Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 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 August 15, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/01/2019 PACERONE
ANDA #075135
SUPPL-26 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-27 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-35 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-49 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-51 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-52 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 PACERONE
ANDA #075135
SUPPL-54 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/01/2019 NICOTINE POLACRILEX
ANDA #076775
SUPPL-24 NICOTINE POLACRILEX L PERRIGO CO Labeling Approval
11/01/2019 NICOTINE POLACRILEX
ANDA #078325
SUPPL-15 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
11/01/2019 NICOTINE POLACRILEX
ANDA #078326
SUPPL-15 NICOTINE POLACRILEX PERRIGO R AND D Labeling Approval
11/01/2019 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534
SUPPL-46 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
11/01/2019 FABRAZYME
BLA #103979
SUPPL-5306 AGALSIDASE BETA GENZYME Approval
11/01/2019 TESTOSTERONE
ANDA #204570
SUPPL-2 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
11/01/2019 QUINAPRIL HYDROCHLORIDE
ANDA #205823
SUPPL-2 QUINAPRIL HYDROCHLORIDE PRINSTON INC Labeling Approval
11/01/2019 BOSENTAN
ANDA #207760
SUPPL-1 BOSENTAN ZYDUS PHARMS Labeling Approval
11/01/2019 ABIRATERONE ACETATE
ANDA #208446
SUPPL-3 ABIRATERONE ACETATE MYLAN Labeling Approval
11/01/2019 ENDARI
NDA #208587
SUPPL-1 L-GLUTAMINE EMMAUS MEDCL Labeling Approval
11/01/2019 RADICAVA
NDA #209176
SUPPL-9 EDARAVONE MITSUBISHI TANABE Labeling Approval
11/01/2019 BOSENTAN
ANDA #209324
SUPPL-1 BOSENTAN SUN PHARM Labeling Approval
11/01/2019 AMMONIA N 13
ANDA #209507
ORIG-1 AMMONIA N-13 UNIV TX SW MEDCTR Approval
11/01/2019 ATOVAQUONE
ANDA #209685
SUPPL-1 ATOVAQUONE GLENMARK PHARMS Labeling Approval
11/01/2019 ATOVAQUONE
ANDA #209685
SUPPL-2 ATOVAQUONE GLENMARK PHARMS Labeling Approval
11/01/2019 CLARISCAN
ANDA #210016
ORIG-1 GADOTERATE MEGLUMINE GE HEALTHCARE Approval
11/01/2019 DIMETHYL FUMARATE
ANDA #210538
ORIG-1 DIMETHYL FUMARATE ZYDUS PHARMS USA INC Tentative Approval
11/01/2019 LINEZOLID
ANDA #210702
SUPPL-1 LINEZOLID CELLTRION Manufacturing (CMC) Approval
11/01/2019 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #211204
ORIG-1 ERYTHROMYCIN ETHYLSUCCINATE AMNEAL PHARMS Approval
11/01/2019 IBRANCE
NDA #212436
ORIG-1 PALBOCICLIB PFIZER Type 3 - New Dosage Form Approval
11/01/2019 TALICIA
NDA #213004
ORIG-1 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN REDHILL Type 4 - New Combination Approval
11/04/2019 OCTREOTIDE ACETATE
ANDA #075957
SUPPL-28 OCTREOTIDE ACETATE TEVA PHARMS USA Labeling Approval
11/04/2019 OCTREOTIDE ACETATE
ANDA #075959
SUPPL-29 OCTREOTIDE ACETATE TEVA PHARMS USA Labeling Approval
11/04/2019 METFORMIN HYDROCHLORIDE
ANDA #075967
SUPPL-37 METFORMIN HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
11/04/2019 METFORMIN HYDROCHLORIDE
ANDA #075967
SUPPL-38 METFORMIN HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
11/04/2019 MIDODRINE HYDROCHLORIDE
ANDA #076577
SUPPL-8 MIDODRINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
11/04/2019 ZALEPLON
ANDA #077505
SUPPL-1 ZALEPLON CIPLA LTD Labeling Approval
11/04/2019 ZALEPLON
ANDA #077505
SUPPL-2 ZALEPLON CIPLA LTD Labeling Approval
11/04/2019 ZALEPLON
ANDA #077505
SUPPL-3 ZALEPLON CIPLA LTD Labeling Approval
11/04/2019 ATORVASTATIN CALCIUM
ANDA #077575
SUPPL-9 ATORVASTATIN CALCIUM SANDOZ INC Labeling Approval
11/04/2019 ATORVASTATIN CALCIUM
ANDA #077575
SUPPL-11 ATORVASTATIN CALCIUM SANDOZ INC Labeling Approval
11/04/2019 FOSPHENYTOIN SODIUM
ANDA #078052
SUPPL-8 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
11/04/2019 FOSPHENYTOIN SODIUM
ANDA #078052
SUPPL-10 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
11/04/2019 FOSPHENYTOIN SODIUM
ANDA #078052
SUPPL-11 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
11/04/2019 FOSPHENYTOIN SODIUM
ANDA #078052
SUPPL-12 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
11/04/2019 METRONIDAZOLE
ANDA #079065
SUPPL-8 METRONIDAZOLE ALEMBIC PHARMS LTD Labeling Approval
11/04/2019 METRONIDAZOLE
ANDA #079065
SUPPL-10 METRONIDAZOLE ALEMBIC PHARMS LTD Labeling Approval
11/04/2019 ATORVASTATIN CALCIUM
ANDA #090548
SUPPL-23 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #091151
SUPPL-6 ESZOPICLONE MYLAN PHARMS INC Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #091151
SUPPL-8 ESZOPICLONE MYLAN PHARMS INC Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #091151
SUPPL-9 ESZOPICLONE MYLAN PHARMS INC Labeling Approval
11/04/2019 AZELASTINE HYDROCHLORIDE
ANDA #201846
SUPPL-8 AZELASTINE HYDROCHLORIDE APOTEX INC Labeling Approval
11/04/2019 TELMISARTAN
ANDA #204164
SUPPL-2 TELMISARTAN JUBILANT GENERICS Labeling Approval
11/04/2019 BOSENTAN
ANDA #205699
SUPPL-1 BOSENTAN PAR PHARM INC Labeling Approval
11/04/2019 PRASUGREL
ANDA #205790
SUPPL-1 PRASUGREL HYDROCHLORIDE USPHARMA WINDLAS Labeling Approval
11/04/2019 PRASUGREL
ANDA #205790
SUPPL-2 PRASUGREL HYDROCHLORIDE USPHARMA WINDLAS Labeling Approval
11/04/2019 PRASUGREL
ANDA #205888
SUPPL-1 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/04/2019 PRASUGREL
ANDA #205888
SUPPL-2 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/04/2019 PRASUGREL
ANDA #205913
SUPPL-1 PRASUGREL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
11/04/2019 PRASUGREL
ANDA #205987
SUPPL-1 PRASUGREL HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
11/04/2019 PRASUGREL
ANDA #205987
SUPPL-2 PRASUGREL HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
11/04/2019 TELMISARTAN
ANDA #207016
SUPPL-2 TELMISARTAN MICRO LABS Labeling Approval
11/04/2019 BOSENTAN
ANDA #207110
SUPPL-2 BOSENTAN WATSON LABS INC Labeling Approval
11/04/2019 ABIRATERONE ACETATE
ANDA #208327
SUPPL-3 ABIRATERONE ACETATE AMNEAL PHARMS Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #208451
SUPPL-2 ESZOPICLONE AUROBINDO PHARMA LTD Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #208451
SUPPL-3 ESZOPICLONE AUROBINDO PHARMA LTD Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #208451
SUPPL-5 ESZOPICLONE AUROBINDO PHARMA LTD Labeling Approval
11/04/2019 BOSENTAN
ANDA #209742
SUPPL-2 BOSENTAN AMNEAL PHARMS CO Labeling Approval
11/04/2019 ROSUVASTATIN CALCIUM
ANDA #212059
ORIG-1 ROSUVASTATIN CALCIUM ZHEJIANG YONGTAI Approval
11/04/2019 CISATRACURIUM BESYLATE
ANDA #212171
ORIG-1 CISATRACURIUM BESYLATE ZYDUS PHARMS Approval
11/04/2019 ENTECAVIR
ANDA #212201
ORIG-1 ENTECAVIR YAOPHARMA CO LTD Approval
11/04/2019 NALOXONE HYDROCHLORIDE
ANDA #212456
ORIG-1 NALOXONE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
11/04/2019 ZIEXTENZO
BLA #761045
ORIG-1 PEGFILGRASTIM-BMEZ SANDOZ INC Approval
11/05/2019 WELLBUTRIN
NDA #018644
SUPPL-54 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
11/05/2019 WELLBUTRIN SR
NDA #020358
SUPPL-61 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
11/05/2019 ACTONEL
NDA #020835
SUPPL-52 RISEDRONATE SODIUM APIL Labeling Approval
11/05/2019 WELLBUTRIN XL
NDA #021515
SUPPL-40 BUPROPION HYDROCHLORIDE VALEANT INTL Labeling Approval
11/05/2019 MOVIPREP
NDA #021881
SUPPL-20 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE SALIX PHARMS Labeling Approval
11/05/2019 SORILUX
NDA #022563
SUPPL-7 CALCIPOTRIENE MAYNE PHARMA Efficacy Approval
11/05/2019 SORILUX
NDA #022563
SUPPL-8 CALCIPOTRIENE MAYNE PHARMA Labeling Approval
11/05/2019 ERYTHROCIN
NDA #050609
SUPPL-41 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
11/05/2019 METRONIDAZOLE
ANDA #070772
SUPPL-39 METRONIDAZOLE INNOGENIX Labeling Approval
11/05/2019 METRONIDAZOLE
ANDA #070772
SUPPL-41 METRONIDAZOLE INNOGENIX Labeling Approval
11/05/2019 METFORMIN HYDROCHLORIDE
ANDA #076756
SUPPL-4 METFORMIN HYDROCHLORIDE NOSTRUM PHARMS LLC Labeling Approval
11/05/2019 METFORMIN HYDROCHLORIDE
ANDA #076756
SUPPL-7 METFORMIN HYDROCHLORIDE NOSTRUM PHARMS LLC Labeling Approval
11/05/2019 CYRAMZA
BLA #125477
SUPPL-35 RAMUCIRUMAB ELI LILLY AND CO Approval
11/05/2019 MONTELUKAST SODIUM
ANDA #202096
SUPPL-18 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/05/2019 MONTELUKAST SODIUM
ANDA #202096
SUPPL-21 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/05/2019 KORLYM
