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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2016

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 June 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/2016 CYKLOKAPRON
NDA #019281		 SUPPL-37 TRANEXAMIC ACID PFIZER Manufacturing (CMC) Approval
02/01/2016 INVIRASE
NDA #020628		 SUPPL-44 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Manufacturing (CMC) Approval
02/01/2016 EMEND
NDA #022023		 SUPPL-6 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Efficacy Approval
02/01/2016 PRAVASTATIN SODIUM
ANDA #076714		 SUPPL-8 PRAVASTATIN SODIUM DR REDDYS LABS INC Labeling Approval
02/01/2016 SERTRALINE HYDROCHLORIDE
ANDA #077162		 SUPPL-5 SERTRALINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
02/01/2016 CEFEPIME HYDROCHLORIDE
ANDA #203704		 ORIG-1 CEFEPIME HYDROCHLORIDE QILU Approval
02/01/2016 LEVETIRACETAM
ANDA #204312		 ORIG-1 LEVETIRACETAM EUGIA PHARMA Approval
02/01/2016 LIDOCAINE
ANDA #205318		 ORIG-1 LIDOCAINE ENCUBE Approval
02/01/2016 SAXENDA
NDA #206321		 SUPPL-2 LIRAGLUTIDE NOVO REMS Approval
02/01/2016 CELECOXIB
ANDA #206827		 ORIG-1 CELECOXIB AUROBINDO PHARMA Approval
02/01/2016 SPRITAM
NDA #207958		 SUPPL-2 LEVETIRACETAM APRECIA PHARMS Labeling Approval
02/02/2016 MATULANE
NDA #016785		 SUPPL-39 PROCARBAZINE HYDROCHLORIDE LEADIANT BIOSCI INC Manufacturing (CMC) Approval
02/02/2016 CYCLOSET
NDA #020866		 SUPPL-9 BROMOCRIPTINE MESYLATE VEROSCIENCE Labeling Approval
02/02/2016 FLUORESCITE
NDA #021980		 SUPPL-4 FLUORESCEIN SODIUM ALCON LABS INC Labeling Approval
02/02/2016 DEXILANT
NDA #022287		 SUPPL-20 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
02/02/2016 LISINOPRIL
ANDA #076164		 SUPPL-13 LISINOPRIL PRINSTON INC Labeling Approval
02/02/2016 LISINOPRIL
ANDA #076164		 SUPPL-14 LISINOPRIL PRINSTON INC Labeling Approval
02/02/2016 VENLAFAXINE HYDROCHLORIDE
ANDA #077166		 SUPPL-15 VENLAFAXINE HYDROCHLORIDE MYLAN Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #081048		 SUPPL-33 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #081049		 SUPPL-36 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #081050		 SUPPL-36 IMIPRAMINE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #083745		 SUPPL-122 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #084936		 SUPPL-108 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #084937		 SUPPL-128 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
02/02/2016 LEVETIRACETAM
ANDA #090079		 SUPPL-5 LEVETIRACETAM QUAGEN Labeling Approval
02/02/2016 LEVETIRACETAM
ANDA #090079		 SUPPL-6 LEVETIRACETAM QUAGEN Labeling Approval
02/02/2016 LEVETIRACETAM
ANDA #090079		 SUPPL-7 LEVETIRACETAM QUAGEN Labeling Approval
02/02/2016 LEVETIRACETAM
ANDA #090079		 SUPPL-8 LEVETIRACETAM QUAGEN Labeling Approval
02/02/2016 IMIPRAMINE HYDROCHLORIDE
ANDA #090441		 SUPPL-7 IMIPRAMINE HYDROCHLORIDE CHARTWELL Labeling Approval
02/02/2016 IMIPRAMINE PAMOATE
ANDA #091099		 SUPPL-3 IMIPRAMINE PAMOATE HIKMA Labeling Approval
02/02/2016 VENLAFAXINE HYDROCHLORIDE
ANDA #091123		 SUPPL-4 VENLAFAXINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
02/02/2016 VENLAFAXINE HYDROCHLORIDE
ANDA #091123		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
02/02/2016 VENLAFAXINE HYDROCHLORIDE
ANDA #091123		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
02/02/2016 ESCITALOPRAM OXALATE
ANDA #202221		 SUPPL-1 ESCITALOPRAM OXALATE HETERO LABS LTD III Labeling Approval
02/02/2016 ISOSULFAN BLUE
ANDA #206831		 ORIG-1 ISOSULFAN BLUE EUGIA PHARMA Approval
02/03/2016 METHOTREXATE LPF
NDA #011719		 SUPPL-124 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
02/03/2016 METHOTREXATE PRESERVATIVE FREE
NDA #011719		 SUPPL-124 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
02/03/2016 METHOTREXATE SODIUM
NDA #011719		 SUPPL-124 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
02/03/2016 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719		 SUPPL-124 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
02/03/2016 PRILOSEC
NDA #022056		 SUPPL-18 OMEPRAZOLE MAGNESIUM COVIS Efficacy Approval
02/03/2016 SOLODYN
NDA #050808		 SUPPL-18 MINOCYCLINE HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
02/03/2016 NYSTATIN
ANDA #062129		 SUPPL-10 NYSTATIN FOUGERA PHARMS Labeling Approval
02/03/2016 NIFEDIPINE
ANDA #090649		 SUPPL-13 NIFEDIPINE AUROBINDO PHARMA USA Labeling Approval
02/03/2016 GABAPENTIN
ANDA #090705		 SUPPL-9 GABAPENTIN INVAGEN PHARMS Labeling Approval
02/03/2016 GABAPENTIN
ANDA #090705		 SUPPL-11 GABAPENTIN INVAGEN PHARMS Labeling Approval
02/03/2016 GABAPENTIN
ANDA #090705		 SUPPL-12 GABAPENTIN INVAGEN PHARMS Labeling Approval
02/03/2016 CIMZIA
BLA #125160		 SUPPL-268 CERTOLIZUMAB PEGOL UCB INC Approval
02/03/2016 CEFAZOLIN SODIUM
ANDA #201654		 ORIG-1 CEFAZOLIN SODIUM HOSPIRA Approval
02/03/2016 ZOLMITRIPTAN
ANDA #202890		 SUPPL-2 ZOLMITRIPTAN ZYDUS PHARMS USA INC Labeling Approval
02/03/2016 TETRABENAZINE
ANDA #204574		 ORIG-1 TETRABENAZINE HETERO LABS LTD V Approval
02/03/2016 AMMONIA N 13
ANDA #207025		 ORIG-1 AMMONIA N-13 GEN HOSP Approval
02/04/2016 KEPPRA
NDA #021035		 SUPPL-95 LEVETIRACETAM UCB INC Manufacturing (CMC) Approval
02/04/2016 ABSORICA
NDA #021951		 SUPPL-7 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
02/04/2016 CYANOKIT
NDA #022041		 SUPPL-1 HYDROXOCOBALAMIN BTG INTL Manufacturing (CMC) Approval
02/04/2016 CYANOKIT
NDA #022041		 SUPPL-16 HYDROXOCOBALAMIN BTG INTL Manufacturing (CMC) Approval
02/04/2016 AFINITOR
NDA #022334		 SUPPL-34 EVEROLIMUS NOVARTIS Labeling Approval
02/04/2016 AMNESTEEM
ANDA #075945		 SUPPL-32 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
02/04/2016 CLARAVIS
ANDA #076135		 SUPPL-36 ISOTRETINOIN TEVA PHARMS USA REMS Approval
02/04/2016 CLARAVIS
ANDA #076356		 SUPPL-33 ISOTRETINOIN TEVA PHARMS USA REMS Approval
02/04/2016 MYORISAN
ANDA #076485		 SUPPL-12 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
