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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2019

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 May 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/2019 KUVAN
NDA #022181		 SUPPL-17 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Labeling Approval
02/01/2019 AZITHROMYCIN
ANDA #065209		 SUPPL-25 AZITHROMYCIN SANDOZ Labeling Approval
02/01/2019 AZITHROMYCIN
ANDA #065209		 SUPPL-26 AZITHROMYCIN SANDOZ Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-4 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-7 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-9 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-11 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
02/01/2019 OPDIVO
BLA #125554		 SUPPL-72 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
02/01/2019 XARELTO
NDA #202439		 SUPPL-29 RIVAROXABAN JANSSEN PHARMS Labeling Approval
02/01/2019 OPSUMIT
NDA #204410		 SUPPL-18 MACITENTAN ACTELION REMS Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #205761		 SUPPL-2 RABEPRAZOLE SODIUM AUROBINDO PHARMA Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #205761		 SUPPL-3 RABEPRAZOLE SODIUM AUROBINDO PHARMA Labeling Approval
02/01/2019 DICYCLOMINE HYDROCHLORIDE
ANDA #206468		 ORIG-1 DICYCLOMINE HYDROCHLORIDE NEXUS Approval
02/01/2019 OXYCODONE HYDROCHLORIDE
ANDA #206914		 ORIG-1 OXYCODONE HYDROCHLORIDE PHARM ASSOC Approval
02/01/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-2 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
02/01/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-3 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
02/01/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208737		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE CEDIPROF INC Approval
02/01/2019 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #210787		 ORIG-1 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE LAURUS LABS LTD Type 4 - New Combination Tentative Approval
02/01/2019 BACLOFEN
ANDA #211555		 ORIG-1 BACLOFEN EYWA PHARMA Approval
02/01/2019 JEUVEAU
BLA #761085		 ORIG-1 PRABOTULINUMTOXINA-XVFS EVOLUS INC Approval
02/02/2019 METFORMIN HYDROCHLORIDE
ANDA #076033		 SUPPL-16 METFORMIN HYDROCHLORIDE ATLAS PHARMS LLC Labeling Approval
02/02/2019 METFORMIN HYDROCHLORIDE
ANDA #076033		 SUPPL-20 METFORMIN HYDROCHLORIDE ATLAS PHARMS LLC Labeling Approval
02/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090362		 SUPPL-7 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM Labeling Approval
02/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090362		 SUPPL-8 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM Labeling Approval
02/02/2019 METFORMIN HYDROCHLORIDE
ANDA #091184		 SUPPL-10 METFORMIN HYDROCHLORIDE ALKEM Labeling Approval
02/02/2019 METFORMIN HYDROCHLORIDE
ANDA #091184		 SUPPL-12 METFORMIN HYDROCHLORIDE ALKEM Labeling Approval
02/02/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-17 HYDROCHLOROTHIAZIDE; IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
02/02/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-24 HYDROCHLOROTHIAZIDE; IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
02/02/2019 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-17 IRBESARTAN: HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Labeling Approval
02/02/2019 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-24 IRBESARTAN: HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Labeling Approval
02/04/2019 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-18 FENOFIBRATE LUPIN Manufacturing (CMC) Approval
02/04/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089673		 SUPPL-27 ACETAMINOPHEN; CODEINE PHOSPHATE RHODES PHARMS REMS Approval
02/04/2019 POTASSIUM CHLORIDE
NDA #206814		 SUPPL-7 POTASSIUM CHLORIDE GENUS LIFESCIENCES Labeling Approval
