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 February 29, 2020.

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 Labeling 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 LAMIVUDINE AND ZIDOVUDINE
ANDA #077411
SUPPL-28 LAMIVUDINE; ZIDOVUDINE CIPLA Labeling Approval
12/12/2019 ABACAVIR SULFATE
ANDA #078119
SUPPL-25 ABACAVIR SULFATE CIPLA 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 CARNEXIV
NDA #206030
SUPPL-2 CARBAMAZEPINE LUNDBECK PHARMS LLC 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 TROPICAMIDE
ANDA #207524
ORIG-1 TROPICAMIDE SOMERSET THERAPS LLC Approval
12/12/2019 IMIPENEM AND CILASTATIN
ANDA #207594
ORIG-1 CILASTATIN SODIUM; IMIPENEM HQ SPCLT PHARMA Approval
12/12/2019 XELJANZ XR
NDA #208246
SUPPL-9 TOFACITINIB CITRATE PFIZER INC Efficacy Approval
12/12/2019 FLUOROURACIL
ANDA #209219
ORIG-1 FLUOROURACIL INGENUS PHARMS LLC Approval
12/12/2019 VYONDYS 53
NDA #211970
ORIG-1 GOLODIRSEN SAREPTA THERAPS INC Type 1 - New Molecular Entity Approval
12/12/2019 BUMETANIDE
ANDA #212019
ORIG-1 BUMETANIDE RISING Approval
12/13/2019 PARLODEL
NDA #017962
SUPPL-81 BROMOCRIPTINE MESYLATE US PHARMS HOLDINGS I Labeling Approval
12/13/2019 DOSTINEX
NDA #020664
SUPPL-17 CABERGOLINE PHARMACIA AND UPJOHN Labeling Approval
12/13/2019 ARIXTRA
NDA #021345
SUPPL-37 FONDAPARINUX SODIUM MYLAN IRELAND LTD Labeling Approval
12/13/2019 KUVAN
NDA #022181
SUPPL-18 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Labeling Approval
12/13/2019 CETIRIZINE HYDROCHLORIDE ALLERGY
NDA #022429
SUPPL-14 CETIRIZINE HYDROCHLORIDE BIONPHARMA INC Manufacturing (CMC) Approval
12/13/2019 CETIRIZINE HYDROCHLORIDE HIVES RELIEF
NDA #022429
SUPPL-14 CETIRIZINE HYDROCHLORIDE BIONPHARMA INC Manufacturing (CMC) Approval
12/13/2019 CELLCEPT
NDA #050722
SUPPL-40 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
12/13/2019 CELLCEPT
NDA #050723
SUPPL-41 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
12/13/2019 CELLCEPT
NDA #050758
SUPPL-37 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
12/13/2019 CELLCEPT
NDA #050759
SUPPL-45 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
12/13/2019 CABERGOLINE
ANDA #076310
SUPPL-11 CABERGOLINE PAR PHARM Labeling Approval
12/13/2019 SERTRALINE HYDROCHLORIDE
ANDA #076671
SUPPL-12 SERTRALINE HYDROCHLORIDE MYLAN Labeling Approval
12/13/2019 CABERGOLINE
ANDA #077750
SUPPL-10 CABERGOLINE IVAX SUB TEVA PHARMS Labeling Approval
12/13/2019 CABERGOLINE
ANDA #077843
SUPPL-4 CABERGOLINE IMPAX LABS INC Labeling Approval
12/13/2019 CABERGOLINE
ANDA #078035
SUPPL-10 CABERGOLINE ACTAVIS LABS FL INC Labeling Approval
12/13/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647
SUPPL-7 TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Labeling Approval
12/13/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647
SUPPL-10 TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Labeling Approval
12/13/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #090679
SUPPL-16 LAMIVUDINE; ZIDOVUDINE MACLEODS PHARMS LTD Labeling Approval
12/13/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778
SUPPL-20 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/13/2019 QUININE SULFATE
ANDA #091661
SUPPL-7 QUININE SULFATE TEVA PHARMS Labeling Approval
12/13/2019 ERWINAZE
BLA #125359
SUPPL-98 asparaginase Erwinia chrysanthemi JAZZ PHARMS INC Approval
12/13/2019 MYALEPT
BLA #125390
SUPPL-17 METRELEPTIN AEGERION Approval
12/13/2019 ARMODAFINIL
ANDA #200043
SUPPL-6 ARMODAFINIL MYLAN PHARMS INC Labeling Approval
12/13/2019 ABACAVIR SULFATE
ANDA #201107
SUPPL-7 ABACAVIR SULFATE HETERO LABS LTD III Labeling Approval
12/13/2019 ABACAVIR SULFATE
ANDA #201107
SUPPL-8 ABACAVIR SULFATE HETERO LABS LTD III Labeling Approval
12/13/2019 VASCEPA
NDA #202057
SUPPL-35 ICOSAPENT ETHYL AMARIN PHARMS Efficacy Approval