02/04/2016 BOTOX
BLA #103000		 SUPPL-5294 OnabotulinumtoxinA ALLERGAN Approval
02/04/2016 BOTOX COSMETIC
BLA #103000		 SUPPL-5294 OnabotulinumtoxinA ALLERGAN Approval
02/04/2016 ZENATANE
ANDA #202099		 SUPPL-5 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
02/04/2016 GABAPENTIN
ANDA #205101		 ORIG-1 GABAPENTIN SCIEGEN PHARMS INC Approval
02/04/2016 OFEV
NDA #205832		 SUPPL-1 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Labeling Approval
02/04/2016 PARICALCITOL
NDA #207174		 ORIG-1 PARICALCITOL ACCORD HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
02/05/2016 ANCOBON
NDA #017001		 SUPPL-31 FLUCYTOSINE BAUSCH Manufacturing (CMC) Approval
02/05/2016 DILAUDID
NDA #019891		 SUPPL-23 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
02/05/2016 AVAPRO
NDA #020757		 SUPPL-59 IRBESARTAN SANOFI AVENTIS US Labeling Approval
02/05/2016 AVAPRO
NDA #020757		 SUPPL-67 IRBESARTAN SANOFI AVENTIS US Labeling Approval
02/05/2016 AVALIDE
NDA #020758		 SUPPL-70 HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US Labeling Approval
02/05/2016 RELISTOR
NDA #021964		 SUPPL-16 METHYLNALTREXONE BROMIDE SALIX PHARMS Manufacturing (CMC) Approval
02/05/2016 TACLONEX
NDA #022185		 SUPPL-22 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
02/05/2016 TACLONEX
NDA #022185		 SUPPL-22 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
02/05/2016 BEPREVE
NDA #022288		 SUPPL-5 BEPOTASTINE BESILATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
02/05/2016 OZURDEX
NDA #022315		 SUPPL-11 DEXAMETHASONE ABBVIE Manufacturing (CMC) Approval
02/05/2016 ETODOLAC
ANDA #075696		 SUPPL-14 ETODOLAC ACTAVIS ELIZABETH Labeling Approval
02/05/2016 RANITIDINE HYDROCHLORIDE
ANDA #076195		 SUPPL-23 RANITIDINE HYDROCHLORIDE PERRIGO Manufacturing (CMC) Approval
02/05/2016 BALSALAZIDE DISODIUM
ANDA #077883		 SUPPL-3 BALSALAZIDE DISODIUM APOTEX INC Labeling Approval
02/05/2016 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090011		 SUPPL-4 AMLODIPINE BESYLATE; VALSARTAN STRIDES PHARMA Labeling Approval
02/05/2016 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090011		 SUPPL-5 AMLODIPINE BESYLATE; VALSARTAN STRIDES PHARMA Labeling Approval
02/05/2016 LINEZOLID
ANDA #091210		 ORIG-1 LINEZOLID GATE PHARMS Approval
02/05/2016 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201593		 SUPPL-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TORRENT Labeling Approval
02/05/2016 RAYOS
NDA #202020		 SUPPL-9 PREDNISONE HORIZON Manufacturing (CMC) Approval
02/05/2016 JARDIANCE
NDA #204629		 SUPPL-4 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
02/05/2016 IBANDRONATE SODIUM
ANDA #206058		 ORIG-1 IBANDRONATE SODIUM ACCORD HLTHCARE Approval
02/05/2016 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206340		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Approval
02/05/2016 DAKLINZA
NDA #206843		 SUPPL-1 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Efficacy Approval
02/05/2016 DAKLINZA
NDA #206843		 SUPPL-2 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Efficacy Approval
02/05/2016 DAKLINZA
NDA #206843		 SUPPL-3 DACLATASVIR DIHYDROCHLORIDE BRISTOL-MYERS SQUIBB Efficacy Approval
02/05/2016 SERNIVO
NDA #208079		 ORIG-1 BETAMETHASONE DIPROPIONATE PRIMUS PHARMS Type 3 - New Dosage Form Approval
02/08/2016 LOTREL
NDA #020364		 SUPPL-62 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/08/2016 CAVERJECT
NDA #020379		 SUPPL-21 ALPROSTADIL PFIZER Manufacturing (CMC) Approval
02/08/2016 OMEPRAZOLE
NDA #022032		 SUPPL-31 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
02/08/2016 CUVPOSA
NDA #022571		 SUPPL-5 GLYCOPYRROLATE MERZ PHARMS Manufacturing (CMC) Approval
02/08/2016 QUINAPRIL HYDROCHLORIDE
ANDA #076240		 SUPPL-12 QUINAPRIL HYDROCHLORIDE APOTEX INC Labeling Approval
02/08/2016 IBUPROFEN
ANDA #091237		 SUPPL-2 IBUPROFEN MARKSANS PHARMA Manufacturing (CMC) Approval
02/08/2016 XELJANZ
NDA #203214		 SUPPL-13 TOFACITINIB CITRATE PF PRISM CV REMS Approval
02/08/2016 CLINOLIPID 20%
NDA #204508		 SUPPL-4 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/08/2016 IMBRUVICA
NDA #205552		 SUPPL-8 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
02/08/2016 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206083		 ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN PRINSTON INC Approval
02/09/2016 RISPERDAL
NDA #020272		 SUPPL-76 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
02/09/2016 ATACAND
NDA #020838		 SUPPL-39 CANDESARTAN CILEXETIL ANI PHARMS Labeling Approval
02/09/2016 ATACAND HCT
NDA #021093		 SUPPL-19 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
02/09/2016 RITALIN LA
NDA #021284		 SUPPL-31 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
02/09/2016 SUMATRIPTAN SUCCINATE
ANDA #090358		 SUPPL-3 SUMATRIPTAN SUCCINATE SUN PHARM Labeling Approval
02/09/2016 SUMATRIPTAN SUCCINATE
ANDA #090358		 SUPPL-9 SUMATRIPTAN SUCCINATE SUN PHARM Labeling Approval
02/09/2016 SUMATRIPTAN SUCCINATE
ANDA #090358		 SUPPL-11 SUMATRIPTAN SUCCINATE SUN PHARM Labeling Approval
02/09/2016 COMPLERA
NDA #202123		 SUPPL-23 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/09/2016 ZOLEDRONIC ACID
ANDA #203344		 ORIG-1 ZOLEDRONIC ACID PFIZER INC Tentative Approval
02/09/2016 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204023		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE ACCORD HLTHCARE Approval
02/09/2016 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ANDA #204704		 ORIG-1 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE XIROMED Approval
02/09/2016 DEXMEDETOMIDINE HYDROCHLORIDE
NDA #206628		 SUPPL-1 DEXMEDETOMIDINE HYDROCHLORIDE HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/09/2016 BUPROPION HYDROCHLORIDE
ANDA #206674		 ORIG-1 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Approval
02/10/2016 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-14 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
