDA #020701		 SUPPL-27 PROGESTERONE ABBVIE Manufacturing (CMC) Approval
03/04/2014 NOVOLOG
BLA #020986		 SUPPL-74 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-74 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-74 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 NOVOLOG INNOLET
BLA #020986		 SUPPL-74 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 NOVOLOG PENFILL
BLA #020986		 SUPPL-74 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 PROTONIX IV
NDA #020988		 SUPPL-47 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
03/04/2014 HUMALOG MIX 75/25
BLA #021017		 SUPPL-97 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-97 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-97 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/04/2014 COPEGUS
NDA #021511		 SUPPL-27 RIBAVIRIN ROCHE Manufacturing (CMC) Approval
03/04/2014 LEVEMIR
BLA #021536		 SUPPL-46 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-46 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-46 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 LEVEMIR INNOLET
BLA #021536		 SUPPL-46 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 LEVEMIR PENFILL
BLA #021536		 SUPPL-46 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
03/04/2014 NEXIUM IV
NDA #021689		 SUPPL-14 ESOMEPRAZOLE SODIUM ASTRAZENECA Efficacy Approval
03/04/2014 DUEXIS
NDA #022519		 SUPPL-8 FAMOTIDINE; IBUPROFEN HORIZON Manufacturing (CMC) Approval
03/04/2014 CLOPIDOGREL BISULFATE
ANDA #076274		 ORIG-2 CLOPIDOGREL BISULFATE APOTEX INC Approval
03/04/2014 MOXIFLOXACIN HYDROCHLORIDE
ANDA #076938		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE DR REDDYS Approval
03/04/2014 LEVOFLOXACIN
ANDA #077438		 SUPPL-1 LEVOFLOXACIN SANDOZ Manufacturing (CMC) Approval
03/04/2014 LEVOFLOXACIN
ANDA #077438		 SUPPL-2 LEVOFLOXACIN SANDOZ Manufacturing (CMC) Approval
03/04/2014 RALOXIFENE HYDROCHLORIDE
ANDA #078193		 ORIG-1 RALOXIFENE HYDROCHLORIDE TEVA PHARMS USA Approval
03/04/2014 OXYBUTYNIN
ANDA #090526		 ORIG-1 OXYBUTYNIN BARR LABS DIV TEVA Approval
03/04/2014 ZOLMITRIPTAN
ANDA #090861		 ORIG-1 ZOLMITRIPTAN ANI PHARMS Approval
03/04/2014 STELARA
BLA #125261		 SUPPL-114 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
03/04/2014 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #202588		 ORIG-1 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE SANDOZ Approval
03/04/2014 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/04/2014 HELIUM, USP
NDA #206826		 ORIG-1 HELIUM LINDE GAS NORTH AMERICA LLC Medical Gas Approval
03/05/2014 COLAZAL
NDA #020610		 SUPPL-19 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Manufacturing (CMC) Approval
03/05/2014 GLUCOPHAGE XR
NDA #021202		 SUPPL-20 METFORMIN HYDROCHLORIDE EMD SERONO INC Manufacturing (CMC) Approval
03/05/2014 FORTEO
NDA #021318		 SUPPL-37 TERIPARATIDE LILLY Manufacturing (CMC) Approval
03/05/2014 MIRALAX
NDA #022015		 SUPPL-19 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
03/05/2014 AVEED
NDA #022219		 ORIG-1 TESTOSTERONE UNDECANOATE ENDO OPERATIONS Type 3 - New Dosage Form Approval
03/05/2014 CIPROFLOXACIN
ANDA #200563		 ORIG-1 CIPROFLOXACIN CHARTWELL Approval
03/05/2014 DOXYCYCLINE
ANDA #204234		 ORIG-1 DOXYCYCLINE LUPIN Approval
03/06/2014 ALDACTAZIDE
NDA #012616		 SUPPL-75 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER Labeling Approval
03/06/2014 TYLENOL
NDA #019872		 SUPPL-40 ACETAMINOPHEN KENVUE BRANDS Labeling Approval
03/06/2014 REVATIO
NDA #021845		 SUPPL-14 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/06/2014 XARELTO
NDA #022406		 SUPPL-9 RIVAROXABAN JANSSEN PHARMS Labeling Approval
03/06/2014 REVATIO
NDA #022473		 SUPPL-7 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/06/2014 ACYCLOVIR
ANDA #201445		 ORIG-1 ACYCLOVIR CADILA PHARMS LTD Approval
03/06/2014 SPIRONOLACTONE
ANDA #202187		 ORIG-1 SPIRONOLACTONE AUROBINDO PHARMA Approval
03/06/2014 REVATIO
NDA #203109		 SUPPL-5 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/06/2014 NALOXONE HYDROCHLORIDE
ANDA #204997		 ORIG-1 NALOXONE HYDROCHLORIDE MYLAN INSTITUTIONAL Approval
03/07/2014 KEPPRA
NDA #021035		 SUPPL-91 LEVETIRACETAM UCB INC Labeling Approval
03/07/2014 NITROSTAT
NDA #021134		 SUPPL-7 NITROGLYCERIN VIATRIS Labeling Approval
03/07/2014 MIRENA
NDA #021225		 SUPPL-29 LEVONORGESTREL BAYER HLTHCARE Manufacturing (CMC) Approval
03/07/2014 CLARINEX-D 12 HOUR
NDA #021313		 SUPPL-5 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON LLC Labeling Approval
