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 February 19, 2019.

 

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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 PREGABALIN
ANDA #207623
ORIG-1 PREGABALIN ALKEM LABS LTD Tentative 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 PHARMA GLOBAL Labeling Approval
02/02/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090362
SUPPL-8 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARMA GLOBAL 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 MAGNA PHARMS 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 WATSON LABS 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 INDS LTD 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 PHARMS INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885
SUPPL-5 RABEPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885
SUPPL-6 RABEPRAZOLE SODIUM MYLAN PHARMS INC Labeling Approval
02/07/2019 RABEPRAZOLE SODIUM
ANDA #076885
SUPPL-8 RABEPRAZOLE SODIUM MYLAN PHARMS INC 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 DESVENLAFAXINE
ANDA #204805
ORIG-1 DESVENLAFAXINE INTELLIPHARMACEUTICS Tentative Approval
02/07/2019 CARBAMAZEPINE
ANDA #205571
ORIG-1 CARBAMAZEPINE ZYDUS PHARMS USA INC 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
02/08/2019 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 DEFERIPRONE
ANDA #208800
ORIG-1 DEFERIPRONE TARO PHARM INDS Approval
02/08/2019 APIXABAN
ANDA #209944
ORIG-1 APIXABAN SUNSHINE LAKE Tentative Approval
02/08/2019 ESTRADIOL
ANDA #211396
ORIG-1 ESTRADIOL AMNEAL PHARMS Tentative 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 USA INC 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 VALEANT Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845
SUPPL-1 LINEZOLID MYLAN PHARMS INC Labeling Approval
02/12/2019 LINEZOLID
ANDA #078845
SUPPL-2 LINEZOLID MYLAN PHARMS INC 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 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 IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #210676
ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN AUROBINDO PHARMA LTD Approval
02/15/2019 KEYTRUDA
BLA #125514
SUPPL-40 PEMBROLIZUMAB MERCK SHARP DOHME 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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