02/10/2016 GONAL-F
BLA #021765		 SUPPL-40 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/10/2016 GONAL-F RFF
BLA #021765		 SUPPL-40 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/10/2016 OMEPRAZOLE
NDA #022032		 SUPPL-32 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
02/10/2016 AZITHROMYCIN
ANDA #065360		 SUPPL-7 AZITHROMYCIN AUROBINDO PHARMA USA Labeling Approval
02/10/2016 FLUTICASONE PROPIONATE
ANDA #076504		 SUPPL-10 FLUTICASONE PROPIONATE HIKMA Labeling Approval
02/10/2016 CLONAZEPAM
ANDA #077856		 SUPPL-11 CLONAZEPAM PRINSTON INC Labeling Approval
02/10/2016 LEVETIRACETAM
ANDA #078797		 SUPPL-2 LEVETIRACETAM WATSON LABS INC Labeling Approval
02/10/2016 LEVETIRACETAM
ANDA #078918		 SUPPL-7 LEVETIRACETAM ZYDUS PHARMS USA INC Labeling Approval
02/10/2016 COLISTIMETHATE SODIUM
ANDA #202359		 SUPPL-2 COLISTIMETHATE SODIUM AVET LIFESCIENCES Labeling Approval
02/10/2016 TEMOZOLOMIDE
ANDA #203898		 ORIG-1 TEMOZOLOMIDE CHARTWELL MOLECULAR Approval
02/10/2016 SIRTURO
NDA #204384		 SUPPL-7 BEDAQUILINE FUMARATE JANSSEN THERAP Manufacturing (CMC) Approval
02/10/2016 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206919		 ORIG-1 LEVOFLOXACIN EUGIA PHARMA Approval
02/10/2016 TAGRISSO
NDA #208065		 SUPPL-1 OSIMERTINIB MESYLATE ASTRAZENECA Manufacturing (CMC) Approval
02/11/2016 DESOGEN
NDA #020071		 SUPPL-20 DESOGESTREL; ETHINYL ESTRADIOL ORGANON USA INC Manufacturing (CMC) Approval
02/11/2016 LUPRON DEPOT
NDA #020517		 SUPPL-37 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Manufacturing (CMC) Approval
02/11/2016 GLUCAGEN
NDA #020918		 SUPPL-47 GLUCAGON HYDROCHLORIDE NOVO NORDISK Manufacturing (CMC) Approval
02/11/2016 BENICAR HCT
NDA #021532		 SUPPL-15 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
02/11/2016 ATRIPLA
NDA #021937		 SUPPL-39 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Labeling Approval
02/11/2016 CLINDESSE
NDA #050793		 SUPPL-20 CLINDAMYCIN PHOSPHATE PADAGIS US Manufacturing (CMC) Approval
02/11/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374		 SUPPL-7 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
02/11/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374		 SUPPL-8 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
02/11/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374		 SUPPL-9 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
02/11/2016 MESNA
ANDA #076488		 SUPPL-3 MESNA MYLAN INSTITUTIONAL Labeling Approval
02/11/2016 JENTADUETO
NDA #201281		 SUPPL-11 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
02/11/2016 EPINEPHRINE
NDA #205029		 SUPPL-2 EPINEPHRINE BPI LABS Efficacy Approval
02/12/2016 TECHNELITE
NDA #017771		 SUPPL-38 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR LANTHEUS MEDCL Manufacturing (CMC) Approval
02/12/2016 FENTANYL CITRATE
NDA #019101		 SUPPL-43 FENTANYL CITRATE HIKMA Manufacturing (CMC) Approval
02/12/2016 ELIMITE
NDA #019855		 SUPPL-10 PERMETHRIN AUROBINDO PHARMA USA Manufacturing (CMC) Approval
02/12/2016 DILAUDID
NDA #019891		 SUPPL-21 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
02/12/2016 DILAUDID
NDA #019891		 SUPPL-22 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
02/12/2016 LOTENSIN HCT
NDA #020033		 SUPPL-53 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Manufacturing (CMC) Approval
02/12/2016 PROVENTIL-HFA
NDA #020503		 SUPPL-50 ALBUTEROL SULFATE KINDEVA Manufacturing (CMC) Approval
02/12/2016 LAMISIL
NDA #020539		 SUPPL-25 TERBINAFINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
02/12/2016 CLARITIN
NDA #020641		 SUPPL-41 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/12/2016 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-41 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
02/12/2016 TEMODAR
NDA #021029		 SUPPL-31 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
02/12/2016 ULORIC
NDA #021856		 SUPPL-9 FEBUXOSTAT TAKEDA PHARMS USA Manufacturing (CMC) Approval
02/12/2016 EXFORGE
NDA #021990		 SUPPL-28 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
02/12/2016 TEMODAR
NDA #022277		 SUPPL-11 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
02/12/2016 EXFORGE HCT
NDA #022314		 SUPPL-22 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
02/12/2016 MULTAQ
NDA #022425		 SUPPL-27 DRONEDARONE HYDROCHLORIDE SANOFI AVENTIS US REMS Approval
02/12/2016 DALIRESP
NDA #022522		 SUPPL-7 ROFLUMILAST ASTRAZENECA Manufacturing (CMC) Approval
02/12/2016 ALENDRONATE SODIUM
ANDA #076768		 SUPPL-4 ALENDRONATE SODIUM CIPLA Labeling Approval
02/12/2016 ALENDRONATE SODIUM
ANDA #076768		 SUPPL-6 ALENDRONATE SODIUM CIPLA Labeling Approval
02/12/2016 CHLOROQUINE PHOSPHATE
ANDA #090610		 SUPPL-3 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
02/12/2016 CANDESARTAN CILEXETIL
ANDA #202079		 SUPPL-2 CANDESARTAN CILEXETIL APOTEX Labeling Approval
02/12/2016 ROSUVASTATIN ZINC
NDA #202172		 ORIG-1 ROSUVASTATIN ZINC WATSON LABS INC Type 2 - New Active Ingredient Tentative Approval
02/12/2016 AMPICILLIN AND SULBACTAM
ANDA #202197		 SUPPL-1 AMPICILLIN SODIUM; SULBACTAM SODIUM STERISCIENCE Labeling Approval
02/12/2016 LEVETIRACETAM
ANDA #202533		 SUPPL-3 LEVETIRACETAM PRINSTON INC Labeling Approval
02/12/2016 LEVETIRACETAM
ANDA #202533		 SUPPL-4 LEVETIRACETAM PRINSTON INC Labeling Approval
02/12/2016 LEVETIRACETAM
ANDA #202533		 SUPPL-7 LEVETIRACETAM PRINSTON INC Labeling Approval
02/12/2016 LEVETIRACETAM
ANDA #202533		 SUPPL-9 LEVETIRACETAM PRINSTON INC Labeling Approval
02/12/2016 SUBSYS
NDA #202788		 SUPPL-14 FENTANYL BTCP PHARMA Manufacturing (CMC) Approval
02/12/2016 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #202884		 SUPPL-4 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE APOTEX INC Labeling Approval
02/12/2016 HARVONI
NDA #205834		 SUPPL-7 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
02/12/2016 HARVONI