02/04/2019 LABETALOL HYDROCHLORIDE
ANDA #207863		 ORIG-1 LABETALOL HYDROCHLORIDE EYWA Approval
02/04/2019 VEMLIDY
NDA #208464		 SUPPL-7 TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
02/04/2019 ACYCLOVIR
ANDA #208702		 ORIG-1 ACYCLOVIR PADAGIS ISRAEL Approval
02/04/2019 XEPI
NDA #208945		 SUPPL-1 OZENOXACIN FERRER INTERNACIONAL Labeling Approval
02/04/2019 LEVOMILNACIPRAN HYDROCHLORIDE
ANDA #210790		 ORIG-1 LEVOMILNACIPRAN HYDROCHLORIDE AMNEAL PHARMS CO Approval
02/04/2019 DAPAGLIFLOZIN
ANDA #211541		 ORIG-1 DAPAGLIFLOZIN TEVA PHARMS USA INC Tentative Approval
02/04/2019 OXYCODONE HYDROCHLORIDE
ANDA #211749		 ORIG-1 OXYCODONE HYDROCHLORIDE ALKEM LABS LTD Approval
02/05/2019 AVANDIA
NDA #021071		 SUPPL-52 ROSIGLITAZONE MALEATE WOODWARD Labeling Approval
02/05/2019 LEVOFLOXACIN
ANDA #204968		 ORIG-1 LEVOFLOXACIN HEC PHARM Approval
02/05/2019 TADALAFIL
ANDA #206286		 ORIG-1 TADALAFIL AUROBINDO PHARMA LTD Approval
02/05/2019 DYANAVEL XR
NDA #208147		 SUPPL-5 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Efficacy Approval
02/05/2019 TADALAFIL
ANDA #209907		 ORIG-1 TADALAFIL HETERO LABS LTD III Approval
02/05/2019 ALYQ
ANDA #209942		 ORIG-1 TADALAFIL TEVA PHARMS USA Approval
02/05/2019 TADALAFIL
ANDA #210145		 ORIG-1 TADALAFIL DR REDDYS Approval
02/05/2019 TADALAFIL
ANDA #210255		 ORIG-1 TADALAFIL CIPLA Approval
02/05/2019 TADALAFIL
ANDA #210392		 ORIG-1 TADALAFIL AJANTA PHARMA LTD Approval
02/05/2019 TADALAFIL
ANDA #210572		 ORIG-1 TADALAFIL CHARTWELL RX Approval
02/05/2019 ESTRADIOL
ANDA #211293		 ORIG-1 ESTRADIOL AMNEAL Approval
02/06/2019 BUTISOL SODIUM
NDA #000793		 SUPPL-26 BUTABARBITAL SODIUM MYLAN SPECIALITY LP Labeling Approval
02/06/2019 HALCION
NDA #017892		 SUPPL-54 TRIAZOLAM PFIZER Labeling Approval
02/06/2019 RESTORIL
NDA #018163		 SUPPL-65 TEMAZEPAM SPECGX LLC Labeling Approval
02/06/2019 DORAL
NDA #018708		 SUPPL-25 QUAZEPAM GALT PHARMS Labeling Approval
02/06/2019 CLARITIN
NDA #019658		 SUPPL-56 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/06/2019 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-56 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/06/2019 AMBIEN
NDA #019908		 SUPPL-45 ZOLPIDEM TARTRATE SANOFI AVENTIS US Labeling Approval
02/06/2019 SONATA
NDA #020859		 SUPPL-15 ZALEPLON PFIZER Labeling Approval
02/06/2019 LUNESTA
NDA #021476		 SUPPL-37 ESZOPICLONE WAYLIS THERAP Labeling Approval
02/06/2019 AMBIEN CR
NDA #021774		 SUPPL-26 ZOLPIDEM TARTRATE SANOFI AVENTIS US Labeling Approval
02/06/2019 EDLUAR
NDA #021997		 SUPPL-10 ZOLPIDEM TARTRATE MYLAN SPECIALITY LP Labeling Approval
02/06/2019 ZOLPIMIST
NDA #022196		 SUPPL-11 ZOLPIDEM TARTRATE AYTU Labeling Approval
02/06/2019 INTERMEZZO
NDA #022328		 SUPPL-7 ZOLPIDEM TARTRATE PURDUE PHARMA Labeling Approval
02/06/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #070345		 SUPPL-20 FLURAZEPAM HYDROCHLORIDE RISING Labeling Approval
02/06/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #070454		 SUPPL-19 FLURAZEPAM HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
02/06/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #070455		 SUPPL-19 FLURAZEPAM HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
02/06/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #072368		 SUPPL-6 FLURAZEPAM HYDROCHLORIDE CHARTWELL RX Labeling Approval
02/06/2019 ESTAZOLAM
ANDA #074826		 SUPPL-18 ESTAZOLAM NOVITIUM PHARMA Labeling Approval
02/06/2019 ESTAZOLAM
ANDA #074921		 SUPPL-16 ESTAZOLAM DR REDDYS LABS SA Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #083245		 SUPPL-14 PENTOBARBITAL SODIUM EPIC PHARMA LLC Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #084093		 SUPPL-12 PENTOBARBITAL SODIUM EPIC PHARMA LLC Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #084095		 SUPPL-8 PENTOBARBITAL SODIUM EPIC PHARMA LLC Labeling Approval
02/06/2019 SODIUM BUTABARBITAL