03/07/2014 KEPPRA
NDA #021505		 SUPPL-31 LEVETIRACETAM UCB INC Labeling Approval
03/07/2014 CLARINEX D 24 HOUR
NDA #021605		 SUPPL-12 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON Labeling Approval
03/07/2014 NEVANAC
NDA #021862		 SUPPL-10 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
03/07/2014 KEPPRA
NDA #021872		 SUPPL-15 LEVETIRACETAM UCB INC Labeling Approval
03/07/2014 STAVZOR
NDA #022152		 SUPPL-6 VALPROIC ACID BIONPHARMA Labeling Approval
03/07/2014 KEPPRA XR
NDA #022285		 SUPPL-16 LEVETIRACETAM UCB INC Labeling Approval
03/07/2014 KEPPRA XR
NDA #022285		 SUPPL-19 LEVETIRACETAM UCB INC Labeling Approval
03/07/2014 BRILINTA
NDA #022433		 SUPPL-11 TICAGRELOR ASTRAZENECA Manufacturing (CMC) Approval
03/07/2014 PANCREAZE
BLA #022523		 SUPPL-4 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC Approval
03/07/2014 GENTAMICIN SULFATE
ANDA #062366		 SUPPL-33 GENTAMICIN SULFATE FRESENIUS KABI USA Labeling Approval
03/07/2014 ZAFIRLUKAST
ANDA #090372		 SUPPL-2 ZAFIRLUKAST DR REDDYS LABS LTD Labeling Approval
03/07/2014 DEXTROAMPHETAMINE SULFATE
ANDA #090652		 ORIG-1 DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Approval
03/07/2014 HERCEPTIN
BLA #103792		 SUPPL-5311 TRASTUZUMAB GENENTECH Approval
03/07/2014 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #202150		 ORIG-1 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE HERITAGE Approval
03/07/2014 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 ORIG-1 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Approval
03/10/2014 MONISTAT 7
NDA #017450		 SUPPL-67 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
03/10/2014 MONISTAT 3
NDA #020827		 SUPPL-25 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
03/10/2014 ARGATROBAN
NDA #020883		 SUPPL-16 ARGATROBAN SANDOZ Labeling Approval
03/10/2014 MONISTAT 3 COMBINATION PACK
NDA #021261		 SUPPL-18 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
03/10/2014 MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261		 SUPPL-18 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
03/10/2014 SYNERA
NDA #021623		 SUPPL-15 LIDOCAINE; TETRACAINE GALEN SPECIALTY Labeling Approval
03/10/2014 SYNERA
NDA #021623		 SUPPL-17 LIDOCAINE; TETRACAINE GALEN SPECIALTY Labeling Approval
03/10/2014 ORABLOC
NDA #022466		 SUPPL-2 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE PIERREL Manufacturing (CMC) Approval
03/10/2014 EPITOL
ANDA #070541		 SUPPL-54 CARBAMAZEPINE TEVA Labeling Approval
03/10/2014 EPITOL
ANDA #070541		 SUPPL-55 CARBAMAZEPINE TEVA Labeling Approval
03/10/2014 EPITOL
ANDA #073524		 SUPPL-38 CARBAMAZEPINE TEVA Labeling Approval
03/10/2014 EPITOL
ANDA #073524		 SUPPL-39 CARBAMAZEPINE TEVA Labeling Approval
03/10/2014 RISPERIDONE
ANDA #078036		 ORIG-1 RISPERIDONE SUN PHARM INDS INC Approval
03/10/2014 CROTAN
ANDA #087204		 SUPPL-6 CROTAMITON LEGACY Labeling Approval
03/10/2014 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091155		 ORIG-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TEVA PHARMS USA Approval
03/10/2014 QUININE SULFATE
ANDA #091661		 SUPPL-2 QUININE SULFATE TEVA PHARMS Labeling Approval
03/10/2014 CARBIDOPA
ANDA #203261		 ORIG-1 CARBIDOPA ANI PHARMS Approval
03/11/2014 DANTRIUM
NDA #017443		 SUPPL-64 DANTROLENE SODIUM PH HEALTH Manufacturing (CMC) Approval
03/11/2014 MIACALCIN
NDA #017808		 SUPPL-35 CALCITONIN SALMON MYLAN IRELAND LTD Labeling Approval
03/11/2014 MOTRIN IB
NDA #019012		 SUPPL-52 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/11/2014 MOTRIN MIGRAINE PAIN
NDA #019012		 SUPPL-52 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/11/2014 NUPRIN
NDA #019012		 SUPPL-52 IBUPROFEN KENVUE BRANDS Manufacturing (CMC) Approval
03/11/2014 PROSCAR
NDA #020180		 SUPPL-44 FINASTERIDE ORGANON Labeling Approval
03/11/2014 MIACALCIN
NDA #020313		 SUPPL-34 CALCITONIN SALMON SAPTALIS PHARMS Labeling Approval
03/11/2014 ULTANE
NDA #020478		 SUPPL-25 SEVOFLURANE ABBVIE Labeling Approval
03/11/2014 ULTANE
NDA #020478		 SUPPL-26 SEVOFLURANE ABBVIE Labeling Approval
03/11/2014 INFASURF PRESERVATIVE FREE
BLA #020521		 SUPPL-27 CALFACTANT ONY Approval
03/11/2014 INFANT'S ADVIL
NDA #020812		 SUPPL-21 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
03/11/2014 PEDIATRIC ADVIL
NDA #020812		 SUPPL-21 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
03/11/2014 VIAGRA
NDA #020895		 SUPPL-39 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/11/2014 VIAGRA