12/13/2019 IBANDRONATE SODIUM
ANDA #202235
SUPPL-1 IBANDRONATE SODIUM SAGENT PHARMS INC Labeling Approval
12/13/2019 IBANDRONATE SODIUM
ANDA #202235
SUPPL-3 IBANDRONATE SODIUM SAGENT PHARMS INC Labeling Approval
12/13/2019 IBANDRONATE SODIUM
ANDA #202235
SUPPL-4 IBANDRONATE SODIUM SAGENT PHARMS INC Labeling Approval
12/13/2019 CABERGOLINE
ANDA #202947
SUPPL-1 CABERGOLINE MYLAN Labeling Approval
12/13/2019 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #203580
SUPPL-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TORRENT Labeling Approval
12/13/2019 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #203580
SUPPL-4 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TORRENT Labeling Approval
12/13/2019 QUININE SULFATE
ANDA #203729
SUPPL-2 QUININE SULFATE AMNEAL PHARMS Labeling Approval
12/13/2019 AMIKACIN SULFATE
ANDA #204040
SUPPL-5 AMIKACIN SULFATE EMCURE PHARMS LTD Labeling Approval
12/13/2019 AMIKACIN SULFATE
ANDA #204040
SUPPL-10 AMIKACIN SULFATE EMCURE PHARMS LTD Labeling Approval
12/13/2019 AMIKACIN SULFATE
ANDA #204040
SUPPL-14 AMIKACIN SULFATE EMCURE PHARMS LTD Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-7 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-8 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-9 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-12 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-14 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CLOPIDOGREL BISULFATE
ANDA #204165
SUPPL-15 CLOPIDOGREL BISULFATE SCIEGEN PHARMS INC Labeling Approval
12/13/2019 CABERGOLINE
ANDA #204735
SUPPL-1 CABERGOLINE INGENUS PHARMS LLC Labeling Approval
12/13/2019 KUVAN
NDA #205065
SUPPL-7 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Labeling Approval
12/13/2019 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #206703
SUPPL-1 CYCLOBENZAPRINE HYDROCHLORIDE APOTEX Labeling Approval
12/13/2019 ZERBAXA
NDA #206829
SUPPL-9 CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC Labeling Approval
12/13/2019 NAPROXEN SODIUM
ANDA #208363
SUPPL-3 NAPROXEN SODIUM PURACAP PHARM LLC Labeling Approval
12/13/2019 DEFERASIROX
ANDA #208697
ORIG-1 DEFERASIROX ACTAVIS ELIZABETH Approval
12/13/2019 FIRVANQ KIT
NDA #208910
SUPPL-4 VANCOMYCIN HYDROCHLORIDE RXMTM THERAPS LLC Labeling Approval
12/13/2019 TIGLUTIK KIT
NDA #209080
SUPPL-1 RILUZOLE ITALFARMACO SPA Efficacy Approval
12/13/2019 DOCETAXEL
ANDA #209634
SUPPL-3 DOCETAXEL CIPLA Labeling Approval
12/13/2019 MYCOPHENOLIC ACID
ANDA #211173
ORIG-1 MYCOPHENOLIC ACID CONCORD BIOTECH LTD Approval
12/13/2019 ZULRESSO
NDA #211371
SUPPL-4 BREXANOLONE SAGE THERAP REMS Approval
12/13/2019 LEVORPHANOL TARTRATE
ANDA #212024
ORIG-1 LEVORPHANOL TARTRATE SPECGX LLC Approval
12/13/2019 NOURESS
NDA #212535
ORIG-1 CYSTEINE HYDROCHLORIDE AVADEL LEGACY Type 5 - New Formulation or New Manufacturer Approval
12/13/2019 CAPTOPRIL
ANDA #212809
ORIG-1 CAPTOPRIL AJANTA PHARMA LTD Approval
12/16/2019 SURVANTA
NDA #020032
SUPPL-45 BERACTANT ABBVIE Labeling Approval
12/16/2019 CUROSURF
NDA #020744
SUPPL-40 PORACTANT ALFA CHIESI USA INC Labeling Approval
12/16/2019 VENTOLIN HFA
NDA #020983
SUPPL-36 ALBUTEROL SULFATE GLAXOSMITHKLINE Labeling Approval
12/16/2019 LUVOX
NDA #021519
SUPPL-12 FLUVOXAMINE MALEATE ANI PHARMS Labeling Approval
12/16/2019 VENTAVIS
NDA #021779
SUPPL-19 ILOPROST ACTELION PHARMS LTD Labeling Approval
12/16/2019 CLEOCIN
NDA #050537
SUPPL-41 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
12/16/2019 CLEOCIN T
NDA #050537
SUPPL-41 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
12/16/2019 CLEOCIN T
NDA #050600
SUPPL-18 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
12/16/2019 CLEOCIN T
NDA #050615
SUPPL-19 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
12/16/2019 TOPOTECAN HYDROCHLORIDE