NDA #202107
SUPPL-8 MIFEPRISTONE CORCEPT THERAP Labeling Approval
11/05/2019 MONTELUKAST SODIUM
ANDA #202468
SUPPL-20 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/05/2019 MONTELUKAST SODIUM
ANDA #202468
SUPPL-23 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/05/2019 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203040
SUPPL-4 LIDOCAINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/05/2019 TELMISARTAN
ANDA #204415
SUPPL-3 TELMISARTAN AMNEAL PHARMS Labeling Approval
11/05/2019 METFORMIN HYDROCHLORIDE
ANDA #205330
SUPPL-4 METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/05/2019 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #205531
SUPPL-1 METRONIDAZOLE MYLAN LABS LTD Labeling Approval
11/05/2019 METFORMIN HYDROCHLORIDE
ANDA #206955
SUPPL-3 METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/05/2019 METFORMIN HYDROCHLORIDE
ANDA #206955
SUPPL-10 METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/05/2019 ERLOTINIB HYDROCHLORIDE
ANDA #208396
ORIG-1 ERLOTINIB HYDROCHLORIDE APOTEX Approval
11/05/2019 ERLOTINIB HYDROCHLORIDE
ANDA #208488
ORIG-1 ERLOTINIB HYDROCHLORIDE NATCO PHARMA LTD Approval
11/05/2019 EPINEPHRINE (COPACKAGED)
NDA #209359
ORIG-1 EPINEPHRINE HOSPIRA INC Type 7 - Drug Already Marketed without Approved NDA Approval
11/05/2019 ERLOTINIB HYDROCHLORIDE
ANDA #210300
ORIG-1 ERLOTINIB HYDROCHLORIDE SUN PHARM Approval
11/05/2019 ABSORICA LD
NDA #211913
ORIG-1 ISOTRETINOIN SUN PHARM Approval
11/05/2019 ERLOTINIB HYDROCHLORIDE
ANDA #211960
ORIG-1 ERLOTINIB HYDROCHLORIDE SHILPA MEDICARE LTD Approval
11/05/2019 ZILEUTON
ANDA #211972
ORIG-1 ZILEUTON LUPIN LTD Approval
11/06/2019 BARACLUDE
NDA #021797
SUPPL-23 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
11/06/2019 BARACLUDE
NDA #021798
SUPPL-24 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
11/06/2019 VPRIV
BLA #022575
SUPPL-23 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
11/06/2019 MOXATAG
NDA #050813
SUPPL-8 AMOXICILLIN PRAGMA Labeling Approval
11/06/2019 NAPROXEN
ANDA #075227
SUPPL-17 NAPROXEN TEVA Labeling Approval
11/06/2019 NAPROXEN
ANDA #075227
SUPPL-18 NAPROXEN TEVA Labeling Approval
11/06/2019 NAPROXEN
ANDA #075227
SUPPL-20 NAPROXEN TEVA Labeling Approval
11/06/2019 QUINARETIC
ANDA #076374
SUPPL-10 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
11/06/2019 QUINAPRIL HYDROCHLORIDE
ANDA #078457
SUPPL-11 QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
11/06/2019 FOSPHENYTOIN SODIUM
ANDA #078736
SUPPL-5 FOSPHENYTOIN SODIUM MYLAN LABS LTD Labeling Approval
11/06/2019 FOSPHENYTOIN SODIUM
ANDA #078736
SUPPL-8 FOSPHENYTOIN SODIUM MYLAN LABS LTD Labeling Approval
11/06/2019 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513
SUPPL-76 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE MYLAN Labeling Approval
11/06/2019 CLOPIDOGREL BISULFATE
ANDA #090844
SUPPL-8 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
11/06/2019 CLOPIDOGREL BISULFATE
ANDA #090844
SUPPL-9 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
11/06/2019 CLOPIDOGREL BISULFATE
ANDA #090844
SUPPL-10 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
11/06/2019 CLOPIDOGREL BISULFATE
ANDA #090844
SUPPL-12 CLOPIDOGREL BISULFATE TORRENT PHARMS LTD Labeling Approval
11/06/2019 NAPROXEN SODIUM
ANDA #091353
SUPPL-15 NAPROXEN SODIUM GRANULES INDIA Manufacturing (CMC) Approval
11/06/2019 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #200465
SUPPL-6 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM MYLAN Labeling Approval
11/06/2019 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201192
SUPPL-6 HYDROCHLOROTHIAZIDE; TELMISARTAN TORRENT Labeling Approval
11/06/2019 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356
SUPPL-11 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
11/06/2019 GUANFACINE HYDROCHLORIDE
ANDA #201382
SUPPL-3 GUANFACINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/06/2019 GUANFACINE HYDROCHLORIDE
ANDA #201382
SUPPL-4 GUANFACINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/06/2019 GUANFACINE HYDROCHLORIDE
ANDA #201382
SUPPL-5 GUANFACINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/06/2019 GUANFACINE HYDROCHLORIDE
ANDA #201382
SUPPL-6 GUANFACINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/06/2019 FOLIC ACID
ANDA #202522
ORIG-1 FOLIC ACID XGEN PHARMS Approval
11/06/2019 IRBESARTAN
ANDA #202910
SUPPL-10 IRBESARTAN HETERO LABS LTD V Labeling Approval
11/06/2019 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203010
SUPPL-11 HYDROCHLOROTHIAZIDE; TELMISARTAN ALEMBIC PHARMS LTD Labeling Approval
11/06/2019 VALSARTAN
ANDA #203311
SUPPL-3 VALSARTAN HETERO LABS LTD V Labeling Approval
11/06/2019 VALSARTAN
ANDA #203311
SUPPL-5 VALSARTAN HETERO LABS LTD V Labeling Approval
11/06/2019 VALSARTAN
ANDA #203311
SUPPL-9 VALSARTAN HETERO LABS LTD V Labeling Approval
11/06/2019 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204169
SUPPL-7 HYDROCHLOROTHIAZIDE; TELMISARTAN MACLEODS PHARMS LTD Labeling Approval
11/06/2019 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204221
SUPPL-1 HYDROCHLOROTHIAZIDE; TELMISARTAN ZYDUS PHARMS Labeling Approval
11/06/2019 VALSARTAN
ANDA #205536
SUPPL-2 VALSARTAN ALKEM LABS LTD Labeling Approval
11/06/2019 AMBRISENTAN
ANDA #208441
SUPPL-1 AMBRISENTAN MYLAN Labeling Approval
11/06/2019 BOSENTAN
ANDA #208695
SUPPL-2 BOSENTAN HIKMA Labeling Approval
11/06/2019 ALOSETRON HYDROCHLORIDE
ANDA #209180
SUPPL-1 ALOSETRON HYDROCHLORIDE RISING Labeling Approval
11/06/2019 DIAZEPAM
ANDA #210363
SUPPL-1 DIAZEPAM BELOTECA INC Labeling Approval
11/06/2019 AMBRISENTAN
ANDA #210715
SUPPL-1 AMBRISENTAN CIPLA Labeling Approval
11/06/2019 AMBRISENTAN
ANDA #210784
SUPPL-1 AMBRISENTAN SUN PHARM Labeling Approval
11/07/2019 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950
SUPPL-66 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950
SUPPL-67 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950
SUPPL-66 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950
SUPPL-67 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950
SUPPL-66 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950
SUPPL-67 FLUCONAZOLE PFIZER Labeling Approval
11/07/2019 HYZAAR
NDA #020387
SUPPL-64 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MERCK SHARP DOHME Labeling Approval
11/07/2019 CHILDREN'S CLARITIN
NDA #021891
SUPPL-32 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
11/07/2019 CLARITIN
NDA #021891
SUPPL-32 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
11/07/2019 ABSORICA
NDA #021951
SUPPL-13 ISOTRETINOIN SUN PHARM INDS INC Labeling Approval
11/07/2019 ALLOPURINOL
ANDA #075798
SUPPL-21 ALLOPURINOL VINTAGE PHARMS Labeling Approval
11/07/2019 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483
SUPPL-9 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
11/07/2019 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #077483
SUPPL-10 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SUN PHARM INDS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926
SUPPL-4 MONTELUKAST SODIUM GLENMARK GENERICS Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926
SUPPL-6 MONTELUKAST SODIUM GLENMARK GENERICS Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926
SUPPL-8 MONTELUKAST SODIUM GLENMARK GENERICS Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926
SUPPL-11 MONTELUKAST SODIUM GLENMARK GENERICS Labeling Approval
11/07/2019 ESZOPICLONE
ANDA #091169
SUPPL-3 ESZOPICLONE TEVA Labeling Approval
11/07/2019 ESZOPICLONE
ANDA #091169
SUPPL-7 ESZOPICLONE TEVA Labeling Approval
11/07/2019 ESZOPICLONE
ANDA #091169
SUPPL-8 ESZOPICLONE TEVA Labeling Approval
11/07/2019 ESZOPICLONE
ANDA #091169
SUPPL-10 ESZOPICLONE TEVA Labeling Approval
11/07/2019 STELARA
BLA #125261
SUPPL-142 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202717
SUPPL-14 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202717
SUPPL-15 MONTELUKAST SODIUM ACCORD HLTHCARE Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202906
SUPPL-6 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202906
SUPPL-7 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202906
SUPPL-10 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202906
SUPPL-11 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #202906