ANDA #085849		 SUPPL-6 BUTABARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 SODIUM BUTABARBITAL
ANDA #085866		 SUPPL-7 BUTABARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 BUTALAN
ANDA #085880		 SUPPL-1 BUTABARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 SODIUM BUTABARBITAL
ANDA #085881		 SUPPL-5 BUTABARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 PENTOBARBITAL SODIUM
ANDA #085915		 SUPPL-3 PENTOBARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 PENTOBARBITAL SODIUM
ANDA #085937		 SUPPL-3 PENTOBARBITAL SODIUM LANNETT Labeling Approval
02/06/2019 SYLEVIA
ANDA #202988		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL SUN PHARM Approval
02/06/2019 STRIBILD
NDA #203100		 SUPPL-34 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
02/06/2019 NALBUPHINE HYDROCHLORIDE
ANDA #206506		 ORIG-1 NALBUPHINE HYDROCHLORIDE RISING Approval
02/06/2019 OXYBUTYNIN CHLORIDE
ANDA #211062		 ORIG-1 OXYBUTYNIN CHLORIDE EYWA Approval
02/06/2019 CABLIVI
BLA #761112		 ORIG-1 CAPLACIZUMAB-YHDP ABLYNX NV Approval
02/07/2019 DIFLUCAN
NDA #019949		 SUPPL-65 FLUCONAZOLE PFIZER Labeling Approval
02/07/2019 DIFLUCAN
NDA #020090		 SUPPL-47 FLUCONAZOLE PFIZER Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-4 RABEPRAZOLE SODIUM MYLAN Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-5 RABEPRAZOLE SODIUM MYLAN Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-6 RABEPRAZOLE SODIUM MYLAN Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885		 SUPPL-8 RABEPRAZOLE SODIUM MYLAN Labeling Approval
02/07/2019 BICALUTAMIDE
ANDA #078634		 SUPPL-6 BICALUTAMIDE WATSON LABS TEVA Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-5 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-6 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-7 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #090678		 SUPPL-10 RABEPRAZOLE SODIUM LANNETT CO INC Labeling Approval
02/07/2019 CARBAMAZEPINE
ANDA #205571		 ORIG-1 CARBAMAZEPINE ZYDUS PHARMS Approval
02/07/2019 NICOTINE POLACRILEX
ANDA #207868		 ORIG-1 NICOTINE POLACRILEX PLD ACQUISITIONS Approval
02/07/2019 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
ANDA #209281		 ORIG-1 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL ACCORD HLTHCARE Approval
02/07/2019 ESKATA
NDA #209305		 SUPPL-1 HYDROGEN PEROXIDE ACLARIS Labeling Approval
02/07/2019 OXYCODONE HYDROCHLORIDE
ANDA #211748		 ORIG-1 OXYCODONE HYDROCHLORIDE ALKEM LABS LTD Approval
02/08/2019 CANCIDAS
NDA #021227		 SUPPL-39 CASPOFUNGIN ACETATE MERCK Labeling Approval
02/08/2019 DOXYCYCLINE
ANDA #203278		 ORIG-1 DOXYCYCLINE AMNEAL PHARMS Tentative Approval
02/08/2019 SEVELAMER HYDROCHLORIDE
ANDA #204724		 ORIG-1 SEVELAMER HYDROCHLORIDE GLENMARK PHARMS LTD Approval
02/08/2019 IMATINIB MESYLATE
ANDA #205990		 ORIG-1 IMATINIB MESYLATE BRECKENRIDGE Approval
02/08/2019 IMATINIB MESYLATE
ANDA #207495		 ORIG-1 IMATINIB MESYLATE AMNEAL PHARMS Approval
02/08/2019 DEFERIPRONE
ANDA #208800		 ORIG-1 DEFERIPRONE TARO Approval
02/08/2019 TRIENTINE HYDROCHLORIDE
ANDA #210619		 ORIG-1 TRIENTINE HYDROCHLORIDE AMNEAL Approval
02/08/2019 COLCHICINE
ANDA #211250		 ORIG-1 COLCHICINE ALKEM LABS LTD Approval
02/08/2019 FLUOXETINE HYDROCHLORIDE
ANDA #211632		 ORIG-1 FLUOXETINE HYDROCHLORIDE LUPIN LTD Approval
02/08/2019 ATORVASTATIN CALCIUM
ANDA #211933		 ORIG-1 ATORVASTATIN CALCIUM MSN Approval
02/08/2019 DARZALEX
BLA #761036		 SUPPL-16 DARATUMUMAB JANSSEN BIOTECH Approval
02/11/2019 VANTAS
NDA #021732		 SUPPL-22 HISTRELIN ACETATE ENDO PHARM Labeling Approval
02/11/2019 NOVOLOG MIX 50/50
BLA #021810		 SUPPL-15 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/11/2019 CAYSTON
NDA #050814		 SUPPL-21 AZTREONAM GILEAD Labeling Approval
02/11/2019 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #208358		 ORIG-1 HYDROCHLOROTHIAZIDE; TRIAMTERENE CADILA Approval
02/11/2019 LO-MALMOREDE
