Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 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 December 16, 2019.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/02/2019 SOLAGE
NDA #020922
SUPPL-7 MEQUINOL; TRETINOIN ALMIRALL Labeling Approval
12/02/2019 MELOXICAM
ANDA #078008
SUPPL-15 MELOXICAM AUROBINDO PHARMA Labeling Approval
12/02/2019 MELOXICAM
ANDA #078008
SUPPL-16 MELOXICAM AUROBINDO PHARMA Labeling Approval
12/02/2019 XURIDEN
NDA #208169
SUPPL-3 URIDINE TRIACETATE WELLSTAT THERAP Efficacy Approval
12/02/2019 SUCRALFATE
ANDA #209356
ORIG-1 SUCRALFATE AMNEAL PHARMS LLC Approval
12/02/2019 LORCASERIN HYDROCHLORIDE
ANDA #209464
ORIG-1 LORCASERIN HYDROCHLORIDE ZYDUS PHARMS USA INC Tentative Approval
12/02/2019 STERILE WATER FOR INJECTION
ANDA #211188
ORIG-1 STERILE WATER FOR INJECTION MEDEFIL INC Approval
12/03/2019 APOKYN
NDA #021264
SUPPL-17 APOMORPHINE HYDROCHLORIDE US WORLDMEDS Labeling Approval
12/03/2019 INCRELEX
NDA #021839
SUPPL-24 MECASERMIN RECOMBINANT IPSEN INC Labeling Approval
12/03/2019 TERBINAFINE HYDROCHLORIDE
ANDA #078297
SUPPL-16 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/03/2019 TERBINAFINE HYDROCHLORIDE
ANDA #078297
SUPPL-17 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/03/2019 TERBINAFINE HYDROCHLORIDE
ANDA #078297
SUPPL-18 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/03/2019 TERBINAFINE HYDROCHLORIDE
ANDA #078297
SUPPL-20 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/03/2019 NAPROXEN SODIUM
ANDA #078432
SUPPL-4 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
12/03/2019 NAPROXEN SODIUM
ANDA #078432
SUPPL-6 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
12/03/2019 NAPROXEN SODIUM
ANDA #078432
SUPPL-9 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
12/03/2019 GALANTAMINE HYDROBROMIDE
ANDA #090178
SUPPL-9 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
12/03/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #091118
ORIG-2 MINOCYCLINE HYDROCHLORIDE SUN PHARM INDS LTD Approval
12/03/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #091118
ORIG-3 MINOCYCLINE HYDROCHLORIDE SUN PHARM INDS LTD Tentative Approval
12/03/2019 ESZOPICLONE
ANDA #202929
SUPPL-8 ESZOPICLONE MACLEODS PHARMS LTD Labeling Approval
12/03/2019 ESZOPICLONE
ANDA #202929
SUPPL-9 ESZOPICLONE MACLEODS PHARMS LTD Labeling Approval
12/03/2019 ESZOPICLONE
ANDA #202929
SUPPL-13 ESZOPICLONE MACLEODS PHARMS LTD Labeling Approval
12/03/2019 ZOLMITRIPTAN
ANDA #204041
SUPPL-3 ZOLMITRIPTAN AJANTA PHARMA LTD Labeling Approval
12/03/2019 SIRTURO
NDA #204384
SUPPL-11 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
12/03/2019 JYNARQUE
NDA #204441
SUPPL-7 TOLVAPTAN OTSUKA PHARM CO LTD REMS Approval
12/03/2019 NAFTIFINE HYDROCHLORIDE
ANDA #205975
SUPPL-1 NAFTIFINE HYDROCHLORIDE TARO PHARMS Labeling Approval
12/03/2019 NAFTIFINE HYDROCHLORIDE
ANDA #206901
SUPPL-1 NAFTIFINE HYDROCHLORIDE TARO PHARMS Labeling Approval
12/03/2019 NAFTIFINE HYDROCHLORIDE