NDA #020895		 SUPPL-42 SILDENAFIL CITRATE VIATRIS Efficacy Approval
03/11/2014 REVATIO
NDA #021845		 SUPPL-11 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/11/2014 EVAMIST
NDA #022014		 SUPPL-6 ESTRADIOL PADAGIS US Labeling Approval
03/11/2014 AKTEN
NDA #022221		 SUPPL-5 LIDOCAINE HYDROCHLORIDE THEA PHARMA Labeling Approval
03/11/2014 WELCHOL
NDA #022362		 SUPPL-19 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
03/11/2014 REVATIO
NDA #022473		 SUPPL-4 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/11/2014 CEFAZOLIN AND DEXTROSE
NDA #050779		 SUPPL-21 CEFAZOLIN SODIUM B BRAUN Manufacturing (CMC) Approval
03/11/2014 ZALEPLON
ANDA #077237		 SUPPL-1 ZALEPLON HIKMA PHARMS Labeling Approval
03/11/2014 ZALEPLON
ANDA #078829		 SUPPL-6 ZALEPLON AUROBINDO PHARMA Labeling Approval
03/11/2014 ZALEPLON
ANDA #090374		 SUPPL-1 ZALEPLON ORBION PHARMS Labeling Approval
03/11/2014 ACAMPROSATE CALCIUM
ANDA #200142		 ORIG-1 ACAMPROSATE CALCIUM MYLAN Approval
03/11/2014 LEVONORGESTREL
ANDA #200670		 SUPPL-6 LEVONORGESTREL FDN CONSUMER Labeling Approval
03/11/2014 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #202277		 ORIG-1 CETIRIZINE HYDROCHLORIDE AIPING PHARM INC Approval
03/11/2014 CETIRIZINE HYDROCHLORIDE HIVES
ANDA #202277		 ORIG-1 CETIRIZINE HYDROCHLORIDE AIPING PHARM INC Approval
03/11/2014 REVATIO
NDA #203109		 SUPPL-2 SILDENAFIL CITRATE VIATRIS Labeling Approval
03/11/2014 ZOLEDRONIC ACID
NDA #203231		 SUPPL-4 ZOLEDRONIC ACID INFORLIFE Manufacturing (CMC) Approval
03/11/2014 XARTEMIS XR
NDA #204031		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MALLINCKRODT INC Type 3 - New Dosage Form Approval
03/11/2014 QUDEXY XR
NDA #205122		 ORIG-1 TOPIRAMATE UPSHER SMITH LABS Type 3 - New Dosage Form Approval
03/12/2014 FREAMINE 8.5%
NDA #016822		 SUPPL-72 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE HBC 6.9%
NDA #016822		 SUPPL-72 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE II 8.5%
NDA #016822		 SUPPL-72 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE III 10%
NDA #016822		 SUPPL-72 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE III 3% W/ ELECTROLYTES
NDA #016822		 SUPPL-72 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE III 8.5%
NDA #016822		 SUPPL-72 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
03/12/2014 FREAMINE III 8.5% W/ ELECTROLYTES
NDA #016822		 SUPPL-72 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE B BRAUN Manufacturing (CMC) Approval
03/12/2014 EDEX
NDA #020649		 SUPPL-22 ALPROSTADIL ENDO OPERATIONS Manufacturing (CMC) Approval
03/12/2014 ZOMIG
NDA #020768		 SUPPL-22 ZOLMITRIPTAN IPR Manufacturing (CMC) Approval
03/12/2014 PLAVIX
NDA #020839		 SUPPL-59 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/12/2014 ATROPINE SULFATE
NDA #021146		 SUPPL-14 ATROPINE SULFATE HOSPIRA Manufacturing (CMC) Approval
03/12/2014 XIFAXAN
NDA #021361		 SUPPL-13 RIFAXIMIN SALIX PHARMS Labeling Approval
03/12/2014 ALPHAGAN P
NDA #021770		 SUPPL-8 BRIMONIDINE TARTRATE ABBVIE Manufacturing (CMC) Approval
03/12/2014 SUBOXONE
NDA #022410		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
03/12/2014 ZYMAXID
NDA #022548		 SUPPL-1 GATIFLOXACIN ABBVIE Manufacturing (CMC) Approval
03/12/2014 ZALEPLON
ANDA #078989		 SUPPL-3 ZALEPLON UNICHEM Labeling Approval
03/12/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091159		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE MOUNTAIN Approval
03/12/2014 PICATO
NDA #202833		 SUPPL-2 INGENOL MEBUTATE LEO LABS Labeling Approval
03/12/2014 LIDOCAINE HYDROCHLORIDE
ANDA #204494		 ORIG-1 LIDOCAINE HYDROCHLORIDE PAI HOLDINGS PHARM Approval
03/13/2014 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-54 HEPARIN SODIUM HOSPIRA Labeling Approval
03/13/2014 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-54 HEPARIN SODIUM HOSPIRA Labeling Approval
03/13/2014 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-54 HEPARIN SODIUM HOSPIRA Labeling Approval
03/13/2014 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-36 HEPARIN SODIUM HOSPIRA Labeling Approval
03/13/2014 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-36 HEPARIN SODIUM HOSPIRA Labeling Approval
03/13/2014 ASTELIN
NDA #020114		 SUPPL-25 AZELASTINE HYDROCHLORIDE RISING Manufacturing (CMC) Approval
03/13/2014 VELCADE
NDA #021602		 SUPPL-37 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/13/2014 TACLONEX
NDA #021852		 SUPPL-14 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