SUPPL-12 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
11/07/2019 ZONTIVITY
NDA #204886
SUPPL-5 VORAPAXAR SULFATE TOPROL Labeling Approval
11/07/2019 ATORVASTATIN CALCIUM
ANDA #205945
ORIG-1 ATORVASTATIN CALCIUM MICRO LABS LTD INDIA Approval
11/07/2019 ATOVAQUONE
ANDA #207833
SUPPL-1 ATOVAQUONE PADDOCK LLC Labeling Approval
11/07/2019 ATOVAQUONE
ANDA #207833
SUPPL-2 ATOVAQUONE PADDOCK LLC Labeling Approval
11/07/2019 BORTEZOMIB
ANDA #208460
ORIG-1 BORTEZOMIB HOSPIRA INC Tentative Approval
11/07/2019 BENZNIDAZOLE
NDA #209570
SUPPL-1 BENZNIDAZOLE CHEMO RESEARCH SL Labeling Approval
11/07/2019 EXEM FOAM KIT
NDA #212279
ORIG-1 AIR POLYMER-TYPE A GISKIT Type 1 - New Molecular Entity Approval
11/07/2019 STELARA
BLA #761044
SUPPL-1 USTEKINUMAB JANSSEN BIOTECH Approval
11/08/2019 PROVOCHOLINE
NDA #019193
SUPPL-21 METHACHOLINE CHLORIDE METHAPHARM Efficacy Approval
11/08/2019 SUPPRELIN LA
NDA #022058
SUPPL-16 HISTRELIN ACETATE ENDO PHARM Labeling Approval
11/08/2019 FAMOTIDINE
ANDA #075610
SUPPL-9 FAMOTIDINE APOTEX Labeling Approval
11/08/2019 FAMOTIDINE
ANDA #075610
SUPPL-10 FAMOTIDINE APOTEX Labeling Approval
11/08/2019 METFORMIN HYDROCHLORIDE
ANDA #076873
SUPPL-8 METFORMIN HYDROCHLORIDE SANDOZ Labeling Approval
11/08/2019 METFORMIN HYDROCHLORIDE
ANDA #076873
SUPPL-9 METFORMIN HYDROCHLORIDE SANDOZ Labeling Approval
11/08/2019 FAMOTIDINE
ANDA #077367
SUPPL-17 FAMOTIDINE DR REDDYS LABS LTD Labeling Approval
11/08/2019 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #078084
SUPPL-11 METRONIDAZOLE BAXTER HLTHCARE CORP Labeling Approval
11/08/2019 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #078084
SUPPL-14 METRONIDAZOLE BAXTER HLTHCARE CORP Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #090955
SUPPL-10 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #090955
SUPPL-12 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #090955
SUPPL-13 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203328
SUPPL-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203328
SUPPL-7 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203328
SUPPL-8 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203366
SUPPL-13 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203366
SUPPL-16 MONTELUKAST SODIUM MACLEODS PHARMS LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203432
SUPPL-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203432
SUPPL-5 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203432
SUPPL-7 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203438
SUPPL-1 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203438
SUPPL-6 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 MONTELUKAST SODIUM
ANDA #203438
SUPPL-10 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
11/08/2019 DORZOLAMIDE HYDROCHLORIDE
ANDA #204778
ORIG-1 DORZOLAMIDE HYDROCHLORIDE MICRO LABS Approval
11/08/2019 PROPOFOL
ANDA #205307
SUPPL-1 PROPOFOL WATSON LABS INC Labeling Approval
11/08/2019 ADAPALENE AND BENZOYL PEROXIDE
ANDA #208108
ORIG-1 ADAPALENE; BENZOYL PEROXIDE GLENMARK PHARMS LTD Approval
11/08/2019 BENDEKA
NDA #208194
SUPPL-20 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
11/08/2019 REBLOZYL
BLA #761136
ORIG-1 LUSPATERCEPT-AAMT CELGENE CORP Approval
11/12/2019 INDOMETHACIN
ANDA #070673
SUPPL-20 INDOMETHACIN SANDOZ Labeling Approval
11/12/2019 INDOMETHACIN
ANDA #070673
SUPPL-21 INDOMETHACIN SANDOZ Labeling Approval
11/12/2019 INDOMETHACIN
ANDA #070674
SUPPL-20 INDOMETHACIN SANDOZ Labeling Approval
11/12/2019 INDOMETHACIN
ANDA #070674
SUPPL-21 INDOMETHACIN SANDOZ Labeling Approval
11/12/2019 RISPERIDONE
ANDA #078871
SUPPL-5 RISPERIDONE CELLTRION Labeling Approval
11/12/2019 RISPERIDONE
ANDA #078871
SUPPL-6 RISPERIDONE CELLTRION Labeling Approval
11/12/2019 RISPERIDONE
ANDA #078871
SUPPL-7 RISPERIDONE CELLTRION Labeling Approval
11/12/2019 DAPTOMYCIN
ANDA #091039
SUPPL-2 DAPTOMYCIN TEVA PHARMS USA Labeling Approval
11/12/2019 DAPTOMYCIN
ANDA #091039
SUPPL-3 DAPTOMYCIN TEVA PHARMS USA Labeling Approval
11/12/2019 DAPTOMYCIN
ANDA #091039
SUPPL-4 DAPTOMYCIN TEVA PHARMS USA Labeling Approval
11/12/2019 ESZOPICLONE
ANDA #091166
SUPPL-4 ESZOPICLONE GLENMARK GENERICS Labeling Approval
11/12/2019 ESZOPICLONE
ANDA #091166
SUPPL-5 ESZOPICLONE GLENMARK GENERICS Labeling Approval
11/12/2019 ESZOPICLONE
ANDA #091166
SUPPL-6 ESZOPICLONE GLENMARK GENERICS Labeling Approval
11/12/2019 RISPERIDONE
ANDA #201003
SUPPL-10 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
11/12/2019 RISPERIDONE
ANDA #201003
SUPPL-14 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
11/12/2019 RISPERIDONE
ANDA #201003
SUPPL-16 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
11/12/2019 ITRACONAZOLE
ANDA #205724
SUPPL-1 ITRACONAZOLE PAR PHARM INC Labeling Approval
11/12/2019 ITRACONAZOLE
ANDA #205724
SUPPL-2 ITRACONAZOLE PAR PHARM INC Labeling Approval
11/12/2019 ITRACONAZOLE
ANDA #205724
SUPPL-4 ITRACONAZOLE PAR PHARM INC Labeling Approval
11/13/2019 PROPAFENONE HYDROCHLORIDE
ANDA #075203
SUPPL-17 PROPAFENONE HYDROCHLORIDE WATSON LABS Labeling Approval
11/13/2019 MIDODRINE HYDROCHLORIDE
ANDA #076449
SUPPL-14 MIDODRINE HYDROCHLORIDE IMPAX PHARMS Labeling Approval
11/13/2019 ORVATEN
ANDA #076725
SUPPL-17 MIDODRINE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/13/2019 MIDODRINE HYDROCHLORIDE
ANDA #077746
SUPPL-7 MIDODRINE HYDROCHLORIDE APOTEX Labeling Approval
11/13/2019 MELOXICAM
ANDA #077938
SUPPL-4 MELOXICAM PURACAP PHARM Labeling Approval
11/13/2019 PROCAINAMIDE HYDROCHLORIDE
ANDA #088636
SUPPL-15 PROCAINAMIDE HYDROCHLORIDE INTL MEDICATION Labeling Approval
11/13/2019 PANTOPRAZOLE SODIUM
ANDA #090807
SUPPL-5 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
11/13/2019 PANTOPRAZOLE SODIUM
ANDA #090807
SUPPL-6 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
11/13/2019 PANTOPRAZOLE SODIUM
ANDA #090807
SUPPL-7 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
11/13/2019 PANTOPRAZOLE SODIUM
ANDA #090807
SUPPL-8 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
11/13/2019 PANTOPRAZOLE SODIUM
ANDA #090807
SUPPL-9 PANTOPRAZOLE SODIUM RUBICON Labeling Approval
11/13/2019 PROPAFENONE HYDROCHLORIDE
ANDA #202445
SUPPL-1 PROPAFENONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/13/2019 LUMASON
NDA #203684
SUPPL-5 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES BRACCO Efficacy Approval
11/13/2019 MIDAZOLAM HYDROCHLORIDE
ANDA #208878
SUPPL-1 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/14/2019 EMEND
NDA #021549
SUPPL-30 APREPITANT MERCK Labeling Approval
11/14/2019 EMEND
NDA #022023
SUPPL-19 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Labeling Approval
11/14/2019 OXYCONTIN
NDA #022272
SUPPL-42 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
11/14/2019 SPIRONOLACTONE
ANDA #040424
SUPPL-21 SPIRONOLACTONE MYLAN Labeling Approval
11/14/2019 DIFLORASONE DIACETATE
ANDA #075374
SUPPL-11 DIFLORASONE DIACETATE FOUGERA PHARMS Labeling Approval
11/14/2019 DIFLORASONE DIACETATE
ANDA #075374
SUPPL-12 DIFLORASONE DIACETATE FOUGERA PHARMS Labeling Approval
11/14/2019 CLOBETASOL PROPIONATE (EMOLLIENT)
ANDA #075633
SUPPL-10 CLOBETASOL PROPIONATE TARO Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075969
SUPPL-11 METFORMIN HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075969
SUPPL-12 METFORMIN HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075976
SUPPL-20 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075976
SUPPL-21 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #076650
SUPPL-7 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #076650
SUPPL-8 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #077113
SUPPL-8 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #077113
SUPPL-9 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2019 FLUTICASONE PROPIONATE
ANDA #077570
SUPPL-13 FLUTICASONE PROPIONATE HI TECH PHARMA Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #077619
SUPPL-11 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #077619
SUPPL-12 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #077619
SUPPL-13 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #077619
SUPPL-14 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #077619
SUPPL-15 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
11/14/2019 CLOBETASOL PROPIONATE