ANDA #206901
SUPPL-2 NAFTIFINE HYDROCHLORIDE TARO PHARMS Labeling Approval
12/03/2019 DESCOVY
NDA #208215
SUPPL-11 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/03/2019 ODEFSEY
NDA #208351
SUPPL-10 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/03/2019 MOXIFLOXACIN
ANDA #208778
ORIG-1 MOXIFLOXACIN GLAND PHARMA LTD Tentative Approval
12/03/2019 OSELTAMIVIR PHOSPHATE
ANDA #209113
SUPPL-2 OSELTAMIVIR PHOSPHATE NESHER PHARMS Labeling Approval
12/03/2019 OSELTAMIVIR PHOSPHATE
ANDA #209113
SUPPL-3 OSELTAMIVIR PHOSPHATE NESHER PHARMS Labeling Approval
12/03/2019 OSELTAMIVIR PHOSPHATE
ANDA #209113
SUPPL-5 OSELTAMIVIR PHOSPHATE NESHER PHARMS Labeling Approval
12/03/2019 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #209837
SUPPL-4 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE PERRIGO R AND D Labeling Approval
12/03/2019 DICLOFENAC POTASSIUM
ANDA #210078
ORIG-1 DICLOFENAC POTASSIUM STRIDES PHARMA Approval
12/03/2019 BROMFENAC SODIUM
ANDA #210962
ORIG-1 BROMFENAC SODIUM AMNEAL PHARMS CO Tentative Approval
12/03/2019 GABAPENTIN
ANDA #211330
ORIG-1 GABAPENTIN VISTAPHARM Approval
12/03/2019 VIGABATRIN
ANDA #211592
ORIG-1 VIGABATRIN INVAGEN PHARMS Approval
12/03/2019 TECENTRIQ
BLA #761034
SUPPL-21 ATEZOLIZUMAB GENENTECH INC Approval
12/04/2019 CARDIOLITE
NDA #019785
SUPPL-22 TECHNETIUM TC-99M SESTAMIBI KIT LANTHEUS MEDCL Labeling Approval
12/04/2019 MIRALUMA
NDA #019785
SUPPL-22 TECHNETIUM TC-99M SESTAMIBI KIT LANTHEUS MEDCL Labeling Approval
12/04/2019 THALOMID
NDA #020785
SUPPL-68 THALIDOMIDE CELGENE Labeling Approval
12/04/2019 EXTRANEAL
NDA #021321
SUPPL-37 ICODEXTRIN BAXTER HLTHCARE REMS Approval
12/04/2019 AMOXICILLIN
ANDA #061926
SUPPL-131 AMOXICILLIN TEVA Labeling Approval
12/04/2019 AMOXICILLIN
ANDA #061931
SUPPL-52 AMOXICILLIN TEVA Labeling Approval
12/04/2019 AMOXICILLIN PEDIATRIC
ANDA #061931
SUPPL-52 AMOXICILLIN TEVA Labeling Approval
12/04/2019 AMOXICILLIN
ANDA #064013
SUPPL-57 AMOXICILLIN TEVA Labeling Approval
12/04/2019 MEMANTINE HYDROCHLORIDE
ANDA #090058
SUPPL-5 MEMANTINE HYDROCHLORIDE SUN PHARM Labeling Approval
12/04/2019 MEMANTINE HYDROCHLORIDE
ANDA #090058
SUPPL-11 MEMANTINE HYDROCHLORIDE SUN PHARM Labeling Approval
12/04/2019 ALDURAZYME
BLA #125058
SUPPL-244 LARONIDASE BIOMARIN Approval
12/04/2019 VIMIZIM
BLA #125460
SUPPL-17 ELOSULFASE ALFA BIOMARIN PHARM Approval
12/04/2019 LATUDA
NDA #200603
SUPPL-35 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Labeling Approval
12/04/2019 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
ANDA #205833
SUPPL-8 MOXIFLOXACIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
12/04/2019 FINGOLIMOD HYDROCHLORIDE
ANDA #207939
ORIG-1 FINGOLIMOD HYDROCHLORIDE HEC PHARM CO LTD Approval
12/04/2019 FINGOLIMOD HYDROCHLORIDE
ANDA #207979
ORIG-1 FINGOLIMOD HYDROCHLORIDE BIOCON LTD Approval
12/04/2019 FINGOLIMOD HYDROCHLORIDE
ANDA #208014
ORIG-1 FINGOLIMOD HYDROCHLORIDE SUN PHARM Approval
12/04/2019 MINOXIDIL (FOR MEN)