03/13/2014 VIBATIV
NDA #022110		 SUPPL-9 TELAVANCIN HYDROCHLORIDE APOTEX Manufacturing (CMC) Approval
03/13/2014 ASTEPRO
NDA #022203		 SUPPL-9 AZELASTINE HYDROCHLORIDE VIATRIS Manufacturing (CMC) Approval
03/13/2014 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040440		 SUPPL-5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
03/13/2014 CHLORZOXAZONE
ANDA #040861		 SUPPL-2 CHLORZOXAZONE PHARMOBEDIENT Labeling Approval
03/13/2014 CLOPIDOGREL BISULFATE
ANDA #076274		 SUPPL-4 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
03/13/2014 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #077107		 SUPPL-9 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS Labeling Approval
03/13/2014 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #077107		 SUPPL-10 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS Labeling Approval
03/13/2014 ELIQUIS
NDA #202155		 SUPPL-3 APIXABAN BRISTOL MYERS SQUIBB Efficacy Approval
03/13/2014 DOCETAXEL
NDA #202356		 ORIG-1 DOCETAXEL PFIZER LABS Type 5 - New Formulation or New Manufacturer Approval
03/13/2014 MYRBETRIQ
NDA #202611		 SUPPL-3 MIRABEGRON APGDI Manufacturing (CMC) Approval
03/13/2014 CLINDAMYCIN PALMITATE HYDROCHLORIDE
ANDA #203513		 ORIG-1 CLINDAMYCIN PALMITATE HYDROCHLORIDE AMNEAL PHARMS Approval
03/13/2014 POMALYST
NDA #204026		 SUPPL-3 POMALIDOMIDE BRISTOL Labeling Approval
03/13/2014 SODIUM FLUORIDE F-18
ANDA #204437		 ORIG-1 SODIUM FLUORIDE F-18 UCSF RODIOPHARM Approval
03/13/2014 NOXAFIL
NDA #205596		 ORIG-1 POSACONAZOLE MERCK SHARP DOHME Type 3 - New Dosage Form Approval
03/14/2014 NAVELBINE
NDA #020388		 SUPPL-27 VINORELBINE TARTRATE PIERRE FABRE Labeling Approval
03/14/2014 TRELSTAR
NDA #020715		 SUPPL-31 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
03/14/2014 GLUCAGEN
NDA #020918		 SUPPL-42 GLUCAGON HYDROCHLORIDE NOVO NORDISK Labeling Approval
03/14/2014 LIALDA
NDA #022000		 SUPPL-12 MESALAMINE TAKEDA PHARMS USA Labeling Approval
03/14/2014 SUMATRIPTAN SUCCINATE (AUTOINJECTOR)
ANDA #090358		 SUPPL-1 SUMATRIPTAN SUCCINATE SUN PHARM Labeling Approval
03/14/2014 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200540		 ORIG-1 DICLOFENAC SODIUM; MISOPROSTOL EXELA HOLDINGS Approval
03/14/2014 JEVTANA KIT
NDA #201023		 SUPPL-10 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
03/14/2014 JEVTANA KIT
NDA #201023		 SUPPL-12 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
03/14/2014 AMYVID
NDA #202008		 SUPPL-21 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
03/14/2014 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
NDA #205355		 ORIG-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE HETERO LABS LTD III Type 4 - New Combination Tentative Approval
03/14/2014 HEMANGEOL
NDA #205410		 ORIG-1 PROPRANOLOL HYDROCHLORIDE ETON Type 5 - New Formulation or New Manufacturer Approval
03/17/2014 MESNEX
NDA #019884		 SUPPL-13 MESNA BAXTER HLTHCARE Labeling Approval
03/17/2014 DIOVAN
NDA #020665		 SUPPL-34 VALSARTAN NOVARTIS Labeling Approval
03/17/2014 DIOVAN
NDA #020665		 SUPPL-35 VALSARTAN NOVARTIS Labeling Approval
03/17/2014 CREON
BLA #020725		 SUPPL-9 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
03/17/2014 DIOVAN HCT
NDA #020818		 SUPPL-58 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 DIOVAN HCT
NDA #020818		 SUPPL-62 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 MESNEX
NDA #020855		 SUPPL-2 MESNA BAXTER HLTHCARE Labeling Approval
03/17/2014 DIOVAN
NDA #021283		 SUPPL-41 VALSARTAN NOVARTIS Labeling Approval
03/17/2014 DIOVAN
NDA #021283		 SUPPL-42 VALSARTAN NOVARTIS Labeling Approval
03/17/2014 MEGACE ES
NDA #021778		 SUPPL-15 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
03/17/2014 EXFORGE
NDA #021990		 SUPPL-20 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 EXFORGE
NDA #021990		 SUPPL-21 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 EXFORGE HCT
NDA #022314		 SUPPL-15 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 EXFORGE HCT
NDA #022314		 SUPPL-16 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
03/17/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #078458		 SUPPL-8 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
03/17/2014 ATAZANAVIR SULFATE; RITONAVIR
NDA #205508		 ORIG-1 ATAZANAVIR SULFATE; RITONAVIR EMCURE PHARMS LTD Type 4 - New Combination Tentative Approval
03/18/2014 ROBINUL
NDA #017558		 SUPPL-60 GLYCOPYRROLATE HIKMA PHARMS Manufacturing (CMC) Approval
03/18/2014 HUMULIN R