ANDA #077763
SUPPL-11 CLOBETASOL PROPIONATE PERRIGO ISRAEL Labeling Approval
11/14/2019 CLOBETASOL PROPIONATE
ANDA #077763
SUPPL-13 CLOBETASOL PROPIONATE PERRIGO ISRAEL Labeling Approval
11/14/2019 TEMOZOLOMIDE
ANDA #078879
SUPPL-15 TEMOZOLOMIDE BARR Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #090074
SUPPL-16 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #090074
SUPPL-18 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #090074
SUPPL-19 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #090074
SUPPL-22 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
11/14/2019 DIDANOSINE
ANDA #090094
SUPPL-13 DIDANOSINE AUROBINDO PHARMA Labeling Approval
11/14/2019 DIDANOSINE
ANDA #090094
SUPPL-14 DIDANOSINE AUROBINDO PHARMA Labeling Approval
11/14/2019 FLUTICASONE PROPIONATE
ANDA #090759
SUPPL-3 FLUTICASONE PROPIONATE GLENMARK GENERICS Labeling Approval
11/14/2019 FLUTICASONE PROPIONATE
ANDA #090759
SUPPL-5 FLUTICASONE PROPIONATE GLENMARK GENERICS Labeling Approval
11/14/2019 QUETIAPINE FUMARATE
ANDA #090960
SUPPL-10 QUETIAPINE FUMARATE ZENNOVA Labeling Approval
11/14/2019 QUETIAPINE FUMARATE
ANDA #090960
SUPPL-11 QUETIAPINE FUMARATE ZENNOVA Labeling Approval
11/14/2019 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189
SUPPL-4 METHAMPHETAMINE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
11/14/2019 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189
SUPPL-5 METHAMPHETAMINE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
11/14/2019 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189
SUPPL-6 METHAMPHETAMINE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
11/14/2019 WARFARIN SODIUM
ANDA #200104
SUPPL-1 WARFARIN SODIUM IPCA LABS LTD Labeling Approval
11/14/2019 WARFARIN SODIUM
ANDA #200104
SUPPL-2 WARFARIN SODIUM IPCA LABS LTD Labeling Approval
11/14/2019 WARFARIN SODIUM
ANDA #200104
SUPPL-4 WARFARIN SODIUM IPCA LABS LTD Labeling Approval
11/14/2019 WARFARIN SODIUM
ANDA #200104
SUPPL-5 WARFARIN SODIUM IPCA LABS LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #202038
SUPPL-10 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #202038
SUPPL-12 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #202038
SUPPL-13 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #202038
SUPPL-15 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/14/2019 PANTOPRAZOLE SODIUM
ANDA #202038
SUPPL-18 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/14/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202063
SUPPL-7 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/14/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202063
SUPPL-8 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/14/2019 GEMCITABINE HYDROCHLORIDE
ANDA #202063
SUPPL-9 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/14/2019 FUROSEMIDE
ANDA #202747
SUPPL-3 FUROSEMIDE BAXTER HLTHCARE CORP Labeling Approval
11/14/2019 SPIRONOLACTONE
ANDA #203253
SUPPL-5 SPIRONOLACTONE JUBILANT GENERICS Labeling Approval
11/14/2019 DOXERCALCIFEROL
ANDA #203875
ORIG-1 DOXERCALCIFEROL SUN PHARM Approval
11/14/2019 PROPAFENONE HYDROCHLORIDE
ANDA #205956
SUPPL-3 PROPAFENONE HYDROCHLORIDE WILSHIRE PHARMS INC Labeling Approval
11/14/2019 ROPIVACAINE HYDROCHLORIDE
ANDA #206166
SUPPL-3 ROPIVACAINE HYDROCHLORIDE INFORLIFE Labeling Approval
11/14/2019 HYSINGLA ER
NDA #206627
SUPPL-9 HYDROCODONE BITARTRATE PURDUE PHARMA LP REMS Approval
11/14/2019 EMEND
NDA #207865
SUPPL-3 APREPITANT MSD MERCK CO Labeling Approval
11/14/2019 MIGLUSTAT
ANDA #208342
SUPPL-1 MIGLUSTAT AMERIGEN PHARMS LTD Labeling Approval
11/14/2019 CELECOXIB
ANDA #208701
ORIG-1 CELECOXIB CADILA PHARMS LTD Approval
11/14/2019 METFORMIN HYDROCHLORIDE
ANDA #209303
SUPPL-2 METFORMIN HYDROCHLORIDE ALIGNSCIENCE PHARMA Labeling Approval
11/14/2019 FETROJA
NDA #209445
ORIG-1 CEFIDEROCOL SULFATE TOSYLATE SHIONOGI INC Type 1 - New Molecular Entity Approval
11/14/2019 BUSPIRONE HYDROCHLORIDE
ANDA #210907
ORIG-1 BUSPIRONE HYDROCHLORIDE UNICHEM LABS LTD Approval
11/14/2019 COLCHICINE
ANDA #211519
SUPPL-1 COLCHICINE ZYDUS PHARMS Manufacturing (CMC) Approval
11/14/2019 BRUKINSA
NDA #213217
ORIG-1 ZANUBRUTINIB BEIGENE Type 1 - New Molecular Entity Approval
11/15/2019 HUMULIN R
BLA #018780
SUPPL-175 INSULIN HUMAN LILLY Approval
11/15/2019 HUMULIN R
BLA #018780
SUPPL-176 INSULIN HUMAN LILLY Approval
11/15/2019 HUMULIN R
BLA #018780
SUPPL-175 INSULIN RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN R
BLA #018780
SUPPL-176 INSULIN RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN R KWIKPEN
BLA #018780
SUPPL-175 INSULIN HUMAN LILLY Approval
11/15/2019 HUMULIN R KWIKPEN
BLA #018780
SUPPL-176 INSULIN HUMAN LILLY Approval
11/15/2019 HUMULIN R PEN
BLA #018780
SUPPL-175 INSULIN RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN R PEN
BLA #018780
SUPPL-176 INSULIN RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN N
BLA #018781
SUPPL-187 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN N
BLA #018781
SUPPL-188 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN 70/30
BLA #019717
SUPPL-168 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN 70/30
BLA #019717
SUPPL-169 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN 70/30 PEN
BLA #019717
SUPPL-168 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 HUMULIN 70/30 PEN
BLA #019717
SUPPL-169 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/15/2019 NOVOLIN R
BLA #019938
SUPPL-79 INSULIN RECOMBINANT HUMAN NOVO NORDISK INC Approval
11/15/2019 NOVOLIN N
BLA #019959
SUPPL-82 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
11/15/2019 NOVOLIN 70/30
BLA #019991
SUPPL-82 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
11/15/2019 NICORETTE
NDA #020066
SUPPL-64 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
11/15/2019 NICORETTE (MINT)
NDA #020066
SUPPL-64 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
11/15/2019 HUMALOG
BLA #020563
SUPPL-196 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG
BLA #020563
SUPPL-198 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG
BLA #020563
SUPPL-199 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG KWIKPEN
BLA #020563
SUPPL-196 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG KWIKPEN
BLA #020563
SUPPL-198 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG KWIKPEN
BLA #020563
SUPPL-199 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG PEN
BLA #020563
SUPPL-196 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG PEN
BLA #020563
SUPPL-198 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG PEN
BLA #020563
SUPPL-199 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG TEMPO PEN
BLA #020563
SUPPL-196 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG TEMPO PEN
BLA #020563
SUPPL-198 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG TEMPO PEN
BLA #020563
SUPPL-199 INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 NOVOLOG
BLA #020986
SUPPL-90 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG
BLA #020986
SUPPL-91 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG FLEXPEN
BLA #020986
SUPPL-90 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG FLEXPEN
BLA #020986
SUPPL-91 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG FLEXTOUCH
BLA #020986
SUPPL-90 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG FLEXTOUCH
BLA #020986
SUPPL-91 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG INNOLET
BLA #020986
SUPPL-90 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG INNOLET
BLA #020986
SUPPL-91 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG PENFILL
BLA #020986
SUPPL-90 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG PENFILL
BLA #020986
SUPPL-91 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 HUMALOG MIX 75/25
BLA #021017
SUPPL-141 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 75/25
BLA #021017
SUPPL-143 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 75/25 KWIKPEN
BLA #021017
SUPPL-141 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 75/25 KWIKPEN
BLA #021017
SUPPL-143 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 75/25 PEN
BLA #021017
SUPPL-141 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 75/25 PEN
BLA #021017
SUPPL-143 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50
BLA #021018
SUPPL-127 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50