ANDA #209548		 ORIG-1 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE NOVAST LABS Approval
02/11/2019 FENOFIBRATE
ANDA #209660		 ORIG-1 FENOFIBRATE CHARTWELL RX Approval
02/11/2019 OMEPRAZOLE
ANDA #210070		 ORIG-1 OMEPRAZOLE APOTEX Approval
02/11/2019 TRIAMCINOLONE ACETONIDE
ANDA #210346		 ORIG-1 TRIAMCINOLONE ACETONIDE STRIDES PHARMA Approval
02/11/2019 DICYCLOMINE HYDROCHLORIDE
ANDA #210788		 ORIG-1 DICYCLOMINE HYDROCHLORIDE HIKMA Approval
02/12/2019 ANCOBON
NDA #017001		 SUPPL-33 FLUCYTOSINE BAUSCH Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845		 SUPPL-1 LINEZOLID RISING Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845		 SUPPL-2 LINEZOLID RISING Labeling Approval
02/12/2019 AZACITIDINE
ANDA #204949		 SUPPL-2 AZACITIDINE MYLAN INSTITUTIONAL Labeling Approval
02/12/2019 AZACITIDINE
ANDA #204949		 SUPPL-3 AZACITIDINE MYLAN INSTITUTIONAL Labeling Approval
02/12/2019 MYCOPHENOLATE MOFETIL
ANDA #210370		 ORIG-1 MYCOPHENOLATE MOFETIL VISTAPHARM Approval
02/13/2019 INOMAX
NDA #020845		 SUPPL-20 NITRIC OXIDE MALLINCKRODT HOSP Labeling Approval
02/13/2019 EMBELINE
ANDA #074221		 SUPPL-8 CLOBETASOL PROPIONATE HIKMA Manufacturing (CMC) Approval
02/13/2019 CIMETIDINE HYDROCHLORIDE
ANDA #074664		 SUPPL-2 CIMETIDINE HYDROCHLORIDE PAI HOLDINGS PHARM Manufacturing (CMC) Approval
02/13/2019 OFLOXACIN
ANDA #076513		 SUPPL-21 OFLOXACIN APOTEX INC Manufacturing (CMC) Approval
02/13/2019 EGATEN
NDA #208711		 ORIG-1 TRICLABENDAZOLE NOVARTIS Type 1 - New Molecular Entity Approval
02/13/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #209469		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE ALEMBIC Approval
02/13/2019 FLUOCINOLONE ACETONIDE
ANDA #209913		 ORIG-1 FLUOCINOLONE ACETONIDE ENCUBE ETHICALS Approval
02/13/2019 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935		 SUPPL-2 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
02/14/2019 M.V.I. PEDIATRIC
NDA #018920		 SUPPL-38 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Labeling Approval
02/14/2019 SPIRIVA RESPIMAT
NDA #021936		 SUPPL-12 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
02/14/2019 AZITHROMYCIN
ANDA #065211		 SUPPL-30 AZITHROMYCIN SANDOZ Labeling Approval
02/14/2019 AZITHROMYCIN
ANDA #065212		 SUPPL-28 AZITHROMYCIN SANDOZ Labeling Approval
02/14/2019 METFORMIN HYDROCHLORIDE
ANDA #077095		 SUPPL-23 METFORMIN HYDROCHLORIDE AUROBINDO Labeling Approval
02/14/2019 METFORMIN HYDROCHLORIDE
ANDA #077095		 SUPPL-24 METFORMIN HYDROCHLORIDE AUROBINDO Labeling Approval
02/14/2019 DESMOPRESSIN ACETATE
ANDA #091374		 ORIG-1 DESMOPRESSIN ACETATE AM REGENT Approval
02/14/2019 ENBREL
BLA #103795		 SUPPL-5571 ETANERCEPT IMMUNEX Approval
02/14/2019 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205630		 SUPPL-3 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN LTD Labeling Approval
02/14/2019 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205630		 SUPPL-4 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN LTD Manufacturing (CMC) Approval
02/14/2019 GEMCITABINE HYDROCHLORIDE
ANDA #210383		 ORIG-1 GEMCITABINE HYDROCHLORIDE NOVAST LABS Approval
02/14/2019 IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #210676		 ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN AUROBINDO PHARMA LTD Approval
02/15/2019 ELIGARD KIT
NDA #021343		 SUPPL-39 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/15/2019 ELIGARD KIT
NDA #021379		 SUPPL-41 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/15/2019 ELIGARD KIT
NDA #021488		 SUPPL-36 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/15/2019 ELIGARD KIT
NDA #021731		 SUPPL-37 LEUPROLIDE ACETATE TOLMAR Labeling Approval
02/15/2019 BYDUREON
NDA #022200		 SUPPL-28 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
02/15/2019 BYDUREON PEN
NDA #022200		 SUPPL-28 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
02/15/2019 ONTAK
BLA #103767		 SUPPL-5143 DENILEUKIN DIFTITOX EISAI INC Approval