BLA #018780		 SUPPL-146 INSULIN HUMAN LILLY Approval
03/18/2014 HUMULIN R
BLA #018780		 SUPPL-146 INSULIN RECOMBINANT HUMAN LILLY Approval
03/18/2014 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-146 INSULIN HUMAN LILLY Approval
03/18/2014 HUMULIN R PEN
BLA #018780		 SUPPL-146 INSULIN RECOMBINANT HUMAN LILLY Approval
03/18/2014 HUMULIN N
BLA #018781		 SUPPL-140 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/18/2014 HUMULIN 70/30
BLA #019717		 SUPPL-119 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/18/2014 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-119 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
03/18/2014 HUMALOG
BLA #020563		 SUPPL-145 INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-145 INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG PEN
BLA #020563		 SUPPL-145 INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-145 INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 75/25
BLA #021017		 SUPPL-98 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-98 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-98 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 50/50
BLA #021018		 SUPPL-90 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-90 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-90 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
03/18/2014 TEKTURNA
NDA #021985		 SUPPL-26 ALISKIREN HEMIFUMARATE LXO IRELAND Labeling Approval
03/18/2014 JANUMET
NDA #022044		 SUPPL-30 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
03/18/2014 TEKTURNA HCT
NDA #022107		 SUPPL-24 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE NODEN PHARMA Labeling Approval
03/18/2014 TEKAMLO
NDA #022545		 SUPPL-15 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE NOVARTIS Labeling Approval
03/18/2014 ACANYA
NDA #050819		 SUPPL-11 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
03/18/2014 ONEXTON
NDA #050819		 SUPPL-11 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
03/18/2014 MIRTAZAPINE
ANDA #076122		 SUPPL-17 MIRTAZAPINE MYLAN Labeling Approval
03/18/2014 DIVALPROEX SODIUM
ANDA #078853		 SUPPL-5 DIVALPROEX SODIUM ORBION PHARMS Labeling Approval
03/18/2014 DIVALPROEX SODIUM
ANDA #078853		 SUPPL-6 DIVALPROEX SODIUM ORBION PHARMS Labeling Approval
03/18/2014 DIVALPROEX SODIUM
ANDA #078853		 SUPPL-7 DIVALPROEX SODIUM ORBION PHARMS Labeling Approval
03/18/2014 CARBAMAZEPINE
ANDA #078986		 SUPPL-2 CARBAMAZEPINE APOTEX INC Labeling Approval
03/18/2014 IBUPROFEN
ANDA #079233		 ORIG-1 IBUPROFEN AMNEAL PHARMS Approval
03/18/2014 AMTURNIDE
NDA #200045		 SUPPL-15 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
03/18/2014 LEVETIRACETAM
ANDA #200475		 SUPPL-4 LEVETIRACETAM AUROBINDO PHARMA USA Labeling Approval
03/18/2014 ATOVAQUONE
ANDA #202960		 ORIG-1 ATOVAQUONE AMNEAL PHARMS Approval
03/19/2014 DIAMOX
NDA #012945		 SUPPL-45 ACETAZOLAMIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
03/19/2014 GALLIUM CITRATE GA 67
NDA #018058		 SUPPL-13 GALLIUM CITRATE GA-67 CURIUM Manufacturing (CMC) Approval
03/19/2014 PERFOROMIST
NDA #022007		 SUPPL-9 FORMOTEROL FUMARATE VIATRIS SPECIALTY Manufacturing (CMC) Approval
03/19/2014 MULTAQ
NDA #022425		 SUPPL-22 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US REMS Approval
03/19/2014 MULTAQ
NDA #022425		 SUPPL-24 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US REMS Approval
03/19/2014 MULTAQ
NDA #022425		 SUPPL-26 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
03/19/2014 PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
NDA #050638		 SUPPL-18 PENICILLIN G POTASSIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
03/19/2014 PROGRAF
NDA #050708		 SUPPL-44 TACROLIMUS ASTELLAS Manufacturing (CMC) Approval
03/19/2014 FONDAPARINUX SODIUM
ANDA #091316		 SUPPL-2 FONDAPARINUX SODIUM DR REDDYS LABS LTD Labeling Approval
03/19/2014 SODIUM POLYSTYRENE SULFONATE
ANDA #202333		 ORIG-1 SODIUM POLYSTYRENE SULFONATE EPIC PHARMA LLC Approval
03/19/2014 ZELBORAF
NDA #202429		 SUPPL-4 VEMURAFENIB HOFFMANN LA ROCHE Efficacy Approval
03/19/2014 LEVONORGESTREL
ANDA #202508		 SUPPL-1 LEVONORGESTREL NOVEL LABS INC Labeling Approval
03/19/2014 LEVONORGESTREL
ANDA #202508		 SUPPL-3 LEVONORGESTREL NOVEL LABS INC Labeling Approval
03/19/2014 QNASL
NDA #202813		 SUPPL-5 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Labeling Approval
03/19/2014 SIRTURO
NDA #204384		 SUPPL-1 BEDAQUILINE FUMARATE JANSSEN THERAP Manufacturing (CMC) Approval
03/19/2014 NEURACEQ