BLA #021018
SUPPL-129 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50 KWIKPEN
BLA #021018
SUPPL-127 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50 KWIKPEN
BLA #021018
SUPPL-129 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50 PEN
BLA #021018
SUPPL-127 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 HUMALOG MIX 50/50 PEN
BLA #021018
SUPPL-129 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
11/15/2019 LANTUS
BLA #021081
SUPPL-73 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 LANTUS
BLA #021081
SUPPL-74 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 LANTUS SOLOSTAR
BLA #021081
SUPPL-73 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 LANTUS SOLOSTAR
BLA #021081
SUPPL-74 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 NOVOLOG MIX 70/30
BLA #021172
SUPPL-71 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 70/30
BLA #021172
SUPPL-72 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172
SUPPL-71 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172
SUPPL-72 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 70/30 PENFILL
BLA #021172
SUPPL-71 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 70/30 PENFILL
BLA #021172
SUPPL-72 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR
BLA #021536
SUPPL-57 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR
BLA #021536
SUPPL-58 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR FLEXPEN
BLA #021536
SUPPL-57 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR FLEXPEN
BLA #021536
SUPPL-58 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR FLEXTOUCH
BLA #021536
SUPPL-57 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR FLEXTOUCH
BLA #021536
SUPPL-58 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR INNOLET
BLA #021536
SUPPL-57 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR INNOLET
BLA #021536
SUPPL-58 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR PENFILL
BLA #021536
SUPPL-57 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 LEVEMIR PENFILL
BLA #021536
SUPPL-58 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 APIDRA
BLA #021629
SUPPL-39 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 APIDRA
BLA #021629
SUPPL-40 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 APIDRA SOLOSTAR
BLA #021629
SUPPL-39 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 APIDRA SOLOSTAR
BLA #021629
SUPPL-40 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
11/15/2019 NOVOLOG MIX 50/50
BLA #021810
SUPPL-18 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 NOVOLOG MIX 50/50
BLA #021810
SUPPL-19 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
11/15/2019 XARELTO
NDA #022406
SUPPL-27 RIVAROXABAN JANSSEN PHARMS Labeling Approval
11/15/2019 NAPROXEN
ANDA #074190
SUPPL-13 NAPROXEN HIKMA Labeling Approval
11/15/2019 NAPROXEN
ANDA #074190
SUPPL-14 NAPROXEN HIKMA Labeling Approval
11/15/2019 NAPROXEN
ANDA #074190
SUPPL-15 NAPROXEN HIKMA Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #076410
SUPPL-17 ZOLPIDEM TARTRATE TEVA Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #076410
SUPPL-19 ZOLPIDEM TARTRATE TEVA Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #076410
SUPPL-21 ZOLPIDEM TARTRATE TEVA Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #076410
SUPPL-23 ZOLPIDEM TARTRATE TEVA Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #076410
SUPPL-24 ZOLPIDEM TARTRATE TEVA Labeling Approval
11/15/2019 MIRTAZAPINE
ANDA #077376
SUPPL-16 MIRTAZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/15/2019 MIRTAZAPINE
ANDA #077376
SUPPL-17 MIRTAZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/15/2019 MIRTAZAPINE
ANDA #077376
SUPPL-22 MIRTAZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894
SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894
SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920
SUPPL-9 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920
SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920
SUPPL-12 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920
SUPPL-14 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920
SUPPL-15 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151
SUPPL-5 PRAMIPEXOLE DIHYDROCHLORIDE ZENNOVA Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151
SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE ZENNOVA Labeling Approval
11/15/2019 BLISOVI 24 FE
ANDA #091398
SUPPL-14 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN LTD Manufacturing (CMC) Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-2 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-3 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-4 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-5 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-6 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266
SUPPL-7 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #201509
SUPPL-1 ZOLPIDEM TARTRATE PAR FORM Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #201509
SUPPL-2 ZOLPIDEM TARTRATE PAR FORM Labeling Approval
11/15/2019 ENSKYCE
ANDA #201887
SUPPL-15 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Manufacturing (CMC) Approval
11/15/2019 XARELTO
NDA #202439
SUPPL-34 RIVAROXABAN JANSSEN PHARMS Labeling Approval
11/15/2019 RYZODEG 70/30
BLA #203313
SUPPL-9 INSULIN ASPART; INSULIN DEGLUDEC NOVO Approval
11/15/2019 RYZODEG 70/30
BLA #203313
SUPPL-10 INSULIN ASPART; INSULIN DEGLUDEC NOVO Approval
11/15/2019 TRESIBA
BLA #203314
SUPPL-15 INSULIN DEGLUDEC NOVO Approval
11/15/2019 TRESIBA
BLA #203314
SUPPL-16 INSULIN DEGLUDEC NOVO Approval
11/15/2019 RABEPRAZOLE SODIUM
ANDA #204179
SUPPL-2 RABEPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
11/15/2019 RABEPRAZOLE SODIUM
ANDA #204179
SUPPL-3 RABEPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
11/15/2019 RABEPRAZOLE SODIUM
ANDA #204179
SUPPL-4 RABEPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
11/15/2019 RABEPRAZOLE SODIUM
ANDA #204179
SUPPL-5 RABEPRAZOLE SODIUM AMNEAL PHARMS Labeling Approval
11/15/2019 BASAGLAR
BLA #205692
SUPPL-21 INSULIN GLARGINE ELI LILLY AND CO Approval
11/15/2019 BASAGLAR
BLA #205692
SUPPL-24 INSULIN GLARGINE ELI LILLY AND CO Approval
11/15/2019 BASAGLAR
BLA #205692
SUPPL-25 INSULIN GLARGINE ELI LILLY AND CO Approval
11/15/2019 HUMALOG KWIKPEN
BLA #205747
SUPPL-22 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
11/15/2019 HUMALOG KWIKPEN
BLA #205747
SUPPL-25 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
11/15/2019 HUMALOG KWIKPEN
BLA #205747
SUPPL-26 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
11/15/2019 HARVONI
NDA #205834
SUPPL-28 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/15/2019 TOUJEO MAX SOLOSTAR
BLA #206538
SUPPL-13 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/15/2019 TOUJEO MAX SOLOSTAR
BLA #206538
SUPPL-14 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/15/2019 TOUJEO SOLOSTAR
BLA #206538
SUPPL-13 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/15/2019 TOUJEO SOLOSTAR
BLA #206538
SUPPL-14 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/15/2019 DAPTOMYCIN
ANDA #207104
ORIG-1 DAPTOMYCIN SAGENT PHARMS INC Approval
11/15/2019 EPCLUSA
NDA #208341
SUPPL-12 SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC Efficacy Approval
11/15/2019 XULTOPHY 100/3.6
BLA #208583
SUPPL-14 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
11/15/2019 XULTOPHY 100/3.6
BLA #208583
SUPPL-15 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
11/15/2019 SOLIQUA 100/33
BLA #208673
SUPPL-8 INSULIN GLARGINE; LIXISENATIDE SANOFI-AVENTIS US Approval
11/15/2019 SOLIQUA 100/33
BLA #208673
SUPPL-9 INSULIN GLARGINE; LIXISENATIDE SANOFI-AVENTIS US Approval
11/15/2019 FIASP
BLA #208751
SUPPL-12 INSULIN ASPART NOVO Approval
11/15/2019 FIASP FLEXTOUCH
BLA #208751
SUPPL-12 INSULIN ASPART NOVO Approval
11/15/2019 FIASP PENFILL
BLA #208751
SUPPL-12 INSULIN ASPART NOVO Approval
11/15/2019 VOSEVI
NDA #209195
SUPPL-3 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR GILEAD SCIENCES INC Efficacy Approval
11/15/2019 ADMELOG
BLA #209196
SUPPL-4 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/15/2019 ADMELOG
BLA #209196
SUPPL-5 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/15/2019 ADMELOG SOLOSTAR
BLA #209196