02/15/2019 KEYTRUDA
BLA #125514		 SUPPL-40 PEMBROLIZUMAB MERCK SHARP DOHME Approval
02/15/2019 REPATHA
BLA #125522		 SUPPL-19 EVOLOCUMAB AMGEN INC Approval
02/15/2019 REPATHA
BLA #125522		 SUPPL-22 EVOLOCUMAB AMGEN INC Approval
02/15/2019 OXALIPLATIN
ANDA #202922		 ORIG-2 OXALIPLATIN SUN PHARM Approval
02/15/2019 PROCHLORPERAZINE EDISYLATE
ANDA #204860		 ORIG-1 PROCHLORPERAZINE EDISYLATE NEXUS Approval
02/15/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #205757		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE PHARMASCIENCE INC Tentative Approval
02/15/2019 RISEDRONATE SODIUM
ANDA #207516		 ORIG-1 RISEDRONATE SODIUM HANGZHOU BINJIANG Approval
02/15/2019 BYDUREON BCISE
NDA #209210		 SUPPL-1 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
02/15/2019 CLOTRIMAZOLE
ANDA #209815		 ORIG-1 CLOTRIMAZOLE NOVITIUM PHARMA Approval
02/15/2019 CLOBETASOL PROPIONATE
ANDA #210809		 ORIG-1 CLOBETASOL PROPIONATE GLENMARK PHARMS LTD Approval
02/15/2019 VANCOMYCIN HYDROCHLORIDE
NDA #211962		 ORIG-1 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Type 5 - New Formulation or New Manufacturer Approval
02/19/2019 GEMFIBROZIL
ANDA #075034		 SUPPL-29 GEMFIBROZIL APOTEX Labeling Approval
02/19/2019 GEMFIBROZIL
ANDA #202726		 SUPPL-6 GEMFIBROZIL AUROBINDO PHARMA LTD Labeling Approval
02/19/2019 IBRANCE
NDA #207103		 SUPPL-10 PALBOCICLIB PFIZER Labeling Approval
02/19/2019 TELMISARTAN
ANDA #207843		 ORIG-1 TELMISARTAN HISUN PHARM HANGZHOU Approval
02/19/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #207896		 SUPPL-2 HYDROCHLOROTHIAZIDE; IRBESARTAN HISUN PHARM HANGZHOU Labeling Approval
02/19/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #207896		 SUPPL-3 HYDROCHLOROTHIAZIDE; IRBESARTAN HISUN PHARM HANGZHOU Labeling Approval
02/19/2019 AZITHROMYCIN
ANDA #209044		 SUPPL-1 AZITHROMYCIN SUNSHINE Manufacturing (CMC) Approval
02/19/2019 AZITHROMYCIN
ANDA #209045		 SUPPL-1 AZITHROMYCIN SUNSHINE Manufacturing (CMC) Approval
02/19/2019 ACETAZOLAMIDE
ANDA #210423		 ORIG-1 ACETAZOLAMIDE ALEMBIC Approval
02/19/2019 LEVOTHYROXINE SODIUM
ANDA #210831		 ORIG-1 LEVOTHYROXINE SODIUM AMNEAL Approval
02/19/2019 BUPIVACAINE HYDROCHLORIDE
ANDA #211096		 ORIG-1 BUPIVACAINE HYDROCHLORIDE CIVICA Approval
02/19/2019 COLCHICINE
ANDA #211519		 ORIG-1 COLCHICINE ZYDUS PHARMS Approval
02/19/2019 ETHOSUXIMIDE
ANDA #211928		 ORIG-1 ETHOSUXIMIDE STRIDES PHARMA Approval
02/20/2019 NAPROXEN SODIUM
NDA #021920		 SUPPL-23 NAPROXEN SODIUM BIONPHARMA Labeling Approval
02/20/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #204771		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE GLENMARK PHARMS LTD Tentative Approval
02/20/2019 ACYCLOVIR
ANDA #205659		 ORIG-1 ACYCLOVIR PADAGIS ISRAEL Approval
02/20/2019 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206791		 ORIG-1 CISATRACURIUM BESYLATE SOMERSET THERAPS LLC Approval
02/20/2019 PHYTONADIONE
ANDA #210189		 ORIG-1 PHYTONADIONE ZYDUS Approval
02/20/2019 DIMETHYL FUMARATE
ANDA #210390		 ORIG-1 DIMETHYL FUMARATE TORRENT PHARMS LLC Tentative Approval
02/21/2019 RINGER'S IN PLASTIC CONTAINER
NDA #016693		 SUPPL-101 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
NDA #018037		 SUPPL-73 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEPAKENE
NDA #018081		 SUPPL-69 VALPROIC ACID ABBVIE Labeling Approval
02/21/2019 DEPAKENE
NDA #018082		 SUPPL-52 VALPROIC ACID ABBVIE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-46 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEPAKOTE
NDA #018723		 SUPPL-61 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-30 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-30 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-30 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-30 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019308		 SUPPL-30 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