NDA #204677		 ORIG-1 FLORBETABEN F-18 LANTHEUS Type 1 - New Molecular Entity Approval
03/19/2014 IMPAVIDO
NDA #204684		 ORIG-1 MILTEFOSINE KNIGHT THERAPS Type 1 - New Molecular Entity Approval
03/20/2014 SODIUM IODIDE I 131
NDA #016515		 SUPPL-12 SODIUM IODIDE I-131 CURIUM Labeling Approval
03/20/2014 SODIUM IODIDE I 131
NDA #016517		 SUPPL-11 SODIUM IODIDE I-131 CURIUM Labeling Approval
03/20/2014 SUFENTA PRESERVATIVE FREE
NDA #019050		 SUPPL-32 SUFENTANIL CITRATE RISING Labeling Approval
03/20/2014 FENTANYL CITRATE
NDA #019101		 SUPPL-39 FENTANYL CITRATE HIKMA PHARMS Manufacturing (CMC) Approval
03/20/2014 BREVIBLOC
NDA #019386		 SUPPL-46 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/20/2014 BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #019386		 SUPPL-46 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/20/2014 BREVIBLOC IN PLASTIC CONTAINER
NDA #019386		 SUPPL-46 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/20/2014 IMODIUM A-D EZ CHEWS
NDA #020448		 SUPPL-8 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
03/20/2014 PEPCID AC
NDA #020801		 SUPPL-18 FAMOTIDINE KENVUE BRANDS Manufacturing (CMC) Approval
03/20/2014 PEPCID COMPLETE
NDA #020958		 SUPPL-21 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE KENVUE BRANDS Manufacturing (CMC) Approval
03/20/2014 TEMODAR
NDA #021029		 SUPPL-24 TEMOZOLOMIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
03/20/2014 BARACLUDE
NDA #021797		 SUPPL-18 ENTECAVIR BRISTOL MYERS SQUIBB Efficacy Approval
03/20/2014 BARACLUDE
NDA #021798		 SUPPL-19 ENTECAVIR BRISTOL MYERS SQUIBB Efficacy Approval
03/20/2014 VIMOVO
NDA #022511		 SUPPL-11 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Manufacturing (CMC) Approval
03/20/2014 DIVALPROEX SODIUM
ANDA #078597		 SUPPL-7 DIVALPROEX SODIUM SUN PHARM INDS Labeling Approval
03/20/2014 DIVALPROEX SODIUM
ANDA #078597		 SUPPL-8 DIVALPROEX SODIUM SUN PHARM INDS Labeling Approval
03/20/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085868		 SUPPL-58 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
03/20/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087006		 SUPPL-28 ACETAMINOPHEN; CODEINE PHOSPHATE PHARMOBEDIENT Labeling Approval
03/20/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087083		 SUPPL-45 ACETAMINOPHEN; CODEINE PHOSPHATE SUN PHARM INDS LTD Labeling Approval
03/20/2014 NIACIN
ANDA #090446		 ORIG-1 NIACIN CHARTWELL RX Approval
03/20/2014 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-1 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/20/2014 NIACIN
ANDA #090860		 ORIG-1 NIACIN CHARTWELL RX Approval
03/20/2014 NIACIN
ANDA #090892		 ORIG-1 NIACIN CHARTWELL RX Approval
03/20/2014 INDOMETHACIN
ANDA #202139		 ORIG-1 INDOMETHACIN MYLAN Approval
03/20/2014 LARIN 1.5/30
ANDA #202996		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
03/20/2014 METFORMIN HYDROCHLORIDE
ANDA #203769		 SUPPL-1 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS Manufacturing (CMC) Approval
03/21/2014 LIPIODOL
NDA #009190		 SUPPL-21 ETHIODIZED OIL GUERBET Labeling Approval
03/21/2014 HEPARIN SODIUM
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-135 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 HEPARIN SODIUM
NDA #017651		 SUPPL-59 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
03/21/2014 TUSSIONEX PENNKINETIC
NDA #019111		 SUPPL-17 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX UCB INC Manufacturing (CMC) Approval
03/21/2014 THYROGEN
BLA #020898		 SUPPL-54 THYROTROPIN ALFA GENZYME Approval
03/21/2014 STRIANT
NDA #021543		 SUPPL-9 TESTOSTERONE AUXILIUM PHARMS LLC Labeling Approval
03/21/2014 ADENOSINE
ANDA #078640		 ORIG-1 ADENOSINE PHARMOBEDIENT Approval
03/21/2014 SYNAGIS
BLA #103770		 SUPPL-5185 PALIVIZUMAB SWEDISH ORPHAN Approval
03/21/2014 XOLAIR
BLA #103976		 SUPPL-5211 OMALIZUMAB GENENTECH Approval
03/21/2014 ZECUITY
NDA #202278		 SUPPL-1 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Labeling Approval
03/21/2014 ZECUITY
NDA #202278		 SUPPL-2 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Labeling Approval
03/21/2014 OTEZLA
NDA #205437		 ORIG-1 APREMILAST AMGEN INC Type 1 - New Molecular Entity Approval
03/22/2014 AUVI-Q
NDA #201739		 SUPPL-2 EPINEPHRINE KALEO INC Manufacturing (CMC) Approval
03/23/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075909		 SUPPL-4 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE SENORES PHARMS Manufacturing (CMC) Approval
03/24/2014 BETAMETHASONE VALERATE