ANDA #209074
SUPPL-1 MINOXIDIL TARO Labeling Approval
12/04/2019 MINOXIDIL (FOR MEN)
ANDA #209074
SUPPL-2 MINOXIDIL TARO Labeling Approval
12/04/2019 MINOXIDIL (FOR WOMEN)
ANDA #209074
SUPPL-1 MINOXIDIL TARO Labeling Approval
12/04/2019 MINOXIDIL (FOR WOMEN)
ANDA #209074
SUPPL-2 MINOXIDIL TARO Labeling Approval
12/04/2019 HARVONI
NDA #212477
SUPPL-4 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
12/04/2019 SOVALDI
NDA #212480
SUPPL-3 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
12/04/2019 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #212791
ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE SLAYBACK PHARMA LLC Approval
12/05/2019 SENSIPAR
NDA #021688
SUPPL-27 CINACALCET HYDROCHLORIDE AMGEN Labeling Approval
12/05/2019 MECLIZINE HYDROCHLORIDE
ANDA #040659
SUPPL-8 MECLIZINE HYDROCHLORIDE JUBILANT CADISTA Labeling Approval
12/05/2019 MECLIZINE HYDROCHLORIDE
ANDA #040659
SUPPL-10 MECLIZINE HYDROCHLORIDE JUBILANT CADISTA Labeling Approval
12/05/2019 SYLVANT
BLA #125496
SUPPL-18 SILTUXIMAB JANSSEN BIOTECH Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-4 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-5 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-6 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-7 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-10 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-13 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632
SUPPL-14 MOXIFLOXACIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/05/2019 DUOPA
NDA #203952
SUPPL-10 CARBIDOPA; LEVODOPA ABBVIE INC Labeling Approval
12/05/2019 EMGALITY
BLA #761063
SUPPL-4 GALCANEZUMAB-GNLM ELI LILLY AND CO Approval
12/06/2019 ABRAXANE
NDA #021660
SUPPL-46 PACLITAXEL ABRAXIS BIOSCIENCE Efficacy Approval
12/06/2019 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434
SUPPL-13 ARGATROBAN EAGLE PHARMS Labeling Approval
12/06/2019 NEVIRAPINE
ANDA #077956
SUPPL-22 NEVIRAPINE CIPLA Labeling Approval
12/06/2019 NEVIRAPINE
ANDA #077956
SUPPL-23 NEVIRAPINE CIPLA Labeling Approval
12/06/2019 NEVIRAPINE
ANDA #077956
SUPPL-24 NEVIRAPINE CIPLA Labeling Approval
12/06/2019 ZALEPLON
ANDA #078147
SUPPL-2 ZALEPLON HIKMA PHARMS Labeling Approval
12/06/2019 GALANTAMINE HYDROBROMIDE
ANDA #078484
SUPPL-8 GALANTAMINE HYDROBROMIDE IMPAX LABS Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078947
SUPPL-32 LAMOTRIGINE TORRENT PHARMS Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078947
SUPPL-33 LAMOTRIGINE TORRENT PHARMS Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078947
SUPPL-34 LAMOTRIGINE TORRENT PHARMS Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078956
SUPPL-21 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078956
SUPPL-23 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078956
SUPPL-26 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #078956
SUPPL-29 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #079132
SUPPL-20 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #079132