SUPPL-4 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/15/2019 ADMELOG SOLOSTAR
BLA #209196
SUPPL-5 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/15/2019 CLOBETASOL PROPIONATE
ANDA #211295
ORIG-1 CLOBETASOL PROPIONATE ENCUBE Approval
11/15/2019 PREDNISONE
ANDA #211575
ORIG-1 PREDNISONE NOVITIUM PHARMA Approval
11/15/2019 APREMILAST
ANDA #211756
ORIG-1 APREMILAST DR REDDYS LABS INC Tentative Approval
11/15/2019 APREMILAST
ANDA #211859
ORIG-1 APREMILAST ZYDUS PHARMS USA INC Tentative Approval
11/15/2019 HARVONI
NDA #212477
SUPPL-2 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/15/2019 ABRILADA
BLA #761118
ORIG-1 ADALIMUMAB-AFZB PFIZER INC Approval
11/15/2019 ADAKVEO
BLA #761128
ORIG-1 CRIZANLIZUMAB-TMCA NOVARTIS PHARMS CORP Approval
11/16/2019 CEFUROXIME SODIUM
ANDA #065046
SUPPL-11 CEFUROXIME SODIUM HIKMA FARMACEUTICA Labeling Approval
11/16/2019 CEFUROXIME
ANDA #065048
SUPPL-17 CEFUROXIME HIKMA FARMACEUTICA Labeling Approval
11/16/2019 CEFUROXIME SODIUM
ANDA #065048
SUPPL-17 CEFUROXIME SODIUM HIKMA FARMACEUTICA Labeling Approval
11/16/2019 AMPICILLIN AND SULBACTAM
ANDA #065176
SUPPL-14 AMPICILLIN SODIUM; SULBACTAM SODIUM HANFORD GC Labeling Approval
11/16/2019 AMPICILLIN AND SULBACTAM
ANDA #065188
SUPPL-16 AMPICILLIN SODIUM; SULBACTAM SODIUM HANFORD GC Labeling Approval
11/18/2019 TYLENOL W/ CODEINE NO. 1
ANDA #085055
SUPPL-63 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
11/18/2019 TYLENOL W/ CODEINE NO. 2
ANDA #085055
SUPPL-63 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
11/18/2019 TYLENOL W/ CODEINE NO. 3
ANDA #085055
SUPPL-63 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
11/18/2019 TYLENOL W/ CODEINE NO. 4
ANDA #085055
SUPPL-63 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
11/18/2019 AMPICILLIN SODIUM
ANDA #090581
SUPPL-3 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling Approval
11/18/2019 TACROLIMUS
ANDA #090802
SUPPL-7 TACROLIMUS PANACEA BIOTEC LTD Labeling Approval
11/18/2019 ECOZA
NDA #205175
SUPPL-3 ECONAZOLE NITRATE GLENMARK Labeling Approval
11/18/2019 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #205199
ORIG-1 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM APOTEX Approval
11/18/2019 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #207316
ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE VITRUVIAS THERAP Approval
11/18/2019 DILTIAZEM HYDROCHLORIDE
ANDA #211596
ORIG-1 DILTIAZEM HYDROCHLORIDE EDENBRIDGE PHARMS Approval
11/18/2019 IRINOTECAN HYDROCHLORIDE
ANDA #212993
ORIG-1 IRINOTECAN HYDROCHLORIDE GLAND PHARMA LTD Approval
11/19/2019 RITALIN
NDA #010187
SUPPL-91 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
11/19/2019 RITALIN-SR
NDA #018029
SUPPL-59 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
11/19/2019 FOCALIN
NDA #021278
SUPPL-26 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
11/19/2019 RITALIN LA
NDA #021284
SUPPL-41 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
11/19/2019 FOCALIN XR
NDA #021802
SUPPL-36 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322
SUPPL-15 ZOLPIDEM TARTRATE SANDOZ INC Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322
SUPPL-16 ZOLPIDEM TARTRATE SANDOZ INC Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322
SUPPL-17 ZOLPIDEM TARTRATE SANDOZ INC Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322
SUPPL-18 ZOLPIDEM TARTRATE SANDOZ INC Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078148
SUPPL-11 ZOLPIDEM TARTRATE ANCHEN PHARMS Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078148
SUPPL-12 ZOLPIDEM TARTRATE ANCHEN PHARMS Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078148
SUPPL-13 ZOLPIDEM TARTRATE ANCHEN PHARMS Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078148
SUPPL-15 ZOLPIDEM TARTRATE ANCHEN PHARMS Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078179
SUPPL-14 ZOLPIDEM TARTRATE ACTAVIS ELIZABETH Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078179
SUPPL-15 ZOLPIDEM TARTRATE ACTAVIS ELIZABETH Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #078179
SUPPL-16 ZOLPIDEM TARTRATE ACTAVIS ELIZABETH Labeling Approval
11/19/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
SUPPL-17 TENOFOVIR DISOPROXIL FUMARATE CIPLA Labeling Approval
11/19/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
SUPPL-18 TENOFOVIR DISOPROXIL FUMARATE CIPLA Labeling Approval
11/19/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
SUPPL-19 TENOFOVIR DISOPROXIL FUMARATE CIPLA Labeling Approval
11/19/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
SUPPL-20 TENOFOVIR DISOPROXIL FUMARATE CIPLA Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #090107
SUPPL-6 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #090107
SUPPL-7 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #090107
SUPPL-8 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #090107
SUPPL-9 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090742
SUPPL-12 TENOFOVIR DISOPROXIL FUMARATE STRIDES PHARMA Labeling Approval
11/19/2019 XYOSTED (AUTOINJECTOR)
NDA #209863
SUPPL-2 TESTOSTERONE ENANTHATE ANTARES PHARMA INC Labeling Approval
11/19/2019 TURALIO
NDA #211810
SUPPL-1 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC REMS Approval
11/19/2019 TURALIO
NDA #211810
SUPPL-2 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC REMS Approval
11/19/2019 TAVABOROLE
ANDA #212215
ORIG-1 TAVABOROLE TARO PHARMA USA INC Tentative Approval
11/19/2019 IVERMECTIN
ANDA #212485
ORIG-1 IVERMECTIN TEVA PHARMS USA Tentative Approval
11/20/2019 CAYSTON
NDA #050814
SUPPL-23 AZTREONAM GILEAD Labeling Approval
11/20/2019 MIRTAZAPINE
ANDA #076541
SUPPL-24 MIRTAZAPINE SUN PHARM INDS INC Labeling Approval
11/20/2019 LAMOTRIGINE
ANDA #077420
SUPPL-17 LAMOTRIGINE MYLAN Labeling Approval
11/20/2019 LAMOTRIGINE
ANDA #077420
SUPPL-18 LAMOTRIGINE MYLAN Labeling Approval
11/20/2019 FOSAMPRENAVIR CALCIUM
ANDA #204024
ORIG-1 FOSAMPRENAVIR CALCIUM SUN PHARM Approval
11/20/2019 HEPARIN SODIUM
ANDA #205323
SUPPL-1 HEPARIN SODIUM GLAND PHARMA LTD Labeling Approval
11/20/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481
SUPPL-1 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Labeling Approval
11/20/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481
SUPPL-2 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Labeling Approval
11/20/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481
SUPPL-3 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Labeling Approval
11/20/2019 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481
SUPPL-4 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Labeling Approval
11/20/2019 MESALAMINE
ANDA #207271
ORIG-1 MESALAMINE MYLAN Approval
11/20/2019 DEFERASIROX
ANDA #209782
ORIG-1 DEFERASIROX SUN PHARM Approval
11/20/2019 DEFERASIROX
ANDA #209878
ORIG-1 DEFERASIROX MSN Approval
11/20/2019 DEFERASIROX
ANDA #210060
ORIG-1 DEFERASIROX ALEMBIC PHARMS LTD Approval
11/20/2019 DESONIDE
ANDA #210198
ORIG-1 DESONIDE CADILA Approval
11/20/2019 DEFERASIROX
ANDA #210519
ORIG-1 DEFERASIROX ALKEM LABS LTD Approval
11/20/2019 DEFERASIROX
ANDA #210920
ORIG-1 DEFERASIROX BIONPHARMA INC Approval
11/20/2019 DEFERASIROX
ANDA #210945
ORIG-1 DEFERASIROX MSN Approval
11/20/2019 DEFERASIROX
ANDA #211383
ORIG-1 DEFERASIROX ZYDUS PHARMS Approval
11/20/2019 DEFERASIROX
ANDA #211824
ORIG-1 DEFERASIROX ALEMBIC PHARMS LTD Approval
11/20/2019 GIVLAARI
NDA #212194
ORIG-1 GIVOSIRAN SODIUM ALNYLAM PHARMS INC Type 1 - New Molecular Entity Approval
11/20/2019 MIDODRINE HYDROCHLORIDE
ANDA #212543
SUPPL-1 MIDODRINE HYDROCHLORIDE RUBICON Labeling Approval
11/20/2019 ISOSORBIDE DINITRATE
ANDA #213057
ORIG-1 ISOSORBIDE DINITRATE ZYDUS Approval
11/21/2019 CORTEF
NDA #008697
SUPPL-36 HYDROCORTISONE PHARMACIA AND UPJOHN Labeling Approval
11/21/2019 SOLU-CORTEF
NDA #009866
SUPPL-113 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
11/21/2019 FASLODEX
NDA #021344
SUPPL-38 FULVESTRANT ASTRAZENECA Efficacy Approval
11/21/2019 TREANDA
NDA #022249
SUPPL-24 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075315
SUPPL-45 AMIODARONE HYDROCHLORIDE SANDOZ Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075315
SUPPL-46 AMIODARONE HYDROCHLORIDE SANDOZ Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075315
SUPPL-47 AMIODARONE HYDROCHLORIDE SANDOZ Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075389