NDA #205834		 SUPPL-8 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
02/12/2016 HARVONI
NDA #205834		 SUPPL-9 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
02/12/2016 ENTRESTO
NDA #207620		 SUPPL-1 SACUBITRIL; VALSARTAN NOVARTIS PHARMS CORP Manufacturing (CMC) Approval
02/15/2016 CARBIDOPA AND LEVODOPA
ANDA #074260		 SUPPL-44 CARBIDOPA; LEVODOPA ACTAVIS ELIZABETH Labeling Approval
02/15/2016 LEFLUNOMIDE
ANDA #077086		 SUPPL-14 LEFLUNOMIDE HERITAGE PHARMS Labeling Approval
02/16/2016 KLARON
NDA #019931		 SUPPL-24 SULFACETAMIDE SODIUM BAUSCH Manufacturing (CMC) Approval
02/16/2016 VIREAD
NDA #021356		 SUPPL-52 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/16/2016 VIREAD
NDA #022577		 SUPPL-9 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/16/2016 VANCOMYCIN HYDROCHLORIDE
ANDA #062663		 SUPPL-42 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/16/2016 VANCOMYCIN HYDROCHLORIDE
ANDA #062663		 SUPPL-55 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/16/2016 VANCOMYCIN HYDROCHLORIDE
ANDA #062663		 SUPPL-57 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/16/2016 SUPRAX
ANDA #065130		 SUPPL-18 CEFIXIME LUPIN PHARMS Labeling Approval
02/16/2016 SUPRAX
ANDA #065380		 SUPPL-4 CEFIXIME LUPIN LTD Labeling Approval
02/16/2016 CAPTOPRIL
ANDA #074737		 SUPPL-9 CAPTOPRIL COREPHARMA Labeling Approval
02/16/2016 CAPTOPRIL
ANDA #074737		 SUPPL-10 CAPTOPRIL COREPHARMA Labeling Approval
02/16/2016 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #076648		 SUPPL-8 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE AUROBINDO PHARMA USA Labeling Approval
02/16/2016 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #076852		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE IMPAX LABS Approval
02/16/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077093		 SUPPL-15 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE MYLAN Labeling Approval
02/16/2016 RAMIPRIL
ANDA #077626		 SUPPL-18 RAMIPRIL LUPIN Labeling Approval
02/16/2016 STAVUDINE
ANDA #078030		 SUPPL-4 STAVUDINE CIPLA LTD Labeling Approval
02/16/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078450		 SUPPL-15 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
02/16/2016 DIVALPROEX SODIUM
ANDA #078791		 SUPPL-9 DIVALPROEX SODIUM IMPAX LABS Labeling Approval
02/16/2016 TOPOTECAN HYDROCHLORIDE
ANDA #091199		 SUPPL-1 TOPOTECAN HYDROCHLORIDE TEYRO LABS Labeling Approval
02/16/2016 TOPOTECAN HYDROCHLORIDE
ANDA #091199		 SUPPL-2 TOPOTECAN HYDROCHLORIDE TEYRO LABS Labeling Approval
02/16/2016 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #091524		 SUPPL-7 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE APOTEX Labeling Approval
02/16/2016 NITROFURANTOIN
ANDA #201722		 ORIG-1 NITROFURANTOIN, MACROCRYSTALLINE SUN PHARM INDUSTRIES Approval
02/16/2016 LISINOPRIL
ANDA #202554		 SUPPL-2 LISINOPRIL ACCORD HLTHCARE Labeling Approval
02/16/2016 LISINOPRIL
ANDA #202554		 SUPPL-3 LISINOPRIL ACCORD HLTHCARE Labeling Approval
02/16/2016 LISINOPRIL
ANDA #202554		 SUPPL-4 LISINOPRIL ACCORD HLTHCARE Labeling Approval
02/16/2016 LISINOPRIL
ANDA #202554		 SUPPL-5 LISINOPRIL ACCORD HLTHCARE Labeling Approval
02/16/2016 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #202691		 ORIG-1 METHYLPREDNISOLONE SODIUM SUCCINATE HIKMA Approval
02/16/2016 DESVENLAFAXINE SUCCINATE
ANDA #204082		 ORIG-1 DESVENLAFAXINE SUCCINATE HIKMA Approval
02/16/2016 DESVENLAFAXINE SUCCINATE
ANDA #204083		 ORIG-1 DESVENLAFAXINE SUCCINATE HIKMA Approval
02/16/2016 BREO ELLIPTA
NDA #204275		 SUPPL-9 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Labeling Approval
02/16/2016 TOUJEO MAX SOLOSTAR
BLA #206538		 SUPPL-2 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
02/16/2016 TOUJEO SOLOSTAR
BLA #206538		 SUPPL-2 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
02/17/2016 KINEVAC
NDA #017697		 SUPPL-27 SINCALIDE BRACCO Manufacturing (CMC) Approval
02/17/2016 AFREZZA
BLA #022472		 SUPPL-9 INSULIN RECOMBINANT HUMAN MANNKIND Approval
02/17/2016 EFAVIRENZ
ANDA #091471		 ORIG-1 EFAVIRENZ MYLAN Approval
02/17/2016 AMPICILLIN AND SULBACTAM
ANDA #201024		 SUPPL-1 AMPICILLIN SODIUM; SULBACTAM SODIUM STERISCIENCE Labeling Approval
02/17/2016 FLUOROURACIL
ANDA #203609		 ORIG-1 FLUOROURACIL SAGENT PHARMS INC Approval
02/17/2016 OPSUMIT
NDA #204410		 SUPPL-6 MACITENTAN ACTELION Labeling Approval
02/17/2016 ODOMZO
NDA #205266		 SUPPL-3 SONIDEGIB PHOSPHATE SUN PHARM Labeling Approval
02/17/2016 CARBIDOPA
ANDA #205304		 ORIG-1 CARBIDOPA EDENBRIDGE PHARMS Approval
02/17/2016 HARVONI
NDA #205834		 SUPPL-11 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
02/18/2016 VISTARIL
NDA #011459		 SUPPL-50 HYDROXYZINE PAMOATE PFIZER Labeling Approval
02/18/2016 VISTARIL
NDA #011795		 SUPPL-27 HYDROXYZINE PAMOATE PFIZER Labeling Approval
02/18/2016 DEPAKENE
NDA #018081		 SUPPL-64 VALPROIC ACID ABBVIE Labeling Approval
02/18/2016 DEPAKENE
NDA #018082		 SUPPL-47 VALPROIC ACID ABBVIE Labeling Approval
02/18/2016 DEPAKOTE
NDA #018723		 SUPPL-56 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/18/2016 DEPAKOTE
NDA #019680		 SUPPL-43 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/18/2016 DEPACON
NDA #020593		 SUPPL-34 VALPROATE SODIUM ABBVIE Labeling Approval
02/18/2016 DEPAKOTE ER
NDA #021168		 SUPPL-33 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/18/2016 STALEVO 100
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 STALEVO 125
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 STALEVO 150
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 STALEVO 200
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 STALEVO 50
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 STALEVO 75
NDA #021485		 SUPPL-35 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/18/2016 AFINITOR
NDA #022334		 SUPPL-35 EVEROLIMUS NOVARTIS Efficacy Approval
02/18/2016 FENOPROFEN CALCIUM
ANDA #072274		 SUPPL-23 FENOPROFEN CALCIUM ANI PHARMS Labeling Approval