SUPPL-23 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/06/2019 PROPYLTHIOURACIL
ANDA #080172
SUPPL-57 PROPYLTHIOURACIL ACTAVIS ELIZABETH Labeling Approval
12/06/2019 PROPYLTHIOURACIL
ANDA #080172
SUPPL-60 PROPYLTHIOURACIL ACTAVIS ELIZABETH Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #090401
SUPPL-16 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #090401
SUPPL-19 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #090401
SUPPL-23 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #090401
SUPPL-24 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/06/2019 DIDANOSINE
ANDA #090788
SUPPL-4 DIDANOSINE MYLAN PHARMS INC Labeling Approval
12/06/2019 DIDANOSINE
ANDA #090788
SUPPL-7 DIDANOSINE MYLAN PHARMS INC Labeling Approval
12/06/2019 DIDANOSINE
ANDA #090788
SUPPL-8 DIDANOSINE MYLAN PHARMS INC Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #200220
SUPPL-6 LAMOTRIGINE JUBILANT GENERICS Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #200220
SUPPL-7 LAMOTRIGINE JUBILANT GENERICS Labeling Approval
12/06/2019 NAPROXEN SODIUM
ANDA #200629
SUPPL-6 NAPROXEN SODIUM AUROBINDO PHARMA LTD Labeling Approval
12/06/2019 NAPROXEN SODIUM
ANDA #200629
SUPPL-7 NAPROXEN SODIUM AUROBINDO PHARMA LTD Labeling Approval
12/06/2019 NAPROXEN SODIUM
ANDA #200629
SUPPL-10 NAPROXEN SODIUM AUROBINDO PHARMA LTD Labeling Approval
12/06/2019 ALOSETRON HYDROCHLORIDE
ANDA #200652
SUPPL-5 ALOSETRON HYDROCHLORIDE HIKMA Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #200694
SUPPL-1 LAMOTRIGINE ALKEM LABS LTD Labeling Approval
12/06/2019 LAMOTRIGINE
ANDA #200694
SUPPL-3 LAMOTRIGINE ALKEM LABS LTD Labeling Approval
12/06/2019 QUETIAPINE FUMARATE
ANDA #203359
SUPPL-9 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
12/06/2019 QUETIAPINE FUMARATE
ANDA #203359
SUPPL-13 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
12/06/2019 ARIPIPRAZOLE
ANDA #204171
SUPPL-3 ARIPIPRAZOLE LANNETT CO INC Labeling Approval
12/06/2019 ZOLMITRIPTAN
ANDA #204232
SUPPL-6 ZOLMITRIPTAN ALEMBIC PHARMS LTD Labeling Approval
12/06/2019 MONTELUKAST SODIUM
ANDA #204604
SUPPL-1 MONTELUKAST SODIUM AMNEAL PHARMS Labeling Approval
12/06/2019 MONTELUKAST SODIUM
ANDA #204604
SUPPL-2 MONTELUKAST SODIUM AMNEAL PHARMS Labeling Approval
12/06/2019 MONTELUKAST SODIUM
ANDA #204604
SUPPL-3 MONTELUKAST SODIUM AMNEAL PHARMS Labeling Approval
12/06/2019 CELECOXIB
ANDA #204776
SUPPL-3 CELECOXIB MICRO LABS Labeling Approval
12/06/2019 CELECOXIB
ANDA #204776
SUPPL-6 CELECOXIB MICRO LABS Labeling Approval
12/06/2019 KITABIS PAK
NDA #205433
SUPPL-5 TOBRAMYCIN PULMOFLOW INC Labeling Approval
12/06/2019 ALOSETRON HYDROCHLORIDE
ANDA #206113
SUPPL-2 ALOSETRON HYDROCHLORIDE PAR PHARM INC Labeling Approval
12/06/2019 VIEKIRA PAK (COPACKAGED)
NDA #206619
SUPPL-20 DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE INC Labeling Approval
12/06/2019 ALOSETRON HYDROCHLORIDE
ANDA #206647
SUPPL-4 ALOSETRON HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
