Drugs@FDA: FDA Approved Drug Products

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All Approvals
February 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on August 22, 2019.

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 LUPIN LTD Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964
SUPPL-7 RABEPRAZOLE SODIUM LUPIN LTD Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964
SUPPL-9 RABEPRAZOLE SODIUM LUPIN LTD Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #078964
SUPPL-11 RABEPRAZOLE SODIUM LUPIN LTD 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 PHARMS LTD REMS Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #205761
SUPPL-2 RABEPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/01/2019 RABEPRAZOLE SODIUM
ANDA #205761
SUPPL-3 RABEPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
02/01/2019 DICYCLOMINE HYDROCHLORIDE
ANDA #206468
ORIG-1 DICYCLOMINE HYDROCHLORIDE NEXUS PHARMS Approval
02/01/2019 OXYCODONE HYDROCHLORIDE
ANDA #206914
ORIG-1 OXYCODONE HYDROCHLORIDE PHARM ASSOC Approval
02/01/2019 XULTOPHY 100/3.6
NDA #208583
SUPPL-2 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
02/01/2019 XULTOPHY 100/3.6
NDA #208583
SUPPL-3 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
02/01/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208737
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE CEDIPROF INC Approval
02/01/2019 APIXABAN
ANDA #210013
ORIG-1 APIXABAN MICRO LABS LTD Tentative 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 ATLANTIS 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 INVATECH PHARMA 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 PERRIGO UK FINCO 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
02/04/2019 FEBUXOSTAT
ANDA #211837
ORIG-1 FEBUXOSTAT TORRENT PHARMS LTD Tentative Approval
02/05/2019 AVANDIA
NDA #021071
SUPPL-52 ROSIGLITAZONE MALEATE SB PHARMCO 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 FULVESTRANT
ANDA #207754
ORIG-1 FULVESTRANT GLENMARK PHARMS INC Tentative Approval
02/05/2019 DYANAVEL XR
NDA #208147
SUPPL-5 AMPHETAMINE 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 LABS LTD 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 LUPIN LTD Approval
02/05/2019 ESTRADIOL
ANDA #211293
ORIG-1 ESTRADIOL AMNEAL PHARMS LLC 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 PHARMACIA AND UPJOHN 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 SUNOVION PHARMS INC 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 MYLAN PHARMS INC 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 HERITAGE PHARMA Labeling Approval
02/06/2019 ESTAZOLAM
ANDA #074826
SUPPL-18 ESTAZOLAM PAR PHARM Labeling Approval
02/06/2019 ESTAZOLAM
ANDA #074921
SUPPL-16 ESTAZOLAM MAYNE PHARMA Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #083245
SUPPL-14 PENTOBARBITAL SODIUM OAK PHARMS Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #084093
SUPPL-12 PENTOBARBITAL SODIUM OAK PHARMS Labeling Approval
02/06/2019 NEMBUTAL SODIUM
ANDA #084095
SUPPL-8 PENTOBARBITAL SODIUM OAK PHARMS 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 MYLAN LABS LTD Approval
02/06/2019 OXYBUTYNIN CHLORIDE
ANDA #211062
ORIG-1 OXYBUTYNIN CHLORIDE INVATECH PHARMA 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 AVONEX
BLA #103628
SUPPL-5263 INTERFERON BETA-1A BIOGEN 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 FINGOLIMOD
ANDA #207983
ORIG-1 FINGOLIMOD AUROBINDO PHARMA LTD Tentative 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 PHARM 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 PHARM INDS LTD Approval
02/08/2019 APIXABAN
ANDA #209944
ORIG-1 APIXABAN SUNSHINE LAKE Tentative Approval
02/08/2019 TRIENTINE HYDROCHLORIDE
ANDA #210619
ORIG-1 TRIENTINE HYDROCHLORIDE AMNEAL PHARMS LLC Approval
02/08/2019 COLCHICINE
ANDA #211250
ORIG-1 COLCHICINE ALKEM LABS LTD Approval
02/08/2019 ESTRADIOL
ANDA #211396
ORIG-1 ESTRADIOL AMNEAL PHARMS Tentative 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 LABS PVT LTD 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
NDA #021810
SUPPL-15 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Labeling 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 ZYDUS PHARMS 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 ORIT LABS LLC Approval
02/11/2019 OMEPRAZOLE
ANDA #210070
ORIG-1 OMEPRAZOLE APOTEX INC 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 CUSTOPHARM INC Approval
02/12/2019 ANCOBON
NDA #017001
SUPPL-33 FLUCYTOSINE BAUSCH Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845
SUPPL-1 LINEZOLID MYLAN Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845
SUPPL-2 LINEZOLID MYLAN 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 HI TECH PHARMA Manufacturing (CMC) Approval
02/13/2019 CIMETIDINE HYDROCHLORIDE
ANDA #074664
SUPPL-2 CIMETIDINE HYDROCHLORIDE HI TECH PHARMA 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 PHARMS CORP Type 1 - New Molecular Entity Approval
02/13/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #209469