02/18/2016 PIROXICAM
ANDA #074102		 SUPPL-13 PIROXICAM MYLAN Labeling Approval
02/18/2016 ENALAPRIL MALEATE
ANDA #075459		 SUPPL-9 ENALAPRIL MALEATE SANDOZ INC Labeling Approval
02/18/2016 ENALAPRIL MALEATE
ANDA #075496		 SUPPL-9 ENALAPRIL MALEATE SANDOZ INC Labeling Approval
02/18/2016 CARVEDILOL
ANDA #076373		 SUPPL-15 CARVEDILOL TEVA Labeling Approval
02/18/2016 LISINOPRIL
ANDA #077321		 SUPPL-35 LISINOPRIL LUPIN Labeling Approval
02/18/2016 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-7 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
02/18/2016 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-26 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
02/18/2016 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-7 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
02/18/2016 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-8 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
02/18/2016 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-9 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
02/18/2016 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-10 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
02/18/2016 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-11 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
02/18/2016 CAPECITABINE
ANDA #090943		 SUPPL-3 CAPECITABINE RISING Labeling Approval
02/18/2016 FONDAPARINUX SODIUM
ANDA #091316		 SUPPL-3 FONDAPARINUX SODIUM DR REDDYS LABS LTD Labeling Approval
02/18/2016 CAPECITABINE
ANDA #091649		 SUPPL-4 CAPECITABINE TEVA PHARMS USA Labeling Approval
02/18/2016 CAPECITABINE
ANDA #091649		 SUPPL-5 CAPECITABINE TEVA PHARMS USA Labeling Approval
02/18/2016 SIROLIMUS
ANDA #201676		 SUPPL-1 SIROLIMUS ZYDUS PHARMS Labeling Approval
02/18/2016 SIROLIMUS
ANDA #201676		 SUPPL-2 SIROLIMUS ZYDUS PHARMS Labeling Approval
02/18/2016 SIROLIMUS
ANDA #201676		 SUPPL-3 SIROLIMUS ZYDUS PHARMS Labeling Approval
02/18/2016 SIROLIMUS
ANDA #201676		 SUPPL-4 SIROLIMUS ZYDUS PHARMS Labeling Approval
02/18/2016 SIROLIMUS
ANDA #201676		 SUPPL-5 SIROLIMUS ZYDUS PHARMS Labeling Approval
02/18/2016 RIZATRIPTAN BENZOATE
ANDA #203269		 ORIG-1 RIZATRIPTAN BENZOATE ALKEM LABS LTD Approval
02/18/2016 VERSACLOZ
NDA #203479		 SUPPL-6 CLOZAPINE TASMAN PHARMA Manufacturing (CMC) Approval
02/18/2016 LISINOPRIL
ANDA #203508		 SUPPL-5 LISINOPRIL INVAGEN PHARMS Labeling Approval
02/18/2016 GABAPENTIN
ANDA #204989		 ORIG-1 GABAPENTIN SCIEGEN PHARMS INC Approval
02/18/2016 DOXYCYCLINE
ANDA #205115		 ORIG-1 DOXYCYCLINE ZYDUS PHARMS Approval
02/18/2016 DANTROLENE SODIUM
ANDA #205239		 ORIG-1 DANTROLENE SODIUM EUGIA PHARMA SPECLTS Approval
02/18/2016 BRIVIACT
NDA #205836		 ORIG-1 BRIVARACETAM UCB INC Type 1 - New Molecular Entity Approval
02/18/2016 BRIVIACT
NDA #205837		 ORIG-1 BRIVARACETAM UCB INC Type 3 - New Dosage Form Approval
02/18/2016 BRIVIACT
NDA #205838		 ORIG-1 BRIVARACETAM UCB INC Type 3 - New Dosage Form Approval
02/18/2016 SODIUM POLYSTYRENE SULFONATE
ANDA #206815		 ORIG-1 SODIUM POLYSTYRENE SULFONATE CHARTWELL RX Approval
02/19/2016 MYSOLINE
NDA #009170		 SUPPL-39 PRIMIDONE VALEANT Manufacturing (CMC) Approval
02/19/2016 HUMULIN N
BLA #018781		 SUPPL-160 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/19/2016 NUVARING
NDA #021187		 SUPPL-20 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Manufacturing (CMC) Approval
02/19/2016 PREZISTA
NDA #021976		 SUPPL-38 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
02/19/2016 GILENYA
NDA #022527		 SUPPL-18 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
02/19/2016 PRIMAXIN
NDA #050587		 SUPPL-77 CILASTATIN SODIUM; IMIPENEM MERCK Manufacturing (CMC) Approval
02/19/2016 AMPICILLIN AND SULBACTAM
ANDA #065241		 SUPPL-13 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
02/19/2016 METRONIDAZOLE
ANDA #070772		 SUPPL-38 METRONIDAZOLE INNOGENIX Manufacturing (CMC) Approval
02/19/2016 GEMFIBROZIL
ANDA #074270		 SUPPL-15 GEMFIBROZIL CHARTWELL MOLECULES Labeling Approval
02/19/2016 MEMANTINE HYDROCHLORIDE
ANDA #090048		 SUPPL-2 MEMANTINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/19/2016 TRANEXAMIC ACID
ANDA #091596		 SUPPL-2 TRANEXAMIC ACID FRESENIUS KABI USA Labeling Approval
02/19/2016 LEVETIRACETAM
ANDA #201293		 SUPPL-1 LEVETIRACETAM CHARTWELL RX Labeling Approval
02/19/2016 LEVETIRACETAM
ANDA #201293		 SUPPL-2 LEVETIRACETAM CHARTWELL RX Manufacturing (CMC) Approval
02/19/2016 TRANEXAMIC ACID
ANDA #202373		 SUPPL-1 TRANEXAMIC ACID EPIC PHARMA LLC Labeling Approval
02/19/2016 STRIBILD
NDA #203100		 SUPPL-21 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/19/2016 CEFOTAXIME SODIUM
ANDA #203132		 ORIG-1 CEFOTAXIME SODIUM HOSPIRA Approval
02/19/2016 DONEPEZIL HYDROCHLORIDE
ANDA #203713		 ORIG-1 DONEPEZIL HYDROCHLORIDE DEXCEL Approval
02/19/2016 SUMATRIPTAN
ANDA #204841		 ORIG-1 SUMATRIPTAN LANNETT CO INC Approval
02/19/2016 MEMANTINE HYDROCHLORIDE
ANDA #206310		 ORIG-1 MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Tentative Approval
02/19/2016 IBUPROFEN SODIUM
ANDA #206581		 SUPPL-1 IBUPROFEN SODIUM PERRIGO R AND D Manufacturing (CMC) Approval
02/19/2016 IBRANCE
NDA #207103		 SUPPL-2 PALBOCICLIB PFIZER Efficacy Approval
02/19/2016 TUZISTRA XR
NDA #207768		 SUPPL-2 CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX TRIS PHARMA INC Manufacturing (CMC) Approval
02/20/2016 TIZANIDINE HYDROCHLORIDE
ANDA #076280		 SUPPL-20 TIZANIDINE HYDROCHLORIDE CASI PHARMS INC Labeling Approval
02/20/2016 TERCONAZOLE
ANDA #076712		 SUPPL-9 TERCONAZOLE FOUGERA PHARMS Labeling Approval
02/20/2016 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-12 DIVALPROEX SODIUM TEVA Labeling Approval
02/20/2016 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-13 DIVALPROEX SODIUM TEVA Labeling Approval
02/20/2016 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-14 DIVALPROEX SODIUM TEVA Labeling Approval