NDA #200582
SUPPL-3 TOPOTECAN HYDROCHLORIDE HOSPIRA INC Labeling Approval
12/16/2019 XTANDI
NDA #203415
SUPPL-15 ENZALUTAMIDE ASTELLAS Efficacy Approval
12/16/2019 ASENAPINE
ANDA #206098
ORIG-1 ASENAPINE ALEMBIC PHARMS LTD Tentative Approval
12/16/2019 TADALAFIL
ANDA #208824
ORIG-1 TADALAFIL YANGLING BUCHANG PHARMA CO LTD Tentative Approval
12/16/2019 ZILEUTON
ANDA #212670
ORIG-1 ZILEUTON PAR PHARM INC Approval
12/16/2019 CAFFEINE CITRATE
ANDA #213202
ORIG-1 CAFFEINE CITRATE MICRO LABS Approval
12/17/2019 TAXOTERE
NDA #020449
SUPPL-83 DOCETAXEL SANOFI AVENTIS US Labeling Approval
12/17/2019 CLARITHROMYCIN
ANDA #065178
SUPPL-14 CLARITHROMYCIN HIKMA Labeling Approval
12/17/2019 CLARITHROMYCIN
ANDA #065178
SUPPL-15 CLARITHROMYCIN HIKMA Labeling Approval
12/17/2019 CLARITHROMYCIN
ANDA #065178
SUPPL-16 CLARITHROMYCIN HIKMA Labeling Approval
12/17/2019 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776
SUPPL-40 HYDROCHLOROTHIAZIDE; LISINOPRIL HERITAGE PHARMA Labeling Approval
12/17/2019 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776
SUPPL-42 HYDROCHLOROTHIAZIDE; LISINOPRIL HERITAGE PHARMA Labeling Approval
12/17/2019 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776
SUPPL-43 HYDROCHLOROTHIAZIDE; LISINOPRIL HERITAGE PHARMA Labeling Approval
12/17/2019 GLIPIZIDE
ANDA #076467
SUPPL-24 GLIPIZIDE WATSON LABS Labeling Approval
12/17/2019 GLIPIZIDE
ANDA #076467
SUPPL-25 GLIPIZIDE WATSON LABS Labeling Approval
12/17/2019 GLIPIZIDE
ANDA #076467
SUPPL-26 GLIPIZIDE WATSON LABS Labeling Approval
12/17/2019 LIOTHYRONINE SODIUM
ANDA #090097
SUPPL-13 LIOTHYRONINE SODIUM MAYNE PHARMA INC Labeling Approval
12/17/2019 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
ANDA #090145
SUPPL-4 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE NOVEL LABS INC Labeling Approval
12/17/2019 CAPECITABINE
ANDA #090943
SUPPL-5 CAPECITABINE MYLAN Labeling Approval
12/17/2019 CAPECITABINE
ANDA #090943
SUPPL-7 CAPECITABINE MYLAN Labeling Approval
12/17/2019 CAPECITABINE
ANDA #090943
SUPPL-12 CAPECITABINE MYLAN Labeling Approval
12/17/2019 CAPECITABINE
ANDA #091649
SUPPL-7 CAPECITABINE TEVA PHARMS USA Labeling Approval
12/17/2019 CAPECITABINE
ANDA #091649
SUPPL-10 CAPECITABINE TEVA PHARMS USA Labeling Approval
12/17/2019 NAGLAZYME
BLA #125117
SUPPL-129 GALSULFASE BIOMARIN Approval
12/17/2019 LAMOTRIGINE
ANDA #201168
SUPPL-7 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/17/2019 LAMOTRIGINE
ANDA #201168
SUPPL-13 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/17/2019 LAMOTRIGINE
ANDA #201168
SUPPL-14 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/17/2019 PARICALCITOL
NDA #201657
SUPPL-6 PARICALCITOL HOSPIRA INC Labeling Approval
12/17/2019 RYTARY
NDA #203312
SUPPL-11 CARBIDOPA; LEVODOPA IMPAX LABS INC Labeling Approval
12/17/2019 IBANDRONATE SODIUM
ANDA #203987
SUPPL-8 IBANDRONATE SODIUM EMCURE PHARMS LTD Labeling Approval
12/17/2019 ARIPIPRAZOLE
ANDA #204094
SUPPL-5 ARIPIPRAZOLE APOTEX INC Labeling Approval
12/17/2019 ARIPIPRAZOLE
ANDA #204094
SUPPL-7 ARIPIPRAZOLE APOTEX INC Labeling Approval
12/17/2019 IBANDRONATE SODIUM
ANDA #204222
SUPPL-1 IBANDRONATE SODIUM APOTEX Labeling Approval
12/17/2019 RAYALDEE
NDA #208010
SUPPL-5 CALCIFEDIOL OPKO IRELAND GLOBAL Labeling Approval
12/17/2019 OXYBUTYNIN CHLORIDE
ANDA #210717
ORIG-1 OXYBUTYNIN CHLORIDE BIONPHARMA INC Approval
12/17/2019 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #210817
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MAYNE PHARMA INC Approval
12/17/2019 DOFETILIDE
ANDA #211223
ORIG-1 DOFETILIDE PRINSTON INC Approval
12/17/2019 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #212082
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LANNETT CO INC Approval
12/17/2019 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #212083
ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LANNETT CO INC Approval
12/18/2019 DROXIA
NDA #016295
SUPPL-52 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
12/18/2019 HYDREA
NDA #016295
SUPPL-52 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
12/18/2019 SYMLIN
NDA #021332
SUPPL-28 PRAMLINTIDE ACETATE ASTRAZENECA AB Labeling Approval
12/18/2019 CADUET
NDA #021540
SUPPL-45 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PFIZER Labeling Approval
12/18/2019 DUAVEE
NDA #022247
SUPPL-6 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED WYETH PHARMS Labeling Approval
12/18/2019 FAMOTIDINE
ANDA #075512
SUPPL-17 FAMOTIDINE P AND L Labeling Approval
12/18/2019 FAMOTIDINE
ANDA #075512
SUPPL-20 FAMOTIDINE P AND L Labeling Approval
12/18/2019 OXALIPLATIN
ANDA #078811
SUPPL-14 OXALIPLATIN FRESENIUS KABI USA Labeling Approval
12/18/2019 LEUCOVORIN CALCIUM
ANDA #089717
SUPPL-31 LEUCOVORIN CALCIUM WEST-WARD PHARMS INT Labeling Approval
12/18/2019 KEPIVANCE
BLA #125103
SUPPL-176 PALIFERMIN BIOVITRUM AB Approval
12/18/2019 SITAVIG
NDA #203791
SUPPL-1 ACYCLOVIR EPI HLTH Labeling Approval
12/18/2019 HEMANGEOL
NDA #205410
SUPPL-3 PROPRANOLOL HYDROCHLORIDE PIERRE FABRE DERMA Labeling Approval
12/18/2019 TICAGRELOR
ANDA #208531
SUPPL-3 TICAGRELOR AMNEAL PHARMS CO Labeling Approval
12/18/2019 BETAMETHASONE DIPROPIONATE
ANDA #209106
ORIG-1 BETAMETHASONE DIPROPIONATE LUPIN LTD Approval
12/18/2019 ARAZLO
NDA #211882
ORIG-1 TAZAROTENE BAUSCH Approval
12/18/2019 DICLOFENAC SODIUM
ANDA #213040
ORIG-1 DICLOFENAC SODIUM AUROLIFE PHARMA LLC Tentative Approval
12/18/2019 TRUXIMA
BLA #761088
SUPPL-5 RITUXIMAB-ABBS CELLTRION INC Approval
12/18/2019 TRUXIMA
BLA #761088
SUPPL-6 RITUXIMAB-ABBS CELLTRION INC Approval
12/18/2019 PADCEV
BLA #761137
ORIG-1 ENFORTUMAB VEDOTIN-EJFV ASTELLAS Approval
12/19/2019 AN-SULFUR COLLOID
NDA #017858
SUPPL-49 TECHNETIUM TC-99M SULFUR COLLOID KIT PHARMALUCENCE Labeling Approval
12/19/2019 NORVIR
NDA #020659
SUPPL-71 RITONAVIR ABBVIE Labeling Approval
12/19/2019 NORVIR
NDA #020945
SUPPL-47 RITONAVIR ABBVIE Labeling Approval
12/19/2019 ASMANEX TWISTHALER
NDA #021067
SUPPL-29 MOMETASONE FUROATE MERCK SHARP DOHME Labeling Approval
12/19/2019 KALETRA
NDA #021226
SUPPL-48 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
12/19/2019 KALETRA
NDA #021251
SUPPL-58 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
12/19/2019 ENTEREG
NDA #021775
SUPPL-15 ALVIMOPAN CUBIST PHARMS REMS Approval
12/19/2019 INVIRASE
NDA #021785
SUPPL-24 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
12/19/2019 KALETRA
NDA #021906
SUPPL-53 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
12/19/2019 AMPYRA
NDA #022250
SUPPL-17 DALFAMPRIDINE ACORDA Labeling Approval
12/19/2019 NORVIR
NDA #022417
SUPPL-23 RITONAVIR ABBVIE Labeling Approval
12/19/2019 GABLOFEN
NDA #022462
SUPPL-11 BACLOFEN PIRAMAL CRITICAL Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065069
SUPPL-15 CEFUROXIME AXETIL APOTEX Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065069
SUPPL-16 CEFUROXIME AXETIL APOTEX Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065135
SUPPL-22 CEFUROXIME AXETIL LUPIN Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065135
SUPPL-24 CEFUROXIME AXETIL LUPIN Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065308
SUPPL-13 CEFUROXIME AXETIL AUROBINDO PHARMA LTD Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065308
SUPPL-15 CEFUROXIME AXETIL AUROBINDO PHARMA LTD Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065308
SUPPL-16 CEFUROXIME AXETIL AUROBINDO PHARMA LTD Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065496
SUPPL-10 CEFUROXIME AXETIL ALKEM LABS LTD Labeling Approval
12/19/2019 CEFUROXIME AXETIL
ANDA #065496
SUPPL-12 CEFUROXIME AXETIL ALKEM LABS LTD Labeling Approval