NDA #018866		 SUPPL-13 BETAMETHASONE VALERATE FOUGERA Manufacturing (CMC) Approval
03/24/2014 DIFLUCAN
NDA #019949		 SUPPL-58 FLUCONAZOLE PFIZER Labeling Approval
03/24/2014 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-62 FLUCONAZOLE PFIZER Labeling Approval
03/24/2014 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-62 FLUCONAZOLE PFIZER Labeling Approval
03/24/2014 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-62 FLUCONAZOLE PFIZER Labeling Approval
03/24/2014 DIFLUCAN
NDA #020090		 SUPPL-42 FLUCONAZOLE PFIZER Labeling Approval
03/24/2014 ADRENACLICK
NDA #020800		 SUPPL-25 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
03/24/2014 TWINJECT
NDA #020800		 SUPPL-25 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
03/24/2014 FORTESTA
NDA #021463		 SUPPL-12 TESTOSTERONE ENDO OPERATIONS Labeling Approval
03/24/2014 PREVANTICS MAXI SWABSTICK
NDA #021524		 SUPPL-14 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
03/24/2014 PREVANTICS SWAB
NDA #021524		 SUPPL-14 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
03/24/2014 PREVANTICS SWABSTICK
NDA #021524		 SUPPL-14 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
03/24/2014 BYDUREON
NDA #022200		 SUPPL-9 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
03/24/2014 BYDUREON PEN
NDA #022200		 SUPPL-9 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
03/24/2014 AZATHIOPRINE SODIUM
ANDA #074419		 SUPPL-11 AZATHIOPRINE SODIUM HIKMA PHARMS Labeling Approval
03/24/2014 GLYBURIDE (MICRONIZED)
ANDA #074686		 SUPPL-25 GLYBURIDE TEVA Labeling Approval
03/24/2014 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076303		 SUPPL-16 FLUCONAZOLE HOSPIRA Labeling Approval
03/24/2014 FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #076304		 SUPPL-15 FLUCONAZOLE HOSPIRA Labeling Approval
03/24/2014 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #077066		 SUPPL-16 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE SANDOZ Labeling Approval
03/24/2014 ADENOSINE
ANDA #203883		 ORIG-1 ADENOSINE HOSPIRA Approval
03/24/2014 NUVESSA
NDA #205223		 ORIG-1 METRONIDAZOLE ALEMBIC THERAP Type 5 - New Formulation or New Manufacturer Approval
03/25/2014 ACEPHEN
NDA #018060		 SUPPL-66 ACETAMINOPHEN COSETTE Labeling Approval
03/25/2014 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-30 METRONIDAZOLE B BRAUN Manufacturing (CMC) Approval
03/25/2014 SYNAREL
NDA #019886		 SUPPL-31 NAFARELIN ACETATE PFIZER Manufacturing (CMC) Approval
03/25/2014 ADRENACLICK
NDA #020800		 SUPPL-26 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
03/25/2014 TWINJECT
NDA #020800		 SUPPL-26 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
03/25/2014 VIAGRA
NDA #020895		 SUPPL-41 SILDENAFIL CITRATE VIATRIS Manufacturing (CMC) Approval
03/25/2014 FEMHRT
NDA #021065		 SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
03/25/2014 ESTROGEL
NDA #021166		 SUPPL-10 ESTRADIOL ASCEND THERAPS US Labeling Approval
03/25/2014 EMTRIVA
NDA #021500		 SUPPL-25 EMTRICITABINE GILEAD Manufacturing (CMC) Approval
03/25/2014 FLUDARABINE PHOSPHATE
NDA #022137		 SUPPL-5 FLUDARABINE PHOSPHATE CAPLIN ONE LABS Manufacturing (CMC) Approval
03/25/2014 FLUDARABINE PHOSPHATE
NDA #022137		 SUPPL-6 FLUDARABINE PHOSPHATE CAPLIN ONE LABS Manufacturing (CMC) Approval
03/25/2014 FLUDARABINE PHOSPHATE
NDA #022137		 SUPPL-7 FLUDARABINE PHOSPHATE CAPLIN ONE LABS Manufacturing (CMC) Approval
03/25/2014 FIRMAGON
NDA #022201		 SUPPL-4 DEGARELIX ACETATE FERRING Manufacturing (CMC) Approval
03/25/2014 ZENPEP
BLA #022210		 SUPPL-16 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
03/25/2014 GABAPENTIN
ANDA #077662		 SUPPL-13 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
03/25/2014 NICOTINE POLACRILEX
ANDA #078546		 SUPPL-14 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
03/25/2014 NICOTINE POLACRILEX
ANDA #078547		 SUPPL-14 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
03/25/2014 INCIVEK
NDA #201917		 SUPPL-13 TELAPREVIR VERTEX PHARMS Manufacturing (CMC) Approval
03/25/2014 VERSACLOZ
NDA #203479		 SUPPL-4 CLOZAPINE DOUGLAS PHARMS Manufacturing (CMC) Approval
03/26/2014 ACEBUTOLOL HYDROCHLORIDE
ANDA #074288		 SUPPL-9 ACEBUTOLOL HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
03/26/2014 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-18 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
03/26/2014 ZALEPLON
ANDA #078706		 SUPPL-4 ZALEPLON UPSHER SMITH LABS Labeling Approval