12/06/2019 TECHNIVIE
NDA #207931
SUPPL-13 OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE INC Labeling Approval
12/06/2019 VIEKIRA XR
NDA #208624
SUPPL-8 DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE INC Labeling Approval
12/06/2019 MEPSEVII
BLA #761047
SUPPL-3 VESTRONIDASE ALFA-VJBK ULTRAGENYX PHARM INC Approval
12/06/2019 BRINEURA
BLA #761052
SUPPL-7 CERLIPONASE ALFA BIOMARIN PHARM Approval
12/06/2019 AVSOLA
BLA #761086
ORIG-1 INFLIXIMAB-AXXQ AMGEN INC Approval
12/09/2019 NAPROXEN SODIUM
NDA #021920
SUPPL-26 NAPROXEN SODIUM BIONPHARMA INC Labeling Approval
12/09/2019 VALPROIC ACID
ANDA #073484
SUPPL-31 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/09/2019 VALPROIC ACID
ANDA #073484
SUPPL-32 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/09/2019 VALPROIC ACID
ANDA #073484
SUPPL-34 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/09/2019 VALPROIC ACID
ANDA #073484
SUPPL-37 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/09/2019 VALPROIC ACID
ANDA #073484
SUPPL-38 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/09/2019 RAMIPRIL
ANDA #077004
SUPPL-2 RAMIPRIL CIPLA Labeling Approval
12/09/2019 RAMIPRIL
ANDA #077004
SUPPL-4 RAMIPRIL CIPLA Labeling Approval
12/09/2019 RISPERIDONE
ANDA #077494
SUPPL-15 RISPERIDONE PAR PHARM Labeling Approval
12/09/2019 RISPERIDONE
ANDA #077494
SUPPL-16 RISPERIDONE PAR PHARM Labeling Approval
12/09/2019 RAMIPRIL
ANDA #077900
SUPPL-13 RAMIPRIL HIKMA Labeling Approval
12/09/2019 RAMIPRIL
ANDA #077900
SUPPL-14 RAMIPRIL HIKMA Labeling Approval
12/09/2019 RAMIPRIL
ANDA #079116
SUPPL-8 RAMIPRIL APOTEX Labeling Approval
12/09/2019 RAMIPRIL
ANDA #079116
SUPPL-9 RAMIPRIL APOTEX Labeling Approval
12/09/2019 RAMIPRIL
ANDA #079116
SUPPL-10 RAMIPRIL APOTEX Labeling Approval
12/09/2019 BETHKIS
NDA #201820
SUPPL-5 TOBRAMYCIN CHIESI USA INC Labeling Approval
12/09/2019 FENOFIBRATE (MICRONIZED)
ANDA #202252
SUPPL-4 FENOFIBRATE APOTEX Labeling Approval
12/09/2019 FENOFIBRATE (MICRONIZED)
ANDA #202252
SUPPL-5 FENOFIBRATE APOTEX Labeling Approval
12/09/2019 FENOFIBRATE (MICRONIZED)
ANDA #202252
SUPPL-6 FENOFIBRATE APOTEX Labeling Approval
12/09/2019 FENOFIBRATE (MICRONIZED)
ANDA #202252
SUPPL-7 FENOFIBRATE APOTEX Labeling Approval
12/09/2019 RILUZOLE
ANDA #206045
ORIG-1 RILUZOLE STANDARD CHEM PHARM Approval
12/09/2019 CRESEMBA
NDA #207500
SUPPL-5 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
12/09/2019 CRESEMBA
NDA #207501
SUPPL-4 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
12/09/2019 EVEROLIMUS
ANDA #207934
ORIG-1 EVEROLIMUS PAR PHARM Approval
12/09/2019 EVEROLIMUS
ANDA #207934
ORIG-2 EVEROLIMUS PAR PHARM Tentative Approval
12/09/2019 SODIUM TETRADECYL SULFATE
ANDA #209937
ORIG-1 SODIUM TETRADECYL SULFATE CUSTOPHARM INC Approval
12/09/2019 EVEROLIMUS
ANDA #210050
ORIG-1 EVEROLIMUS TEVA PHARMS USA Approval
12/09/2019 AMBRISENTAN
ANDA #210058
SUPPL-1 AMBRISENTAN ZYDUS PHARMS Labeling Approval