02/21/2019 DEPAKOTE
NDA #019680		 SUPPL-48 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/21/2019 DEPACON
NDA #020593		 SUPPL-39 VALPROATE SODIUM ABBVIE Labeling Approval
02/21/2019 DEPAKOTE ER
NDA #021168		 SUPPL-39 DIVALPROEX SODIUM ABBVIE Labeling Approval
02/21/2019 RENAGEL
NDA #021179		 SUPPL-37 SEVELAMER HYDROCHLORIDE GENZYME Labeling Approval
02/21/2019 CIPRODEX
NDA #021537		 SUPPL-17 CIPROFLOXACIN; DEXAMETHASONE SANDOZ Labeling Approval
02/21/2019 ULORIC
NDA #021856		 SUPPL-13 FEBUXOSTAT TAKEDA PHARMS USA Efficacy Approval
02/21/2019 NOXAFIL
NDA #022003		 SUPPL-25 POSACONAZOLE SCHERING Labeling Approval
02/21/2019 DIAZEPAM
ANDA #071583		 SUPPL-23 DIAZEPAM HOSPIRA Labeling Approval
02/21/2019 DIAZEPAM
ANDA #072079		 SUPPL-32 DIAZEPAM HOSPIRA Labeling Approval
02/21/2019 IBUPROFEN
ANDA #078682		 SUPPL-16 IBUPROFEN BIONPHARMA Labeling Approval
02/21/2019 IBUPROFEN
ANDA #078682		 SUPPL-21 IBUPROFEN BIONPHARMA Labeling Approval
02/21/2019 PREDNISONE
ANDA #083677		 SUPPL-60 PREDNISONE MYLAN Manufacturing (CMC) Approval
02/21/2019 TROKENDI XR
NDA #201635		 SUPPL-20 TOPIRAMATE SUPERNUS PHARMS Labeling Approval
02/21/2019 CALCITRIOL
ANDA #204556		 ORIG-1 CALCITRIOL SUN PHARM Approval
02/21/2019 NOXAFIL
NDA #205053		 SUPPL-9 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
02/21/2019 QUDEXY XR
NDA #205122		 SUPPL-8 TOPIRAMATE UPSHER SMITH LABS Labeling Approval
02/21/2019 NOXAFIL
NDA #205596		 SUPPL-8 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
02/21/2019 ARIPIPRAZOLE
ANDA #207105		 ORIG-1 ARIPIPRAZOLE ALKEM LABS LTD Approval
02/21/2019 LUMIFY
NDA #208144		 SUPPL-1 BRIMONIDINE TARTRATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
02/21/2019 EXEMESTANE
ANDA #211031		 ORIG-1 EXEMESTANE BRECKENRIDGE Approval
02/22/2019 CISPLATIN
NDA #018057		 SUPPL-89 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/22/2019 PLATINOL
NDA #018057		 SUPPL-89 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/22/2019 PLATINOL-AQ
NDA #018057		 SUPPL-89 CISPLATIN HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/22/2019 CHLORHEXIDINE GLUCONATE
NDA #020111		 SUPPL-13 CHLORHEXIDINE GLUCONATE BAJAJ Labeling Approval
02/22/2019 LANOXIN
NDA #020405		 SUPPL-15 DIGOXIN CONCORDIA Labeling Approval
02/22/2019 MEPRON
NDA #020500		 SUPPL-17 ATOVAQUONE GLAXOSMITHKLINE LLC Labeling Approval
02/22/2019 CAMPTOSAR
NDA #020571		 SUPPL-50 IRINOTECAN HYDROCHLORIDE PFIZER INC Labeling Approval
02/22/2019 XELODA
NDA #020896		 SUPPL-42 CAPECITABINE CHEPLAPHARM Labeling Approval
02/22/2019 MALARONE
NDA #021078		 SUPPL-23 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
02/22/2019 MALARONE PEDIATRIC
NDA #021078		 SUPPL-23 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
02/22/2019 CHANTIX
NDA #021928		 SUPPL-48 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
02/22/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #071107		 SUPPL-30 FLURAZEPAM HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/22/2019 FLURAZEPAM HYDROCHLORIDE
ANDA #071108		 SUPPL-29 FLURAZEPAM HYDROCHLORIDE HIKMA Labeling Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #075978		 SUPPL-33 METFORMIN HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #075978		 SUPPL-34 METFORMIN HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #090406		 SUPPL-6 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MYLAN Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #090406		 SUPPL-7 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MYLAN Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #090406		 SUPPL-8 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MYLAN Labeling Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #090564		 SUPPL-15 METFORMIN HYDROCHLORIDE GRANULES INDIA Labeling Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #090888		 SUPPL-4 METFORMIN HYDROCHLORIDE MARKSANS PHARMA Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091155		 SUPPL-5 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091155		 SUPPL-6 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #200823		 SUPPL-7 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #200823		 SUPPL-9 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