SUPPL-12 AMIODARONE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #078134
SUPPL-8 LAMOTRIGINE HIKMA PHARMS Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #078134
SUPPL-9 LAMOTRIGINE HIKMA PHARMS Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #078578
SUPPL-7 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #078578
SUPPL-8 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #078578
SUPPL-9 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #078578
SUPPL-10 AMIODARONE HYDROCHLORIDE RUBICON Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781
SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK GENERICS Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781
SUPPL-8 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK GENERICS Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090865
SUPPL-18 PRAMIPEXOLE DIHYDROCHLORIDE TORRENT PHARMS Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #200672
SUPPL-3 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #200672
SUPPL-6 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #200672
SUPPL-8 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #200672
SUPPL-9 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164
SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164
SUPPL-15 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/21/2019 AMPICILLIN AND SULBACTAM
ANDA #202197
SUPPL-4 AMPICILLIN SODIUM; SULBACTAM SODIUM MYLAN LABS LTD Labeling Approval
11/21/2019 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543
SUPPL-15 LEVETIRACETAM HQ SPECIALITY PHARMA Labeling Approval
11/21/2019 MYCOPHENOLIC ACID
ANDA #202720
SUPPL-2 MYCOPHENOLIC ACID TEVA PHARMS USA Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #203370
SUPPL-7 LAMOTRIGINE TORRENT Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #203370
SUPPL-9 LAMOTRIGINE TORRENT Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #203733
SUPPL-5 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #203733
SUPPL-7 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 LAMOTRIGINE
ANDA #203733
SUPPL-8 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #204742
SUPPL-2 AMIODARONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #204742
SUPPL-4 AMIODARONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #204742
SUPPL-6 AMIODARONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/21/2019 IMBRUVICA
NDA #205552
SUPPL-29 IBRUTINIB PHARMACYCLICS INC Labeling Approval
11/21/2019 OSELTAMIVIR PHOSPHATE
ANDA #208348
SUPPL-4 OSELTAMIVIR PHOSPHATE LUPIN ATLANTIS Labeling Approval
11/21/2019 OSELTAMIVIR PHOSPHATE
ANDA #208348
SUPPL-5 OSELTAMIVIR PHOSPHATE LUPIN ATLANTIS Labeling Approval
11/21/2019 IMVEXXY
NDA #208564
SUPPL-3 ESTRADIOL THERAPEUTICSMD INC Labeling Approval
11/21/2019 FULVESTRANT
ANDA #209714
ORIG-1 FULVESTRANT HBT LABS INC Approval
11/21/2019 CALQUENCE
NDA #210259
SUPPL-6 ACALABRUTINIB ASTRAZENECA Efficacy Approval
11/21/2019 CALQUENCE
NDA #210259
SUPPL-7 ACALABRUTINIB ASTRAZENECA Efficacy Approval
11/21/2019 IMBRUVICA
NDA #210563
SUPPL-4 IBRUTINIB PHARMACYCLICS INC Labeling Approval
11/21/2019 XCOPRI
NDA #212839
ORIG-1 CENOBAMATE SK LIFE Type 1 - New Molecular Entity Approval
11/21/2019 ATENOLOL
ANDA #213136
ORIG-1 ATENOLOL UNICHEM LABS LTD Approval
11/22/2019 DARANIDE
NDA #011366
SUPPL-33 DICHLORPHENAMIDE STRONGBRIDGE US Efficacy Approval
11/22/2019 KEVEYIS
NDA #011366
SUPPL-33 DICHLORPHENAMIDE STRONGBRIDGE US Efficacy Approval
11/22/2019 DEPAKENE
NDA #018081
SUPPL-70 VALPROIC ACID ABBVIE Labeling Approval
11/22/2019 DEPAKENE
NDA #018082
SUPPL-53 VALPROIC ACID ABBVIE Labeling Approval
11/22/2019 DEPAKOTE
NDA #018723
SUPPL-62 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/22/2019 DEPAKOTE
NDA #019680
SUPPL-49 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/22/2019 DEPACON
NDA #020593
SUPPL-40 VALPROATE SODIUM ABBVIE Labeling Approval
11/22/2019 TEMODAR
NDA #021029
SUPPL-33 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
11/22/2019 DEPAKOTE ER
NDA #021168
SUPPL-40 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/22/2019 TEMODAR
NDA #022277
SUPPL-13 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
11/22/2019 PRADAXA
NDA #022512
SUPPL-38 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
11/22/2019 NAMENDA XR
NDA #022525
SUPPL-15 MEMANTINE HYDROCHLORIDE FOREST LABS LLC Labeling Approval
11/22/2019 AMPICILLIN TRIHYDRATE
ANDA #062883
SUPPL-14 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC Labeling Approval
11/22/2019 NAPROXEN
ANDA #075927
SUPPL-25 NAPROXEN AMNEAL PHARMS NY Labeling Approval
11/22/2019 NAPROXEN
ANDA #075927
SUPPL-27 NAPROXEN AMNEAL PHARMS NY Labeling Approval
11/22/2019 NAPROXEN
ANDA #075927
SUPPL-31 NAPROXEN AMNEAL PHARMS NY Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076122
SUPPL-22 MIRTAZAPINE MYLAN Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076122
SUPPL-24 MIRTAZAPINE MYLAN Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076122
SUPPL-25 MIRTAZAPINE MYLAN Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-10 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-11 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-14 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-16 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-17 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-18 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-20 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 CLOPIDOGREL BISULFATE
ANDA #076274
SUPPL-23 CLOPIDOGREL BISULFATE APOTEX INC Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076921
SUPPL-29 MIRTAZAPINE AUROBINDO Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076921
SUPPL-30 MIRTAZAPINE AUROBINDO Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #076921
SUPPL-35 MIRTAZAPINE AUROBINDO Labeling Approval
11/22/2019 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077183
SUPPL-13 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #077666
SUPPL-10 MIRTAZAPINE APOTEX INC Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #077666
SUPPL-11 MIRTAZAPINE APOTEX INC Labeling Approval
11/22/2019 MIRTAZAPINE
ANDA #077666
SUPPL-13 MIRTAZAPINE APOTEX INC Labeling Approval
11/22/2019 QUETIAPINE FUMARATE
ANDA #077745
SUPPL-11 QUETIAPINE FUMARATE TEVA PHARMS Labeling Approval
11/22/2019 QUETIAPINE FUMARATE
ANDA #077745
SUPPL-12 QUETIAPINE FUMARATE TEVA PHARMS Labeling Approval
11/22/2019 PAMIDRONATE DISODIUM
ANDA #078373
SUPPL-5 PAMIDRONATE DISODIUM SAGENT PHARMS INC Labeling Approval
11/22/2019 MYCOPHENOLATE MOFETIL
ANDA #090055
SUPPL-14 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
11/22/2019 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090149
SUPPL-8 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/22/2019 MYCOPHENOLATE MOFETIL
ANDA #090456
SUPPL-16 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811
SUPPL-3 BIVALIRUDIN HOSPIRA INC Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811
SUPPL-5 BIVALIRUDIN HOSPIRA INC Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811
SUPPL-8 BIVALIRUDIN HOSPIRA INC Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811
SUPPL-10 BIVALIRUDIN HOSPIRA INC Labeling Approval
11/22/2019 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
ANDA #091211
SUPPL-9 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLENMARK GENERICS Labeling Approval
11/22/2019 NAPROXEN SODIUM
ANDA #091353
SUPPL-8 NAPROXEN SODIUM GRANULES INDIA Labeling Approval
11/22/2019 NAPROXEN SODIUM
ANDA #091353
SUPPL-10 NAPROXEN SODIUM GRANULES INDIA Labeling Approval
11/22/2019 NAPROXEN SODIUM
ANDA #091353
SUPPL-13 NAPROXEN SODIUM GRANULES INDIA Labeling Approval
11/22/2019 QUETIAPINE FUMARATE
ANDA #202152
SUPPL-15 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
11/22/2019 QUETIAPINE FUMARATE
ANDA #202152
SUPPL-16 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
11/22/2019 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
ANDA #202362
SUPPL-3 ATOVAQUONE; PROGUANIL HYDROCHLORIDE MYLAN Labeling Approval
11/22/2019 LAMOTRIGINE
ANDA #202887
SUPPL-8 LAMOTRIGINE RUBICON Labeling Approval
11/22/2019 LAMOTRIGINE
ANDA #202887
SUPPL-11 LAMOTRIGINE RUBICON Labeling Approval
11/22/2019 CABAZITAXEL
NDA #207937
ORIG-1 CABAZITAXEL FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Tentative Approval