12/09/2019 AMBRISENTAN
ANDA #210058
SUPPL-2 AMBRISENTAN ZYDUS PHARMS Labeling Approval
12/10/2019 VALTREX
NDA #020487
SUPPL-20 VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/10/2019 FORFIVO XL
NDA #022497
SUPPL-8 BUPROPION HYDROCHLORIDE ALVOGEN Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076720
SUPPL-22 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076720
SUPPL-24 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076720
SUPPL-25 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076733
SUPPL-21 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076733
SUPPL-23 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #076733
SUPPL-24 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 NEVIRAPINE
ANDA #077521
SUPPL-18 NEVIRAPINE AUROBINDO Labeling Approval
12/10/2019 NEVIRAPINE
ANDA #077521
SUPPL-20 NEVIRAPINE AUROBINDO Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #077855
SUPPL-19 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #077855
SUPPL-21 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 MORPHINE SULFATE
ANDA #077855
SUPPL-22 MORPHINE SULFATE NESHER PHARMS Labeling Approval
12/10/2019 NAPROXEN SODIUM
ANDA #078486
SUPPL-2 NAPROXEN SODIUM DR REDDYS LABS LTD Labeling Approval
12/10/2019 NAPROXEN SODIUM
ANDA #078486
SUPPL-3 NAPROXEN SODIUM DR REDDYS LABS LTD Labeling Approval
12/10/2019 NAPROXEN SODIUM
ANDA #078486
SUPPL-4 NAPROXEN SODIUM DR REDDYS LABS LTD Labeling Approval
12/10/2019 NAPROXEN SODIUM
ANDA #078486
SUPPL-7 NAPROXEN SODIUM DR REDDYS LABS LTD Labeling Approval
12/10/2019 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #202491
SUPPL-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TEVA PHARMS USA Labeling Approval
12/10/2019 ARIPIPRAZOLE
ANDA #203906
SUPPL-7 ARIPIPRAZOLE AMNEAL PHARMS Labeling Approval
12/10/2019 XOFIGO
NDA #203971
SUPPL-16 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Labeling Approval
12/10/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635
SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
12/10/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635
SUPPL-3 MOXIFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
12/10/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635
SUPPL-4 MOXIFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
12/10/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635
SUPPL-6 MOXIFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
12/10/2019 DESVENLAFAXINE
NDA #205583
SUPPL-10 DESVENLAFAXINE FUMARATE SUN PHARMA GLOBAL Labeling Approval
12/10/2019 NAFCILLIN SODIUM
ANDA #206682
ORIG-1 NAFCILLIN SODIUM FRESENIUS Approval
12/11/2019 PERSANTINE
NDA #012836
SUPPL-61 DIPYRIDAMOLE BOEHRINGER INGELHEIM Labeling Approval
12/11/2019 AGGRENOX
NDA #020884
SUPPL-39 ASPIRIN; DIPYRIDAMOLE BOEHRINGER INGELHEIM Labeling Approval
12/11/2019 XERESE
NDA #022436
SUPPL-10 ACYCLOVIR; HYDROCORTISONE BAUSCH Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #090120