02/22/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #200823		 SUPPL-10 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
02/22/2019 EXEMESTANE
ANDA #200898		 SUPPL-6 EXEMESTANE ALVOGEN Labeling Approval
02/22/2019 EXEMESTANE
ANDA #200898		 SUPPL-10 EXEMESTANE ALVOGEN Labeling Approval
02/22/2019 FARXIGA
NDA #202293		 SUPPL-15 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
02/22/2019 EXEMESTANE
ANDA #203315		 SUPPL-2 EXEMESTANE RISING Labeling Approval
02/22/2019 NIACIN
ANDA #203742		 ORIG-1 NIACIN RISING Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #203769		 SUPPL-9 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
02/22/2019 METFORMIN HYDROCHLORIDE
ANDA #203769		 SUPPL-12 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
02/22/2019 MECLIZINE HYDROCHLORIDE
ANDA #205136		 ORIG-1 MECLIZINE HYDROCHLORIDE WILSHIRE PHARMS INC Approval
02/22/2019 XIGDUO XR
NDA #205649		 SUPPL-9 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
02/22/2019 GLYBURIDE
ANDA #206483		 ORIG-1 GLYBURIDE ORIENT PHARMA CO LTD Approval
02/22/2019 GEMCITABINE HYDROCHLORIDE
ANDA #207575		 ORIG-1 GEMCITABINE HYDROCHLORIDE SHILPA Approval
02/22/2019 LONSURF
NDA #207981		 SUPPL-8 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Efficacy Approval
02/22/2019 LOTEMAX SM
NDA #208219		 ORIG-1 LOTEPREDNOL ETABONATE BAUSCH AND LOMB INC Type 5 - New Formulation or New Manufacturer Approval
02/22/2019 METHYLPREDNISOLONE
ANDA #209097		 ORIG-1 METHYLPREDNISOLONE CHARTWELL RX Approval
02/22/2019 EXEMESTANE
ANDA #209208		 SUPPL-2 EXEMESTANE UPSHER SMITH LABS Labeling Approval
02/22/2019 BUSULFAN
ANDA #210148		 ORIG-1 BUSULFAN ACCORD HLTHCARE INC Approval
02/22/2019 APIXABAN
ANDA #210171		 ORIG-1 APIXABAN SUN PHARM INDUSTRIES Tentative Approval
02/22/2019 EXEMESTANE
ANDA #210323		 SUPPL-1 EXEMESTANE CIPLA Labeling Approval
02/22/2019 OLMESARTAN MEDOXOMIL
ANDA #211049		 ORIG-1 OLMESARTAN MEDOXOMIL SUNSHINE Approval
02/22/2019 BENZONATATE
ANDA #211518		 ORIG-1 BENZONATATE ASCENT PHARMS INC Approval
02/22/2019 CLOFARABINE
ANDA #212034		 ORIG-1 CLOFARABINE ACCORD HLTHCARE Approval
02/25/2019 ANDROGEL
NDA #021015		 SUPPL-44 TESTOSTERONE BESINS HLTHCARE Labeling Approval
02/25/2019 PROAIR HFA
NDA #021457		 SUPPL-36 ALBUTEROL SULFATE TEVA BRANDED PHARM Labeling Approval
02/25/2019 ANDROGEL
NDA #022309		 SUPPL-18 TESTOSTERONE BESINS HLTHCARE Labeling Approval
02/25/2019 PROTOPIC
NDA #050777		 SUPPL-21 TACROLIMUS LEO PHARMA AS Manufacturing (CMC) Approval
02/25/2019 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #206191		 ORIG-1 METRONIDAZOLE INFORLIFE Approval
02/25/2019 OMEGA-3-ACID ETHYL ESTERS
ANDA #207420		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS ASCENT PHARMS INC Approval
02/25/2019 ABIRATERONE ACETATE
ANDA #208371		 ORIG-1 ABIRATERONE ACETATE RISING Approval
02/25/2019 SYMTUZA
NDA #210455		 SUPPL-5 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Labeling Approval
02/26/2019 METFORMIN HYDROCHLORIDE
ANDA #076172		 SUPPL-25 METFORMIN HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
02/26/2019 METFORMIN HYDROCHLORIDE
ANDA #076172		 SUPPL-27 METFORMIN HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
02/26/2019 METFORMIN HYDROCHLORIDE
ANDA #076869		 SUPPL-24 METFORMIN HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
02/26/2019 METFORMIN HYDROCHLORIDE
ANDA #076869		 SUPPL-26 METFORMIN HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
02/26/2019 CINVANTI
NDA #209296		 SUPPL-3 APREPITANT HERON THERAPS INC Efficacy Approval