ORIG-1 MOXIFLOXACIN HYDROCHLORIDE ALEMBIC PHARMS LTD 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 PHARMS CORP 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 INGENUS PHARMS LLC Approval
02/14/2019 IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #210676
ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN AUROBINDO PHARMA LTD Approval
02/15/2019 ELIGARD
NDA #021343
SUPPL-39 LEUPROLIDE ACETATE TOLMAR THERAP Labeling Approval
02/15/2019 ELIGARD
NDA #021379
SUPPL-41 LEUPROLIDE ACETATE TOLMAR THERAP Labeling Approval
02/15/2019 ELIGARD
NDA #021488
SUPPL-36 LEUPROLIDE ACETATE TOLMAR THERAP Labeling Approval
02/15/2019 ELIGARD
NDA #021731
SUPPL-37 LEUPROLIDE ACETATE TOLMAR THERAP 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 PHARMS 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 ASTRAZENECA AB Efficacy Approval
02/15/2019 CLOTRIMAZOLE
ANDA #209815
ORIG-1 CLOTRIMAZOLE NOVITIUM PHARMA Approval
02/15/2019 EVEROLIMUS
ANDA #210050
ORIG-1 EVEROLIMUS TEVA PHARMS USA INC Tentative 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 INC 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 LAKE Manufacturing (CMC) Approval
02/19/2019 AZITHROMYCIN
ANDA #209045
SUPPL-1 AZITHROMYCIN SUNSHINE LAKE Manufacturing (CMC) Approval
02/19/2019 ACETAZOLAMIDE
ANDA #210423
ORIG-1 ACETAZOLAMIDE ALEMBIC PHARMS LTD Approval
02/19/2019 LEVOTHYROXINE SODIUM
ANDA #210831
ORIG-1 LEVOTHYROXINE SODIUM AMNEAL PHARMS LLC Approval
02/19/2019 BUPIVACAINE HYDROCHLORIDE
ANDA #211096
ORIG-1 BUPIVACAINE HYDROCHLORIDE NOVOCOL HEALTHCARE 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 INC Labeling Approval
02/20/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #204104
ORIG-1 BENDAMUSTINE HYDROCHLORIDE MYLAN LABS LTD Tentative Approval
02/20/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #204771
ORIG-1 BENDAMUSTINE HYDROCHLORIDE GLENMARK PHARMS LTD Tentative Approval
02/20/2019 ESOMEPRAZOLE MAGNESIUM; NAPROXEN
ANDA #204920
ORIG-1 ESOMEPRAZOLE MAGNESIUM;NAPROXEN MYLAN PHARMS INC Tentative Approval
02/20/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #205447
ORIG-1 BENDAMUSTINE HYDROCHLORIDE BRECKENRIDGE PHARM Tentative Approval
02/20/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #205574
ORIG-1 BENDAMUSTINE HYDROCHLORIDE ACCORD HLTHCARE Tentative Approval
02/20/2019 ACYCLOVIR
ANDA #205659
ORIG-1 ACYCLOVIR PERRIGO UK FINCO 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 NOVARTIS PHARMS CORP 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 INC Labeling Approval
02/21/2019 IBUPROFEN
ANDA #078682
SUPPL-21 IBUPROFEN BIONPHARMA INC 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 DIMETHYL FUMARATE
ANDA #210500
ORIG-1 DIMETHYL FUMARATE HETERO LABS LTD III Tentative Approval
02/21/2019 EXEMESTANE
ANDA #211031
ORIG-1 EXEMESTANE BRECKENRIDGE PHARM 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 HOFFMANN LA ROCHE 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 PHARMS 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 MYLAN Labeling Approval
02/22/2019 NIACIN
ANDA #203742
ORIG-1 NIACIN MYLAN 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 INDICUS PHARMA 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 MEDICARE LTD 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 LUPIN LTD Approval
02/22/2019 EXEMESTANE
ANDA #209208
SUPPL-2 EXEMESTANE UPSHER SMITH LABS Labeling Approval
02/22/2019 TRANEXAMIC ACID
ANDA #209326
ORIG-1 TRANEXAMIC ACID ACIC PHARMS Approval
02/22/2019 BUSULFAN
ANDA #210148
ORIG-1 BUSULFAN ACCORD HLTHCARE INC 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 LAKE 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 ABBVIE 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 ABBVIE 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 ETHANOLATE; 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 INC Approval
02/26/2019 AZITHROMYCIN
ANDA #210001
ORIG-1 AZITHROMYCIN BIONPHARMA INC Approval
02/26/2019 HYDROXYZINE HYDROCHLORIDE
ANDA #210634
ORIG-1 HYDROXYZINE HYDROCHLORIDE TORRENT Approval
02/26/2019 CHLORTHALIDONE
ANDA #211063
ORIG-1 CHLORTHALIDONE INVATECH PHARMA 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
NDA #208583
SUPPL-8 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
02/27/2019 XULTOPHY 100/3.6
NDA #208583
SUPPL-10 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
02/27/2019 XULTOPHY 100/3.6
NDA #208583
SUPPL-11 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
02/27/2019 SOLIQUA 100/33
NDA #208673
SUPPL-7 INSULIN GLARGINE; LIXISENATIDE SANOFI-AVENTIS US Efficacy 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 THERAP Labeling Approval
02/28/2019 ALOGLIPTIN
ANDA #210073
ORIG-1 ALOGLIPTIN SUNSHINE LAKE Tentative Approval
02/28/2019 OXYBUTYNIN CHLORIDE
ANDA #211655
ORIG-1 OXYBUTYNIN CHLORIDE AJANTA PHARMA LTD Approval
02/28/2019 ARGATROBAN
NDA #212035
ORIG-1 ARGATROBAN ACCORD HLTHCARE INC Type 5 - New Formulation or New Manufacturer Tentative Approval
02/28/2019 HERCEPTIN HYLECTA
BLA #761106
ORIG-1 TRASTUZUMAB;HYALURONIDASE-OYSK GENENTECH INC Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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