SUPPL-8 QUETIAPINE FUMARATE HIKMA Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #090120
SUPPL-9 QUETIAPINE FUMARATE HIKMA Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #090749
SUPPL-7 QUETIAPINE FUMARATE HIKMA Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #090749
SUPPL-8 QUETIAPINE FUMARATE HIKMA Labeling Approval
12/11/2019 ESZOPICLONE
ANDA #091153
SUPPL-2 ESZOPICLONE HIKMA Labeling Approval
12/11/2019 ESZOPICLONE
ANDA #091153
SUPPL-3 ESZOPICLONE HIKMA Labeling Approval
12/11/2019 ESZOPICLONE
ANDA #091153
SUPPL-4 ESZOPICLONE HIKMA Labeling Approval
12/11/2019 CAPECITABINE
ANDA #200483
SUPPL-2 CAPECITABINE HIKMA Labeling Approval
12/11/2019 CAPECITABINE
ANDA #200483
SUPPL-5 CAPECITABINE HIKMA Labeling Approval
12/11/2019 VAZALORE
NDA #203697
SUPPL-4 ASPIRIN PLX PHARMA Labeling Approval
12/11/2019 TECFIDERA
NDA #204063
SUPPL-25 DIMETHYL FUMARATE BIOGEN IDEC INC Labeling Approval
12/11/2019 QUININE SULFATE
ANDA #204372
SUPPL-1 QUININE SULFATE NOVAST LABS Labeling Approval
12/11/2019 ORBACTIV
NDA #206334
SUPPL-5 ORITAVANCIN DIPHOSPHATE MELINTA THERAP Labeling Approval
12/11/2019 ZEPATIER
NDA #208261
SUPPL-6 ELBASVIR; GRAZOPREVIR MERCK SHARP DOHME Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #208947
SUPPL-1 QUETIAPINE FUMARATE NOVAST LABS Labeling Approval
12/11/2019 QUETIAPINE FUMARATE
ANDA #208947
SUPPL-2 QUETIAPINE FUMARATE NOVAST LABS Labeling Approval
12/11/2019 FLUOROURACIL
ANDA #209271
ORIG-1 FLUOROURACIL INGENUS PHARMS LLC Approval
12/11/2019 DOFETILIDE
ANDA #210466
SUPPL-1 DOFETILIDE SUN PHARM Labeling Approval
12/11/2019 ELURYNG
ANDA #210830
ORIG-1 ETHINYL ESTRADIOL; ETONOGESTREL AMNEAL PHARMS LLC Approval
12/11/2019 SOLIFENACIN SUCCINATE
ANDA #211423
ORIG-1 SOLIFENACIN SUCCINATE CSPC OUYI Approval
12/11/2019 AZITHROMYCIN
ANDA #211521
ORIG-1 AZITHROMYCIN TARO Approval
12/11/2019 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #212037
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SUNGEN PHARMA Approval
12/12/2019 DIVIGEL
NDA #022038
SUPPL-5 ESTRADIOL VERTICAL PHARMS LLC Labeling Approval
12/12/2019 DIVIGEL
NDA #022038
SUPPL-6 ESTRADIOL VERTICAL PHARMS LLC Efficacy Approval
12/12/2019 PUR-WASH
NDA #022305
SUPPL-6 PURIFIED WATER NIAGARA PHARMS Labeling Approval
12/12/2019 ELITEK
BLA #103946
SUPPL-5103 RASBURICASE SANOFI SYNTHELABO Approval
12/12/2019 XELJANZ
NDA #203214
SUPPL-25 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
12/12/2019 IBANDRONATE SODIUM
ANDA #206058
SUPPL-1 IBANDRONATE SODIUM ACCORD HLTHCARE Labeling Approval
12/12/2019 AZELASTINE HYDROCHLORIDE
ANDA #207243
SUPPL-1 AZELASTINE HYDROCHLORIDE HIKMA Labeling Approval
12/12/2019 XELJANZ XR
NDA #208246
SUPPL-9 TOFACITINIB CITRATE PFIZER INC Efficacy Approval
12/12/2019 VYONDYS 53
NDA #211970
ORIG-1 GOLODIRSEN SAREPTA THERAPEUTICS INC Type 1 - New Molecular Entity Approval
12/13/2019 CARNEXIV
NDA #206030
SUPPL-2 CARBAMAZEPINE LUNDBECK PHARMS LLC Labeling Approval

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