12/19/2019 DONEPEZIL HYDROCHLORIDE
ANDA #091198
SUPPL-9 DONEPEZIL HYDROCHLORIDE SANDOZ Labeling Approval
12/19/2019 OXALIPLATIN
ANDA #203869
SUPPL-1 OXALIPLATIN JIANGSU HENGRUI MED Labeling Approval
12/19/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #204453
ORIG-3 MINOCYCLINE HYDROCHLORIDE ALKEM LABS LTD Approval
12/19/2019 TAGRISSO
NDA #208065
SUPPL-13 OSIMERTINIB MESYLATE ASTRAZENECA PHARMS Labeling Approval
12/19/2019 ALVIMOPAN
ANDA #208295
ORIG-1 ALVIMOPAN WATSON LABS TEVA Approval
12/19/2019 FIASP
NDA #208751
SUPPL-10 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 FIASP
NDA #208751
SUPPL-11 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 FIASP FLEXTOUCH
NDA #208751
SUPPL-10 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 FIASP FLEXTOUCH
NDA #208751
SUPPL-11 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 FIASP PENFILL
NDA #208751
SUPPL-10 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 FIASP PENFILL
NDA #208751
SUPPL-11 INSULIN ASPART NOVO Efficacy Approval
12/19/2019 NORVIR
NDA #209512
SUPPL-6 RITONAVIR ABBVIE INC Labeling Approval
12/19/2019 CONJUPRI
NDA #212895
ORIG-1 LEVAMLODIPINE MALEATE CSPC OUYI Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approval
12/19/2019 RITUXAN HYCELA
BLA #761064
SUPPL-9 RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) GENENTECH INC Approval
12/20/2019 MYCAMINE
NDA #021506
SUPPL-23 MICAFUNGIN SODIUM ASTELLAS Efficacy Approval
12/20/2019 CLOLAR
NDA #021673
SUPPL-26 CLOFARABINE GENZYME Labeling Approval
12/20/2019 VIBRAMYCIN
NDA #050006
SUPPL-92 DOXYCYCLINE PFIZER Labeling Approval
12/20/2019 VIBRAMYCIN
NDA #050007
SUPPL-34 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
12/20/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050467
SUPPL-76 DOXORUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
12/20/2019 VIBRAMYCIN
NDA #050480
SUPPL-58 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
12/20/2019 VIBRA-TABS
NDA #050533
SUPPL-47 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
12/20/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050629
SUPPL-28 DOXORUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
12/20/2019 GLIPIZIDE
ANDA #074387
SUPPL-4 GLIPIZIDE ANI PHARMS INC Labeling Approval
12/20/2019 GLIPIZIDE
ANDA #074497
SUPPL-28 GLIPIZIDE ANI PHARMS INC Labeling Approval
12/20/2019 GLIPIZIDE
ANDA #074497
SUPPL-29 GLIPIZIDE ANI PHARMS INC Labeling Approval
12/20/2019 LEVALBUTEROL HYDROCHLORIDE
ANDA #078171
SUPPL-5 LEVALBUTEROL HYDROCHLORIDE CIPLA Labeling Approval
12/20/2019 ESZOPICLONE
ANDA #091024
SUPPL-3 ESZOPICLONE DR REDDYS LABS LTD Labeling Approval
12/20/2019 ESZOPICLONE
ANDA #091024
SUPPL-4 ESZOPICLONE DR REDDYS LABS LTD Labeling Approval
12/20/2019 ESZOPICLONE
ANDA #091024
SUPPL-5 ESZOPICLONE DR REDDYS LABS LTD Labeling Approval
12/20/2019 AMYVID
NDA #202008
SUPPL-36 FLORBETAPIR F-18 AVID RADIOPHARMS INC Labeling Approval
12/20/2019 GENOSYL
NDA #202860
ORIG-1 NITRIC OXIDE VERO BIOTECH Type 5 - New Formulation or New Manufacturer Approval
12/20/2019 JUXTAPID
NDA #203858
SUPPL-19 LOMITAPIDE MESYLATE AEGERION Labeling Approval
12/20/2019 QUETIAPINE FUMARATE
ANDA #204253
SUPPL-6 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
12/20/2019 QUETIAPINE FUMARATE
ANDA #204253
SUPPL-10 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
12/20/2019 ONZETRA XSAIL
NDA #206099
SUPPL-6 SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
12/20/2019 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #206137
SUPPL-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL PAR PHARM INC Labeling Approval
12/20/2019 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #206137
SUPPL-3 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL PAR PHARM INC Labeling Approval
12/20/2019 ZOLMITRIPTAN