02/26/2019 AZITHROMYCIN
ANDA #210000		 ORIG-1 AZITHROMYCIN BIONPHARMA Approval
02/26/2019 AZITHROMYCIN
ANDA #210001		 ORIG-1 AZITHROMYCIN BIONPHARMA Approval
02/26/2019 HYDROXYZINE HYDROCHLORIDE
ANDA #210634		 ORIG-1 HYDROXYZINE HYDROCHLORIDE APOZEAL PHARMS Approval
02/26/2019 CHLORTHALIDONE
ANDA #211063		 ORIG-1 CHLORTHALIDONE CHARTWELL RX Approval
02/27/2019 CELLCEPT
NDA #050722		 SUPPL-38 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
02/27/2019 CELLCEPT
NDA #050723		 SUPPL-38 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
02/27/2019 CELLCEPT
NDA #050758		 SUPPL-35 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
02/27/2019 CELLCEPT
NDA #050759		 SUPPL-43 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
02/27/2019 DANTROLENE SODIUM
ANDA #076686		 SUPPL-4 DANTROLENE SODIUM ELITE LABS INC Manufacturing (CMC) Approval
02/27/2019 CIMZIA
BLA #125160		 SUPPL-289 CERTOLIZUMAB PEGOL UCB INC Approval
02/27/2019 ESOMEPRAZOLE MAGNESIUM;NAPROXEN
ANDA #202767		 ORIG-1 ESOMEPRAZOLE MAGNESIUM;NAPROXEN ANCHEN PHARMS Tentative Approval
02/27/2019 LEVOFLOXACIN
ANDA #205600		 ORIG-1 LEVOFLOXACIN MICRO LABS LTD INDIA Approval
02/27/2019 ABIRATERONE ACETATE
ANDA #208380		 ORIG-1 ABIRATERONE ACETATE WOCKHARDT BIO AG Approval
02/27/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-8 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
02/27/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-10 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
02/27/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-11 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
02/27/2019 SOLIQUA 100/33
BLA #208673		 SUPPL-7 INSULIN GLARGINE; LIXISENATIDE SANOFI-AVENTIS US Approval
02/27/2019 AZACITIDINE
ANDA #210748		 ORIG-1 AZACITIDINE LUPIN LTD Approval
02/27/2019 OSELTAMIVIR PHOSPHATE
ANDA #211125		 ORIG-1 OSELTAMIVIR PHOSPHATE TEVA PHARMS USA Approval
02/27/2019 ADHANSIA XR
NDA #212038		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE PURDUE PHARMA LP Type 3 - New Dosage Form Approval
02/28/2019 CLARITIN
NDA #020641		 SUPPL-46 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/28/2019 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-46 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/28/2019 CLARITIN HIVES RELIEF REDITAB
NDA #020704		 SUPPL-34 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/28/2019 CLARITIN REDITABS
NDA #020704		 SUPPL-34 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/28/2019 CLARITIN REDITABS
NDA #021993		 SUPPL-17 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/28/2019 METOZOLV ODT
NDA #022246		 SUPPL-9 METOCLOPRAMIDE HYDROCHLORIDE SALIX PHARMS Labeling Approval
02/28/2019 RIFADIN
NDA #050420		 SUPPL-80 RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/28/2019 RIFADIN
NDA #050627		 SUPPL-23 RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/28/2019 RIFATER
NDA #050705		 SUPPL-15 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
02/28/2019 TERBINAFINE HYDROCHLORIDE
ANDA #077511		 SUPPL-15 TERBINAFINE HYDROCHLORIDE TARO Labeling Approval
02/28/2019 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078316		 SUPPL-7 IBUPROFEN; OXYCODONE HYDROCHLORIDE BARR LABS INC Labeling Approval
02/28/2019 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490		 SUPPL-3 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Labeling Approval
02/28/2019 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490		 SUPPL-4 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Labeling Approval
02/28/2019 KYPROLIS
NDA #202714		 SUPPL-25 CARFILZOMIB ONYX PHARMS AMGEN Labeling Approval
02/28/2019 OXYBUTYNIN CHLORIDE
ANDA #211655		 ORIG-1 OXYBUTYNIN CHLORIDE AJANTA PHARMA LTD Approval
02/28/2019 HERCEPTIN HYLECTA
BLA #761106		 ORIG-1 TRASTUZUMAB; HYALURONIDASE-OYSK GENENTECH INC Approval
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