03/26/2014 XELJANZ
NDA #203214		 SUPPL-5 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
03/27/2014 PRILOSEC
NDA #019810		 SUPPL-98 OMEPRAZOLE ASTRAZENECA Labeling Approval
03/27/2014 ZYBAN
NDA #020711		 SUPPL-39 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
03/27/2014 GLUCAGON
NDA #020928		 SUPPL-48 GLUCAGON LILLY Manufacturing (CMC) Approval
03/27/2014 NEXIUM
NDA #021153		 SUPPL-46 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/27/2014 NEXIUM IV
NDA #021689		 SUPPL-27 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
03/27/2014 NEXIUM
NDA #021957		 SUPPL-15 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/27/2014 PRILOSEC
NDA #022056		 SUPPL-14 OMEPRAZOLE MAGNESIUM AZURITY Labeling Approval
03/27/2014 NEXIUM
NDA #022101		 SUPPL-12 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
03/27/2014 SELZENTRY
NDA #022128		 SUPPL-12 MARAVIROC VIIV HLTHCARE Labeling Approval
03/27/2014 TREANDA
NDA #022249		 SUPPL-17 BENDAMUSTINE HYDROCHLORIDE CEPHALON Manufacturing (CMC) Approval
03/27/2014 VIMOVO
NDA #022511		 SUPPL-10 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
03/27/2014 NICOTINE POLACRILEX
ANDA #076777		 SUPPL-28 NICOTINE POLACRILEX L PERRIGO CO Labeling Approval
03/27/2014 NICOTINE POLACRILEX
ANDA #076779		 SUPPL-27 NICOTINE POLACRILEX L PERRIGO CO Labeling Approval
03/27/2014 PARICALCITOL
ANDA #202539		 ORIG-1 PARICALCITOL BIONPHARMA Approval
03/27/2014 ICLUSIG
NDA #203469		 SUPPL-6 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
03/28/2014 SOLU-CORTEF
NDA #009866		 SUPPL-99 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
03/28/2014 SOLU-MEDROL
NDA #011856		 SUPPL-119 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
03/28/2014 DRAXIMAGE DTPA
NDA #018511		 SUPPL-24 TECHNETIUM TC-99M PENTETATE KIT JUBILANT Manufacturing (CMC) Approval
03/28/2014 SPECTAZOLE
NDA #018751		 SUPPL-23 ECONAZOLE NITRATE ALVOGEN Labeling Approval
03/28/2014 CAVERJECT
NDA #020379		 SUPPL-26 ALPROSTADIL PFIZER Manufacturing (CMC) Approval
03/28/2014 TOPAMAX
NDA #020505		 SUPPL-52 TOPIRAMATE JANSSEN PHARMS Efficacy Approval
03/28/2014 TOPAMAX
NDA #020844		 SUPPL-43 TOPIRAMATE JANSSEN PHARMS Efficacy Approval
03/28/2014 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-43 TOPIRAMATE JANSSEN PHARMS Efficacy Approval
03/28/2014 GEODON
NDA #020919		 SUPPL-36 ZIPRASIDONE MESYLATE VIATRIS Manufacturing (CMC) Approval
03/28/2014 ELIDEL
NDA #021302		 SUPPL-18 PIMECROLIMUS BAUSCH Labeling Approval
03/28/2014 ERAXIS
NDA #021632		 SUPPL-19 ANIDULAFUNGIN VICURON HOLDINGS Manufacturing (CMC) Approval
03/28/2014 DICLEGIS
NDA #021876		 SUPPL-3 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
03/28/2014 EXPAREL
NDA #022496		 SUPPL-6 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
03/28/2014 AUGMENTIN '875'
NDA #050720		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Manufacturing (CMC) Approval
03/28/2014 ACEBUTOLOL HYDROCHLORIDE
ANDA #074288		 SUPPL-10 ACEBUTOLOL HYDROCHLORIDE PHARMOBEDIENT Manufacturing (CMC) Approval
03/28/2014 ADENOSINE
ANDA #090212		 ORIG-1 ADENOSINE MYLAN ASI Approval
03/28/2014 KALBITOR
BLA #125277		 SUPPL-70 ECALLANTIDE DYAX CORP. Approval
03/28/2014 AMMONIA N 13
ANDA #204496		 ORIG-1 AMMONIA N-13 UCSF RODIOPHARM Approval
03/28/2014 NEXIUM 24HR
NDA #204655		 ORIG-1 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Type 8 - Partial Rx to OTC Switch Approval
03/29/2014 LEXISCAN
NDA #022161		 SUPPL-5 REGADENOSON ASTELLAS Manufacturing (CMC) Approval
03/29/2014 DEXTROAMPHETAMINE SULFATE
ANDA #040361		 SUPPL-17 DEXTROAMPHETAMINE SULFATE BARR Labeling Approval
03/31/2014 XOPENEX
NDA #020837		 SUPPL-39 LEVALBUTEROL HYDROCHLORIDE HIKMA PHARMS Labeling Approval
03/31/2014 TRI-LUMA
NDA #021112		 SUPPL-9 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN GALDERMA LABS LP Labeling Approval
03/31/2014 CHILDREN'S ELIXSURE
NDA #021604		 SUPPL-4 IBUPROFEN MOBERG PHARMA NORTH Labeling Approval
03/31/2014 CAPRELSA
NDA #022405		 SUPPL-7 VANDETANIB GENZYME CORP Labeling Approval
03/31/2014 MULTAQ
NDA #022425		 SUPPL-25 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
03/31/2014 ZOLPIDEM TARTRATE
ANDA #076578		 SUPPL-11 ZOLPIDEM TARTRATE RISING Labeling Approval
03/31/2014 ZOLEDRONIC ACID
ANDA #091170		 SUPPL-1 ZOLEDRONIC ACID BRECKENRIDGE Labeling Approval
03/31/2014 TRAMADOL HYDROCHLORIDE
ANDA #203494		 ORIG-1 TRAMADOL HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
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