02/20/2016 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-15 DIVALPROEX SODIUM TEVA Labeling Approval
02/20/2016 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-16 DIVALPROEX SODIUM TEVA Labeling Approval
02/20/2016 TERCONAZOLE
ANDA #077149		 SUPPL-4 TERCONAZOLE PADAGIS ISRAEL Labeling Approval
02/20/2016 HELIUM, USP
NDA #209033		 ORIG-1 HELIUM NEXAIR LLC Medical Gas Approval
02/22/2016 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #018561		 SUPPL-57 DEXTROSE ICU MEDICAL INC Labeling Approval
02/22/2016 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #018562		 SUPPL-56 DEXTROSE ICU MEDICAL INC Labeling Approval
02/22/2016 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #018563		 SUPPL-57 DEXTROSE ICU MEDICAL INC Labeling Approval
02/22/2016 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #018564		 SUPPL-59 DEXTROSE ICU MEDICAL INC Labeling Approval
02/22/2016 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #019345		 SUPPL-44 DEXTROSE ICU MEDICAL INC Labeling Approval
02/22/2016 COMTAN
NDA #020796		 SUPPL-26 ENTACAPONE ORION PHARMA Labeling Approval
02/22/2016 SOMAVERT
BLA #021106		 SUPPL-46 PEGVISOMANT PHARMACIA Approval
02/22/2016 STALEVO 100
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 STALEVO 125
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 STALEVO 150
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 STALEVO 200
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 STALEVO 50
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 STALEVO 75
NDA #021485		 SUPPL-33 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
02/22/2016 SIMPONI ARIA
BLA #125433		 SUPPL-17 GOLIMUMAB JANSSEN BIOTECH Approval
02/22/2016 MORPHINE SULFATE
NDA #201517		 SUPPL-8 MORPHINE SULFATE CHARTWELL MOLECULAR Manufacturing (CMC) Approval
02/22/2016 OPANA ER
NDA #201655		 SUPPL-19 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
02/22/2016 OPSUMIT
NDA #204410		 SUPPL-7 MACITENTAN ACTELION REMS Approval
02/23/2016 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016367		 SUPPL-220 DEXTROSE ICU MEDICAL INC Manufacturing (CMC) Approval
02/23/2016 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040432		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
02/23/2016 CAPTOPRIL
ANDA #074505		 SUPPL-28 CAPTOPRIL HIKMA INTL PHARMS Labeling Approval
02/23/2016 CAPTOPRIL
ANDA #074505		 SUPPL-30 CAPTOPRIL HIKMA INTL PHARMS Labeling Approval
02/23/2016 RANITIDINE HYDROCHLORIDE
ANDA #075294		 SUPPL-31 RANITIDINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/23/2016 RANITIDINE HYDROCHLORIDE
ANDA #075294		 SUPPL-32 RANITIDINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/23/2016 SULFASALAZINE
ANDA #075339		 SUPPL-17 SULFASALAZINE NUVO PHARMS INC Labeling Approval
02/23/2016 TERCONAZOLE
ANDA #077553		 SUPPL-4 TERCONAZOLE TARO Labeling Approval
02/23/2016 TERCONAZOLE
ANDA #077553		 SUPPL-5 TERCONAZOLE TARO Labeling Approval
02/23/2016 ZIPRASIDONE HYDROCHLORIDE
ANDA #077560		 SUPPL-11 ZIPRASIDONE HYDROCHLORIDE LUPIN PHARMS Labeling Approval
02/23/2016 TIZANIDINE HYDROCHLORIDE
ANDA #078868		 SUPPL-1 TIZANIDINE HYDROCHLORIDE APOTEX INC Labeling Approval
02/23/2016 GLYCOPYRROLATE
ANDA #091182		 SUPPL-1 GLYCOPYRROLATE INDOCO Labeling Approval
02/23/2016 TIZANIDINE HYDROCHLORIDE
ANDA #091502		 SUPPL-1 TIZANIDINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
02/23/2016 COMPLERA
NDA #202123		 SUPPL-21 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
02/23/2016 COMPLERA
NDA #202123		 SUPPL-24 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/23/2016 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #204057		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE GLENMARK PHARMS Approval
02/23/2016 LEVETIRACETAM
ANDA #204511		 ORIG-1 LEVETIRACETAM ANDA REPOSITORY Approval
02/23/2016 DICLOFENAC POTASSIUM
ANDA #204648		 ORIG-1 DICLOFENAC POTASSIUM BIONPHARMA Approval
02/23/2016 SODIUM POLYSTYRENE SULFONATE
ANDA #205727		 ORIG-1 SODIUM POLYSTYRENE SULFONATE BELCHER Approval
02/23/2016 XELJANZ XR
NDA #208246		 ORIG-1 TOFACITINIB CITRATE PFIZER Type 3 - New Dosage Form Approval
02/24/2016 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017427		 SUPPL-76 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/24/2016 ULTRAVATE
NDA #019967		 SUPPL-17 HALOBETASOL PROPIONATE SUN PHARM INDS INC Manufacturing (CMC) Approval
02/24/2016 DEPO-PROVERA
NDA #020246		 SUPPL-40 MEDROXYPROGESTERONE ACETATE PFIZER Manufacturing (CMC) Approval
02/24/2016 FOSRENOL
NDA #021468		 SUPPL-20 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
02/24/2016 QUTENZA
NDA #022395		 SUPPL-16 CAPSAICIN AVERITAS Manufacturing (CMC) Approval
02/24/2016 TRAZODONE HYDROCHLORIDE
ANDA #071523		 SUPPL-47 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Manufacturing (CMC) Approval
02/24/2016 LISINOPRIL
ANDA #075743		 SUPPL-13 LISINOPRIL PRINSTON INC Manufacturing (CMC) Approval
02/24/2016 RIBAVIRIN
ANDA #076277		 SUPPL-10 RIBAVIRIN TEVA Labeling Approval
02/24/2016 RIBAVIRIN
ANDA #076277		 SUPPL-11 RIBAVIRIN TEVA Labeling Approval
02/24/2016 PREVIFEM
ANDA #076334		 SUPPL-19 ETHINYL ESTRADIOL; NORGESTIMATE ENDO OPERATIONS Labeling Approval
02/24/2016 PREVIFEM
ANDA #076334		 SUPPL-22 ETHINYL ESTRADIOL; NORGESTIMATE ENDO OPERATIONS Labeling Approval
02/24/2016 TRI-PREVIFEM
ANDA #076335		 SUPPL-16 ETHINYL ESTRADIOL; NORGESTIMATE ENDO OPERATIONS Manufacturing (CMC) Approval
02/24/2016 TRI-PREVIFEM
ANDA #076335		 SUPPL-19 ETHINYL ESTRADIOL; NORGESTIMATE ENDO OPERATIONS Labeling Approval
02/24/2016 ATORVASTATIN CALCIUM
ANDA #091650		 SUPPL-7 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
02/24/2016 LAMOTRIGINE
ANDA #202887		 SUPPL-1 LAMOTRIGINE RUBICON Labeling Approval
02/24/2016 LAMOTRIGINE
ANDA #202887		 SUPPL-2 LAMOTRIGINE RUBICON Labeling Approval
02/24/2016 LAMOTRIGINE
ANDA #202887		 SUPPL-3 LAMOTRIGINE RUBICON Labeling Approval
02/24/2016 LAMOTRIGINE