ANDA #207021
SUPPL-2 ZOLMITRIPTAN AUROBINDO PHARMA LTD Labeling Approval
12/20/2019 QUETIAPINE FUMARATE
ANDA #207655
SUPPL-2 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
12/20/2019 QUETIAPINE FUMARATE
ANDA #207655
SUPPL-4 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
12/20/2019 LEVALBUTEROL HYDROCHLORIDE
ANDA #207820
SUPPL-2 LEVALBUTEROL HYDROCHLORIDE SUN PHARM Labeling Approval
12/20/2019 CAPECITABINE
ANDA #209365
SUPPL-2 CAPECITABINE MSN Labeling Approval
12/20/2019 CAPLYTA
NDA #209500
ORIG-1 LUMATEPERONE TOSYLATE INTRA-CELLULAR Type 1 - New Molecular Entity Approval
12/20/2019 CAPLYTA
NDA #209500
SUPPL-1 LUMATEPERONE TOSYLATE INTRA-CELLULAR Type 1 - New Molecular Entity Approval
12/20/2019 TISSUEBLUE
NDA #209569
ORIG-1 BRILLIANT BLUE G DUTCH OPHTHALMIC Type 1 - New Molecular Entity Approval
12/20/2019 PREVYMIS
NDA #209939
SUPPL-6 LETERMOVIR MERCK SHARP DOHME Labeling Approval
12/20/2019 PREVYMIS
NDA #209940
SUPPL-4 LETERMOVIR MERCK SHARP DOHME Labeling Approval
12/20/2019 TRAVOPROST
ANDA #210458
ORIG-1 TRAVOPROST ALEMBIC PHARMS LTD Approval
12/20/2019 DIAZOXIDE
ANDA #211050
ORIG-1 DIAZOXIDE E5 PHARMA INC Approval
12/20/2019 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ANDA #211190
ORIG-1 DEXTROSE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
12/20/2019 PANTOPRAZOLE SODIUM
ANDA #211368
SUPPL-2 PANTOPRAZOLE SODIUM INGENUS PHARMS LLC Labeling Approval
12/20/2019 DAYVIGO
NDA #212028
ORIG-1 LEMBOREXANT EISAI INC Type 1 - New Molecular Entity Approval
12/20/2019 EVENITY
BLA #761062
SUPPL-2 ROMOSOZUMAB-AQQG AMGEN INC Approval
12/20/2019 ENHERTU
BLA #761139
ORIG-1 FAM-TRASTUZUMAB DERUXTECAN-NXKI DAIICHI SANKYO Approval
12/22/2019 RISPERIDONE
ANDA #090839
SUPPL-8 RISPERIDONE JUBILANT GENERICS Labeling Approval
12/22/2019 RISPERIDONE
ANDA #090839
SUPPL-9 RISPERIDONE JUBILANT GENERICS Labeling Approval
12/22/2019 RISPERIDONE
ANDA #090839
SUPPL-13 RISPERIDONE JUBILANT GENERICS Labeling Approval
12/23/2019 DEPO-SUBQ PROVERA 104
NDA #021583
SUPPL-16 MEDROXYPROGESTERONE ACETATE PHARMACIA AND UPJOHN Labeling Approval
12/23/2019 DEPO-SUBQ PROVERA 104
NDA #021583
SUPPL-24 MEDROXYPROGESTERONE ACETATE PHARMACIA AND UPJOHN Labeling Approval
12/23/2019 DEPO-SUBQ PROVERA 104
NDA #021583
SUPPL-29 MEDROXYPROGESTERONE ACETATE PHARMACIA AND UPJOHN Labeling Approval
12/23/2019 CARBAGLU
NDA #022562
SUPPL-11 CARGLUMIC ACID RECORDATI RARE Labeling Approval
12/23/2019 AZITHROMYCIN
ANDA #065400
SUPPL-5 AZITHROMYCIN LUPIN LTD Labeling Approval
12/23/2019 AZITHROMYCIN
ANDA #065400
SUPPL-10 AZITHROMYCIN LUPIN LTD Labeling Approval
12/23/2019 PIROXICAM
ANDA #074116
SUPPL-10 PIROXICAM NOSTRUM LABS INC Labeling Approval
12/23/2019 PIROXICAM
ANDA #074116
SUPPL-12 PIROXICAM NOSTRUM LABS INC Labeling Approval
12/23/2019 PIROXICAM
ANDA #074118
SUPPL-10 PIROXICAM NOSTRUM LABS INC Labeling Approval
12/23/2019 PIROXICAM
ANDA #074118
SUPPL-12 PIROXICAM NOSTRUM LABS INC Labeling Approval
12/23/2019 PIROXICAM
ANDA #074131
SUPPL-20 PIROXICAM TEVA Labeling Approval
12/23/2019 PIROXICAM
ANDA #074131
SUPPL-22 PIROXICAM TEVA Labeling Approval
12/23/2019 PIROXICAM
ANDA #074131
SUPPL-24 PIROXICAM TEVA Labeling Approval
12/23/2019 HALOPERIDOL DECANOATE
ANDA #075440
SUPPL-40 HALOPERIDOL DECANOATE MYLAN LABS LTD Labeling Approval
12/23/2019 HALOPERIDOL DECANOATE
ANDA #075440
SUPPL-41 HALOPERIDOL DECANOATE MYLAN LABS LTD Labeling Approval
12/23/2019 HALOPERIDOL DECANOATE
ANDA #075440
SUPPL-45 HALOPERIDOL DECANOATE MYLAN LABS LTD Labeling Approval
12/23/2019 MECLIZINE HYDROCHLORIDE
ANDA #200294
SUPPL-3 MECLIZINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
12/23/2019 MECLIZINE HYDROCHLORIDE
ANDA #200294
SUPPL-5 MECLIZINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
12/23/2019 MECLIZINE HYDROCHLORIDE
ANDA #200294