ANDA #202887		 SUPPL-4 LAMOTRIGINE RUBICON Labeling Approval
02/24/2016 ANORO ELLIPTA
NDA #203975		 SUPPL-3 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Labeling Approval
02/24/2016 RIVASTIGMINE
ANDA #204403		 SUPPL-1 RIVASTIGMINE ALVOGEN Manufacturing (CMC) Approval
02/24/2016 RIVASTIGMINE
ANDA #204403		 SUPPL-2 RIVASTIGMINE ALVOGEN Manufacturing (CMC) Approval
02/24/2016 FOSRENOL
NDA #204734		 SUPPL-1 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
02/24/2016 INCRUSE ELLIPTA
NDA #205382		 SUPPL-2 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Efficacy Approval
02/24/2016 PARICALCITOL
ANDA #206710		 ORIG-1 PARICALCITOL LOTUS PHARM CO LTD Approval
02/24/2016 SODIUM PHENYLACETATE AND SODIUM BENZOATE
ANDA #207096		 ORIG-1 SODIUM BENZOATE; SODIUM PHENYLACETATE AILEX PHARMS LLC Approval
02/24/2016 ACZONE
NDA #207154		 ORIG-1 DAPSONE ALMIRALL Type 5 - New Formulation or New Manufacturer Approval
02/25/2016 SOLU-CORTEF
NDA #009866		 SUPPL-108 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
02/25/2016 SURVANTA
BLA #020032		 SUPPL-43 BERACTANT ABBVIE Approval
02/25/2016 ALEVE
NDA #020204		 SUPPL-48 NAPROXEN SODIUM BAYER Manufacturing (CMC) Approval
02/25/2016 PREMPHASE 14/14
NDA #020527		 SUPPL-61 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Manufacturing (CMC) Approval
02/25/2016 PREMPRO
NDA #020527		 SUPPL-61 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Manufacturing (CMC) Approval
02/25/2016 STALEVO 100
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 STALEVO 125
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 STALEVO 150
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 STALEVO 200
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 STALEVO 50
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 STALEVO 75
NDA #021485		 SUPPL-36 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Manufacturing (CMC) Approval
02/25/2016 ELESTAT
NDA #021565		 SUPPL-8 EPINASTINE HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
02/25/2016 TRUVADA
NDA #021752		 SUPPL-50 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Labeling Approval
02/25/2016 ELELYSO
BLA #022458		 SUPPL-5 TALIGLUCERASE ALFA PFIZER Approval
02/25/2016 OMEPRAZOLE
ANDA #075410		 SUPPL-51 OMEPRAZOLE LANNETT CO INC Labeling Approval
02/25/2016 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-13 ENALAPRIL MALEATE TARO Labeling Approval
02/25/2016 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-14 ENALAPRIL MALEATE TARO Labeling Approval
02/25/2016 ALENDRONATE SODIUM
ANDA #075871		 SUPPL-2 ALENDRONATE SODIUM CHARTWELL RX Labeling Approval
02/25/2016 ALENDRONATE SODIUM
ANDA #075871		 SUPPL-3 ALENDRONATE SODIUM CHARTWELL RX Labeling Approval
02/25/2016 CICLOPIROX
ANDA #090273		 SUPPL-2 CICLOPIROX GLENMARK PHARMS Labeling Approval
02/25/2016 ETOMIDATE
ANDA #202354		 ORIG-1 ETOMIDATE HIKMA Approval
02/25/2016 TRANEXAMIC ACID
ANDA #202755		 ORIG-1 TRANEXAMIC ACID CHARTWELL RX Approval
02/25/2016 FINASTERIDE
ANDA #203687		 SUPPL-4 FINASTERIDE AUROBINDO PHARMA LTD Labeling Approval
02/25/2016 DESOXIMETASONE
ANDA #208101		 ORIG-1 DESOXIMETASONE PAI HOLDINGS PHARM Approval
02/26/2016 LITHIUM CARBONATE
NDA #017812		 SUPPL-30 LITHIUM CARBONATE HIKMA Manufacturing (CMC) Approval
02/26/2016 HUMULIN R
BLA #018780		 SUPPL-154 INSULIN HUMAN LILLY Approval
02/26/2016 HUMULIN R
BLA #018780		 SUPPL-154 INSULIN RECOMBINANT HUMAN LILLY Approval
02/26/2016 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-154 INSULIN HUMAN LILLY Approval
02/26/2016 HUMULIN R PEN
BLA #018780		 SUPPL-154 INSULIN RECOMBINANT HUMAN LILLY Approval
02/26/2016 BIO-TROPIN
BLA #019774		 SUPPL-34 SOMATROPIN FERRING Approval
02/26/2016 ZOMACTON
BLA #019774		 SUPPL-34 SOMATROPIN FERRING Approval
02/26/2016 MESNEX
NDA #019884		 SUPPL-15 MESNA BAXTER HLTHCARE Manufacturing (CMC) Approval
02/26/2016 NUTROPIN AQ
BLA #020522		 SUPPL-57 SOMATROPIN GENENTECH Approval
02/26/2016 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-57 SOMATROPIN GENENTECH Approval
02/26/2016 NUTROPIN AQ PEN
BLA #020522		 SUPPL-57 SOMATROPIN GENENTECH Approval
02/26/2016 INVIRASE
NDA #020628		 SUPPL-41 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Labeling Approval
02/26/2016 INVIRASE
NDA #021785		 SUPPL-17 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
02/26/2016 VIMPAT
NDA #022255		 SUPPL-17 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
02/26/2016 AFINITOR
NDA #022334		 SUPPL-36 EVEROLIMUS NOVARTIS Efficacy Approval
02/26/2016 PYLERA
NDA #050786		 SUPPL-14 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Manufacturing (CMC) Approval
02/26/2016 OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
NDA #050824		 SUPPL-5 AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE CUMBERLAND Manufacturing (CMC) Approval
02/26/2016 ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ANDA #075794		 SUPPL-45 ACETAMINOPHEN; ASPIRIN; CAFFEINE PERRIGO Manufacturing (CMC) Approval
02/26/2016 ZONISAMIDE
ANDA #077869		 SUPPL-7 ZONISAMIDE INVAGEN PHARMS Labeling Approval
02/26/2016 ESOMEPRAZOLE MAGNESIUM
ANDA #078279		 SUPPL-2 ESOMEPRAZOLE MAGNESIUM DR REDDYS Manufacturing (CMC) Approval
02/26/2016 TOPOTECAN HYDROCHLORIDE
ANDA #091089		 SUPPL-2 TOPOTECAN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/26/2016 TOPOTECAN HYDROCHLORIDE
ANDA #091089		 SUPPL-4 TOPOTECAN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
02/26/2016 CIMZIA
BLA #125160		 SUPPL-266 CERTOLIZUMAB PEGOL UCB INC Approval
02/26/2016 GAZYVA
BLA #125486		 SUPPL-13 OBINUTUZUMAB GENENTECH Approval
02/26/2016 TESTOSTERONE
NDA #203098		 SUPPL-7 TESTOSTERONE PERRIGO ISRAEL Manufacturing (CMC) Approval
02/26/2016 FLUDEOXYGLUCOSE F18
ANDA #204333		 SUPPL-2 FLUDEOXYGLUCOSE F-18 MA GENERAL HOSP Labeling Approval
02/26/2016 NICOTINE POLACRILEX
ANDA #204833		 ORIG-1 NICOTINE POLACRILEX P AND L Approval
02/26/2016 OLYSIO
NDA #205123		 SUPPL-10 SIMEPREVIR SODIUM JANSSEN PRODS Efficacy Approval
02/28/2016 ONDANSETRON
ANDA #077557		 SUPPL-10 ONDANSETRON SUN PHARM INDS Labeling Approval
02/28/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #078171		 SUPPL-1 LEVALBUTEROL HYDROCHLORIDE CIPLA Labeling Approval
02/28/2016 LEVALBUTEROL HYDROCHLORIDE
ANDA #078171		 SUPPL-3 LEVALBUTEROL HYDROCHLORIDE CIPLA Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-14 DIVALPROEX SODIUM ENDO OPERATIONS Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-15 DIVALPROEX SODIUM ENDO OPERATIONS Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-16 DIVALPROEX SODIUM ENDO OPERATIONS Labeling Approval
02/28/2016 RAMIPRIL
ANDA #078745		 SUPPL-8 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
02/28/2016 RAMIPRIL
ANDA #078745		 SUPPL-9 RAMIPRIL CHARTWELL MOLECULAR Labeling Approval
02/28/2016 RISEDRONATE SODIUM
ANDA #079215		 SUPPL-2 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-5 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-6 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-7 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-8 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/28/2016 DIVALPROEX SODIUM
ANDA #090161		 SUPPL-10 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
02/28/2016 COLISTIMETHATE SODIUM
ANDA #201365		 SUPPL-2 COLISTIMETHATE SODIUM SAGENT PHARMS INC Labeling Approval
02/29/2016 MAGNESIUM SULFATE
NDA #019316		 SUPPL-20 MAGNESIUM SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
02/29/2016 GONAL-F
BLA #020378		 SUPPL-58 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/29/2016 EFFEXOR XR
NDA #020699		 SUPPL-106 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
02/29/2016 VANIQA
NDA #021145		 SUPPL-10 EFLORNITHINE HYDROCHLORIDE SKINMEDICA Manufacturing (CMC) Approval
02/29/2016 ELIGARD KIT
NDA #021343		 SUPPL-33 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/29/2016 ELIGARD KIT
NDA #021379		 SUPPL-33 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/29/2016 ELIGARD KIT
NDA #021488		 SUPPL-30 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/29/2016 DEPO-SUBQ PROVERA 104
NDA #021583		 SUPPL-13 MEDROXYPROGESTERONE ACETATE PFIZER Manufacturing (CMC) Approval
02/29/2016 ELIGARD KIT
NDA #021731		 SUPPL-29 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/29/2016 ANCEF IN PLASTIC CONTAINER
ANDA #063002		 SUPPL-15 CEFAZOLIN SODIUM BAXTER HLTHCARE Labeling Approval
02/29/2016 FENOPROFEN CALCIUM
ANDA #072602		 SUPPL-8 FENOPROFEN CALCIUM WATSON LABS Labeling Approval
02/29/2016 BUSPIRONE HYDROCHLORIDE
ANDA #075521		 SUPPL-5 BUSPIRONE HYDROCHLORIDE RUBICON Labeling Approval
02/29/2016 MEGESTROL ACETATE
ANDA #075997		 SUPPL-14 MEGESTROL ACETATE HIKMA Labeling Approval
02/29/2016 ANAGRELIDE HYDROCHLORIDE
ANDA #076468		 SUPPL-16 ANAGRELIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
02/29/2016 GLIMEPIRIDE
ANDA #076802		 SUPPL-16 GLIMEPIRIDE TEVA Labeling Approval
02/29/2016 GLIMEPIRIDE
ANDA #076802		 SUPPL-17 GLIMEPIRIDE TEVA Labeling Approval
02/29/2016 LEFLUNOMIDE
ANDA #077090		 SUPPL-9 LEFLUNOMIDE APOTEX INC Labeling Approval
02/29/2016 LEFLUNOMIDE
ANDA #077090		 SUPPL-11 LEFLUNOMIDE APOTEX INC Labeling Approval
02/29/2016 BETAMETHASONE DIPROPIONATE
ANDA #077111		 SUPPL-4 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
02/29/2016 MEGESTROL ACETATE
ANDA #077404		 SUPPL-7 MEGESTROL ACETATE NOVITIUM PHARMA Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-2 CLOPIDOGREL BISULFATE RISING Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-3 CLOPIDOGREL BISULFATE RISING Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-5 CLOPIDOGREL BISULFATE RISING Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-6 CLOPIDOGREL BISULFATE RISING Labeling Approval
02/29/2016 RISPERIDONE
ANDA #078744		 SUPPL-2 RISPERIDONE WOCKHARDT Labeling Approval
02/29/2016 RISPERIDONE
ANDA #078744		 SUPPL-3 RISPERIDONE WOCKHARDT Labeling Approval
02/29/2016 GABAPENTIN
ANDA #078782		 SUPPL-3 GABAPENTIN HIKMA PHARMS Labeling Approval
02/29/2016 GABAPENTIN
ANDA #078782		 SUPPL-5 GABAPENTIN HIKMA PHARMS Labeling Approval
02/29/2016 GABAPENTIN
ANDA #078782		 SUPPL-6 GABAPENTIN HIKMA PHARMS Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #090844		 SUPPL-3 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #090844		 SUPPL-4 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #090844		 SUPPL-5 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
02/29/2016 CLOPIDOGREL BISULFATE
ANDA #090844		 SUPPL-6 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
02/29/2016 MEROPENEM
ANDA #091201		 SUPPL-5 MEROPENEM SANDOZ Labeling Approval
02/29/2016 MEROPENEM
ANDA #091201		 SUPPL-8 MEROPENEM SANDOZ Labeling Approval
02/29/2016 GLIMEPIRIDE
ANDA #202759		 SUPPL-4 GLIMEPIRIDE AUROBINDO PHARMA LTD Labeling Approval
02/29/2016 QNASL
NDA #202813		 SUPPL-10 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
02/29/2016 CLARITHROMYCIN
ANDA #203243		 ORIG-1 CLARITHROMYCIN NOSTRUM LABS INC Approval
02/29/2016 TECFIDERA
NDA #204063		 SUPPL-14 DIMETHYL FUMARATE BIOGEN INC Labeling Approval
02/29/2016 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204772		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Approval
02/29/2016 ACYCLOVIR SODIUM
ANDA #205771		 ORIG-1 ACYCLOVIR SODIUM HIKMA Approval
02/29/2016 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #206748		 ORIG-1 GLYBURIDE; METFORMIN HYDROCHLORIDE ZYDUS PHARMS Approval
02/29/2016 OXYBUTYNIN CHLORIDE
ANDA #207138		 ORIG-1 OXYBUTYNIN CHLORIDE ACCORD HLTHCARE Approval
02/29/2016 ACETYLCYSTEINE
ANDA #207358		 ORIG-1 ACETYLCYSTEINE EUGIA PHARMA Approval
02/29/2016 TETRACAINE HYDROCHLORIDE
NDA #208135		 ORIG-1 TETRACAINE HYDROCHLORIDE ALCON LABS Type 7 - Drug Already Marketed without Approved NDA Approval
02/29/2016 FLUTICASONE PROPIONATE
ANDA #208150		 ORIG-1 FLUTICASONE PROPIONATE APOTEX Approval
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