SUPPL-6 MECLIZINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
12/23/2019 LIOTHYRONINE SODIUM
ANDA #200295
SUPPL-5 LIOTHYRONINE SODIUM SIGMAPHARM LABS LLC Labeling Approval
12/23/2019 MECLIZINE HYDROCHLORIDE
ANDA #202640
SUPPL-2 MECLIZINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
12/23/2019 MECLIZINE HYDROCHLORIDE
ANDA #202640
SUPPL-3 MECLIZINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
12/23/2019 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #202691
SUPPL-1 METHYLPREDNISOLONE SODIUM SUCCINATE HIKMA Labeling Approval
12/23/2019 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #202691
SUPPL-2 METHYLPREDNISOLONE SODIUM SUCCINATE HIKMA Labeling Approval
12/23/2019 GATIFLOXACIN
ANDA #204227
SUPPL-1 GATIFLOXACIN SANDOZ INC Labeling Approval
12/23/2019 PIROXICAM
ANDA #206136
SUPPL-4 PIROXICAM PII Labeling Approval
12/23/2019 ZILRETTA
NDA #208845
SUPPL-7 TRIAMCINOLONE ACETONIDE FLEXION THERAPS INC Efficacy Approval
12/23/2019 ALOGLIPTIN
ANDA #210002
ORIG-1 ALOGLIPTIN BENZOATE INDOCO REMEDIES Tentative Approval
12/23/2019 APIXABAN
ANDA #210013
ORIG-1 APIXABAN MICRO LABS Approval
12/23/2019 APIXABAN
ANDA #210128
ORIG-1 APIXABAN MYLAN Approval
12/23/2019 PIROXICAM
ANDA #210347
SUPPL-2 PIROXICAM STRIDES PHARMA Labeling Approval
12/23/2019 LORATADINE
ANDA #210722
ORIG-1 LORATADINE GRANULES INDIA LTD Approval
12/23/2019 PENICILLAMINE
ANDA #211196
ORIG-1 PENICILLAMINE PAR PHARM INC Approval
12/23/2019 PENICILLAMINE
ANDA #211231
ORIG-1 PENICILLAMINE PAR PHARM INC Approval
12/23/2019 LIOTHYRONINE SODIUM
ANDA #211510
SUPPL-1 LIOTHYRONINE SODIUM TEVA PHARMS USA Labeling Approval
12/23/2019 UBRELVY
NDA #211765
ORIG-1 UBROGEPANT ALLERGAN Type 1 - New Molecular Entity Approval
12/23/2019 CYTARABINE
ANDA #211937
ORIG-1 CYTARABINE GLAND PHARMA LTD Approval
12/23/2019 CYTARABINE
ANDA #211938
ORIG-1 CYTARABINE GLAND PHARMA LTD Approval
12/26/2019 XOLEGEL
NDA #021946
SUPPL-7 KETOCONAZOLE ALMIRALL Labeling Approval
12/26/2019 STAVZOR
NDA #022152
SUPPL-8 VALPROIC ACID BIONPHARMA INC Labeling Approval
12/26/2019 SUMAVEL DOSEPRO
NDA #022239
SUPPL-6 SUMATRIPTAN SUCCINATE ENDO VENTURES LTD Labeling Approval
12/26/2019 GILENYA
NDA #022527
SUPPL-31 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
12/26/2019 OTREXUP
NDA #204824
SUPPL-10 METHOTREXATE ANTARES PHARMA INC Labeling Approval
12/26/2019 OTREXUP PFS
NDA #204824
SUPPL-10 METHOTREXATE ANTARES PHARMA INC Labeling Approval
12/26/2019 ACTICLATE
NDA #205931
SUPPL-4 DOXYCYCLINE HYCLATE ALMIRALL Labeling Approval
12/26/2019 TOBRAMYCIN
ANDA #207136
ORIG-1 TOBRAMYCIN SUN PHARM Approval
12/26/2019 ACTICLATE CAP
NDA #208253
SUPPL-2 DOXYCYCLINE HYCLATE ALMIRALL Labeling Approval
12/26/2019 PREGABALIN
ANDA #210585
ORIG-1 PREGABALIN CSPC OUYI Approval
12/26/2019 ZIPRASIDONE MESYLATE
ANDA #211908
ORIG-1 ZIPRASIDONE MESYLATE GLAND PHARMA LTD Approval
12/26/2019 DIAZEPAM
ANDA #211998
ORIG-1 DIAZEPAM BELOTECA INC Approval
12/26/2019 VALGANCICLOVIR HYDROCHLORIDE
ANDA #212234
ORIG-1 VALGANCICLOVIR HYDROCHLORIDE AJANTA PHARMA LTD Approval
12/26/2019 ARIPIPRAZOLE
ANDA #212870
ORIG-1 ARIPIPRAZOLE VISTAPHARM Approval
12/27/2019 COPAXONE
NDA #020622
SUPPL-107 GLATIRAMER ACETATE TEVA PHARMS USA Labeling Approval
12/27/2019 LEVEMIR
NDA #021536
SUPPL-56 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
12/27/2019 LEVEMIR FLEXPEN
NDA #021536
SUPPL-56 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
12/27/2019 LEVEMIR FLEXTOUCH
NDA #021536
SUPPL-56 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
12/27/2019 LEVEMIR INNOLET
NDA #021536
SUPPL-56 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
12/27/2019 LEVEMIR PENFILL
NDA #021536
SUPPL-56 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
12/27/2019 INTUNIV
NDA #022037
SUPPL-19 GUANFACINE HYDROCHLORIDE SHIRE Labeling Approval
12/27/2019 ZIDOVUDINE
NDA #200732
SUPPL-2 ZIDOVUDINE MATRIX LABS LTD Labeling Approval
12/27/2019 RAYOS
NDA #202020
SUPPL-12 PREDNISONE HORIZON PHARMA USA Labeling Approval
12/27/2019 NICOTINE POLACRILEX
ANDA #203690
SUPPL-22 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
12/27/2019 TEPADINA
NDA #208264
SUPPL-1 THIOTEPA ADIENNE SA Labeling Approval
12/27/2019 LYNPARZA
NDA #208558
SUPPL-10 OLAPARIB ASTRAZENECA PHARMS Efficacy Approval
12/27/2019 MIRABEGRON
ANDA #209446
ORIG-1 MIRABEGRON SAWAI USA Approval
12/27/2019 SYMDEKO (COPACKAGED)
NDA #210491
SUPPL-5 IVACAFTOR; IVACAFTOR, TEZACAFTOR VERTEX PHARMS INC Labeling Approval
12/27/2019 DEFERASIROX
ANDA #210727
ORIG-1 DEFERASIROX AMNEAL PHARMS CO Approval
12/27/2019 DEFERASIROX
ANDA #210727
ORIG-2 DEFERASIROX AMNEAL PHARMS CO Tentative Approval
12/27/2019 DOFETILIDE
ANDA #212410
ORIG-1 DOFETILIDE RICONPHARMA LLC Approval
12/28/2019 NYMALIZE
NDA #203340
SUPPL-12 NIMODIPINE ARBOR PHARMS LLC Labeling Approval
12/30/2019 STALEVO 100
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 STALEVO 125
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 STALEVO 150
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 STALEVO 200
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 STALEVO 50
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 STALEVO 75
NDA #021485
SUPPL-42 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
12/30/2019 CEFOXITIN
ANDA #065238
SUPPL-3 CEFOXITIN SODIUM HIKMA FARMACEUTICA Labeling Approval
12/30/2019 CEFOXITIN
ANDA #065238
SUPPL-5 CEFOXITIN SODIUM HIKMA FARMACEUTICA Labeling Approval
12/30/2019 CEFOXITIN
ANDA #065238
SUPPL-7 CEFOXITIN SODIUM HIKMA FARMACEUTICA Labeling Approval
12/30/2019 DONEPEZIL HYDROCHLORIDE
ANDA #205269
SUPPL-1 DONEPEZIL HYDROCHLORIDE HISUN PHARM HANGZHOU Labeling Approval
12/30/2019 FEBUXOSTAT
ANDA #210292
ORIG-1 FEBUXOSTAT INDOCO REMEDIES Approval
12/30/2019 FEBUXOSTAT
ANDA #210461
ORIG-1 FEBUXOSTAT MSN Approval
12/30/2019 TOLTERODINE TARTRATE
ANDA #210775
ORIG-1 TOLTERODINE TARTRATE INVATECH Approval
12/30/2019 CLOBETASOL PROPIONATE
ANDA #211836
ORIG-1 CLOBETASOL PROPIONATE TORRENT Approval
12/30/2019 BUPIVACAINE HYDROCHLORIDE
ANDA #212822
ORIG-1 BUPIVACAINE HYDROCHLORIDE HUONS Approval
12/30/2019 DEFERASIROX
ANDA #212995
ORIG-1 DEFERASIROX PIRAMAL HLTHCARE UK Approval
12/30/2019 DEFERASIROX
ANDA #212995
ORIG-2 DEFERASIROX PIRAMAL HLTHCARE UK Tentative Approval
12/31/2019 ALPRAZOLAM
ANDA #074112
SUPPL-31 ALPRAZOLAM SANDOZ Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #074174
SUPPL-7 ALPRAZOLAM DAVA INTL INC Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #074215
SUPPL-24 ALPRAZOLAM MYLAN Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #074342
SUPPL-47 ALPRAZOLAM ACTAVIS ELIZABETH Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #074909
SUPPL-25 ALPRAZOLAM SANDOZ Labeling Approval
12/31/2019 ANAGRELIDE HYDROCHLORIDE
ANDA #076683
SUPPL-8 ANAGRELIDE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #077741
SUPPL-3 ALPRAZOLAM APOTEX INC Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #078491
SUPPL-13 ALPRAZOLAM OXFORD PHARMS Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #090248
SUPPL-5 ALPRAZOLAM VINTAGE PHARMS Labeling Approval
12/31/2019 MYCOPHENOLIC ACID
ANDA #091558
SUPPL-8 MYCOPHENOLIC ACID APOTEX INC Labeling Approval
12/31/2019 ALPRAZOLAM
ANDA #203346
SUPPL-2 ALPRAZOLAM AUROBINDO PHARMA LTD Labeling Approval
12/31/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204079
SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE LUPIN LTD Labeling Approval
12/31/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211983
SUPPL-3 LEVOCETIRIZINE DIHYDROCHLORIDE PERRIGO R AND D Manufacturing (CMC) Approval

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