11/22/2019 CABAZITAXEL
NDA #207937
SUPPL-1 CABAZITAXEL FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Tentative Approval
11/22/2019 SILODOSIN
ANDA #211731
ORIG-1 SILODOSIN ALEMBIC PHARMS LTD Approval
11/22/2019 EXSERVAN
NDA #212640
ORIG-1 RILUZOLE AQUESTIVE THERAP Type 3 - New Dosage Form Approval
11/22/2019 AMPHETAMINE SULFATE
ANDA #212919
ORIG-1 AMPHETAMINE SULFATE BIONPHARMA INC Approval
11/22/2019 BUTALBITAL AND ACETAMINOPHEN
ANDA #213115
ORIG-1 ACETAMINOPHEN; BUTALBITAL GRANULES PHARMS Approval
11/22/2019 TREMFYA
BLA #761061
SUPPL-4 GUSELKUMAB JANSSEN BIOTECH Approval
11/25/2019 NIZORAL A-D
NDA #020310
SUPPL-23 KETOCONAZOLE KRAMER Labeling Approval
11/25/2019 NAPROXEN SODIUM
ANDA #075416
SUPPL-19 NAPROXEN SODIUM ACTAVIS LABS FL INC Labeling Approval
11/25/2019 FLUTICASONE PROPIONATE
ANDA #076300
SUPPL-5 FLUTICASONE PROPIONATE FOUGERA PHARMS Labeling Approval
11/25/2019 FLUTICASONE PROPIONATE
ANDA #076504
SUPPL-11 FLUTICASONE PROPIONATE HIKMA Labeling Approval
11/25/2019 FLUTICASONE PROPIONATE
ANDA #077145
SUPPL-1 FLUTICASONE PROPIONATE TARO PHARM INDS Labeling Approval
11/25/2019 FLUTICASONE PROPIONATE
ANDA #077168
SUPPL-7 FLUTICASONE PROPIONATE COSETTE Labeling Approval
11/25/2019 LEVETIRACETAM
ANDA #091399
SUPPL-14 LEVETIRACETAM LUPIN LTD Labeling Approval
11/25/2019 LEVETIRACETAM
ANDA #091399
SUPPL-16 LEVETIRACETAM LUPIN LTD Labeling Approval
11/25/2019 LEVETIRACETAM
ANDA #091399
SUPPL-17 LEVETIRACETAM LUPIN LTD Labeling Approval
11/25/2019 LEVETIRACETAM
ANDA #091399
SUPPL-18 LEVETIRACETAM LUPIN LTD Labeling Approval
11/25/2019 LEVETIRACETAM
ANDA #091399
SUPPL-21 LEVETIRACETAM LUPIN LTD Manufacturing (CMC) Approval
11/25/2019 NAPROXEN
ANDA #091432
SUPPL-3 NAPROXEN SUNRISE PHARM INC Labeling Approval
11/25/2019 NAPROXEN
ANDA #091432
SUPPL-6 NAPROXEN SUNRISE PHARM INC Labeling Approval
11/25/2019 NAPROXEN
ANDA #091432
SUPPL-9 NAPROXEN SUNRISE PHARM INC Labeling Approval
11/25/2019 RITUXAN
BLA #103705
SUPPL-5459 RITUXIMAB GENENTECH Approval
11/25/2019 ZALTRAP
BLA #125418
SUPPL-45 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
11/25/2019 MYCOPHENOLATE MOFETIL
ANDA #203005
SUPPL-8 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
11/25/2019 XADAGO
NDA #207145
SUPPL-5 SAFINAMIDE MESYLATE MDD US Labeling Approval
11/25/2019 DEFERASIROX
ANDA #209223
ORIG-1 DEFERASIROX TEVA PHARMS USA Approval
11/25/2019 MYCOPHENOLATE MOFETIL
ANDA #210181
SUPPL-1 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD Labeling Approval
11/25/2019 MYCOPHENOLATE MOFETIL
ANDA #210370
SUPPL-2 MYCOPHENOLATE MOFETIL VISTAPHARM Labeling Approval
11/25/2019 PILOCARPINE HYDROCHLORIDE
ANDA #210384
ORIG-1 PILOCARPINE HYDROCHLORIDE SOMERSET THERAPS LLC Approval
11/25/2019 CLADRIBINE
ANDA #210856
ORIG-1 CLADRIBINE HISUN PHARM HANGZHOU Approval
11/25/2019 ADAPALENE AND BENZOYL PEROXIDE
ANDA #212464
ORIG-1 ADAPALENE; BENZOYL PEROXIDE PERRIGO UK FINCO LTD PARTNERSHIP Tentative Approval
11/25/2019 METFORMIN HYDROCHLORIDE
ANDA #212969
ORIG-1 METFORMIN HYDROCHLORIDE GLENMARK PHARMS LTD Approval
11/25/2019 OXBRYTA
NDA #213137
ORIG-1 VOXELOTOR GLOBAL BLOOD THERAPS Type 1 - New Molecular Entity Approval
11/26/2019 MAGNESIUM SULFATE
ANDA #075151
SUPPL-15 MAGNESIUM SULFATE HOSPIRA Labeling Approval
11/26/2019 NAPROXEN
ANDA #076494
SUPPL-15 NAPROXEN HIKMA INTL PHARMS Labeling Approval
11/26/2019 NAPROXEN
ANDA #076494
SUPPL-16 NAPROXEN HIKMA INTL PHARMS Labeling Approval
11/26/2019 NAPROXEN
ANDA #076494
SUPPL-17 NAPROXEN HIKMA INTL PHARMS Labeling Approval
11/26/2019 GEMFIBROZIL
ANDA #077836
SUPPL-14 GEMFIBROZIL INVAGEN PHARMS Labeling Approval
11/26/2019 RISPERIDONE
ANDA #078516
SUPPL-13 RISPERIDONE ZYDUS PHARMS USA Labeling Approval
11/26/2019 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
ANDA #078959
SUPPL-6 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE SEPTODONT INC Labeling Approval
11/26/2019 CAMPATH
BLA #103948
SUPPL-5171 ALEMTUZUMAB GENZYME Approval
11/26/2019 LEMTRADA
BLA #103948
SUPPL-5171 ALEMTUZUMAB GENZYME Approval
11/26/2019 ELIQUIS
NDA #202155
SUPPL-24 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
11/26/2019 SYNRIBO
NDA #203585
SUPPL-7 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Labeling Approval
11/26/2019 TOUJEO MAX SOLOSTAR
BLA #206538
SUPPL-12 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/26/2019 TOUJEO SOLOSTAR
BLA #206538
SUPPL-12 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
11/26/2019 RIVASTIGMINE
ANDA #209063
ORIG-1 RIVASTIGMINE BRECKENRIDGE Approval
11/26/2019 AMINOCAPROIC ACID
ANDA #212492
ORIG-1 AMINOCAPROIC ACID AMNEAL Approval
11/26/2019 POTASSIUM PHOSPHATES
NDA #212832
ORIG-1 POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
11/26/2019 FLUOCINONIDE
ANDA #212976
ORIG-1 FLUOCINONIDE XIROMED Approval
11/27/2019 LIPITOR
NDA #020702
SUPPL-74 ATORVASTATIN CALCIUM UPJOHN Labeling Approval
11/27/2019 TRIAMCINOLONE ACETONIDE
ANDA #040039
SUPPL-17 TRIAMCINOLONE ACETONIDE TARO PHARM INDS LTD Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL
ANDA #065410
SUPPL-12 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL
ANDA #065413
SUPPL-13 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-11 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-12 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-13 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-14 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-15 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-16 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 DIVALPROEX SODIUM
ANDA #077615
SUPPL-17 DIVALPROEX SODIUM APOTEX Labeling Approval
11/27/2019 FLUTICASONE PROPIONATE
ANDA #091553
SUPPL-4 FLUTICASONE PROPIONATE PERRIGO ISRAEL Labeling Approval
11/27/2019 FLUTICASONE PROPIONATE
ANDA #091553
SUPPL-9 FLUTICASONE PROPIONATE PERRIGO ISRAEL Labeling Approval
11/27/2019 COMPLERA
NDA #202123
SUPPL-31 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
11/27/2019 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202525
SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE WATSON LABS INC Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043
SUPPL-1 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AKORN INC Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043
SUPPL-3 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AKORN INC Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043
SUPPL-4 MYCOPHENOLATE MOFETIL HYDROCHLORIDE AKORN INC Labeling Approval
11/27/2019 MACRILEN
NDA #205598
SUPPL-3 MACIMORELIN ACETATE NOVO Labeling Approval
11/27/2019 MAGNESIUM SULFATE
ANDA #206039
SUPPL-3 MAGNESIUM SULFATE EXELA PHARMA Labeling Approval
11/27/2019 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #207349
SUPPL-5 MAGNESIUM SULFATE HQ SPCLT PHARMA Labeling Approval
11/27/2019 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #207349
SUPPL-7 MAGNESIUM SULFATE HQ SPCLT PHARMA Labeling Approval
11/27/2019 FLUTICASONE PROPIONATE
ANDA #207957
SUPPL-4 FLUTICASONE PROPIONATE HIKMA Labeling Approval
11/27/2019 OZEMPIC
NDA #209637
SUPPL-4 SEMAGLUTIDE NOVO Labeling Approval
11/27/2019 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #209932
SUPPL-1 MAGNESIUM SULFATE MYLAN LABS LTD Labeling Approval
11/27/2019 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #209932
SUPPL-2 MAGNESIUM SULFATE MYLAN LABS LTD Labeling Approval
11/27/2019 ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #210212
ORIG-1 ALOGLIPTIN AND METFORMIN HYDROCHLORIDE MSN LABORATORIES PRIVATE LTD Tentative Approval
11/27/2019 CELECOXIB
ANDA #210628
ORIG-1 CELECOXIB UMEDICA LABS PVT LTD Approval
11/27/2019 REDITREX
NDA #210737
ORIG-1 METHOTREXATE CUMBERLAND PHARMS Type 5 - New Formulation or New Manufacturer Approval
11/27/2019 REDITREX
NDA #210737
ORIG-2 METHOTREXATE CUMBERLAND PHARMS Efficacy Approval
11/27/2019 SILDENAFIL CITRATE
ANDA #211092
ORIG-1 SILDENAFIL CITRATE AMNEAL PHARMS Approval
11/27/2019 QUZYTTIR
NDA #211415
SUPPL-1 CETIRIZINE HYDROCHLORIDE JDP Labeling Approval
11/27/2019 CHLORZOXAZONE
ANDA #212253
ORIG-1 CHLORZOXAZONE NOVITIUM PHARMA Approval
11/27/2019 SILDENAFIL CITRATE
ANDA #212440
ORIG-1 SILDENAFIL CITRATE ALKEM LABS LTD Approval
11/27/2019 SILDENAFIL CITRATE
ANDA #212883
ORIG-1 SILDENAFIL CITRATE AJANTA PHARMA LTD Approval
11/27/2019 NEBIVOLOL
ANDA #212917
ORIG-1 NEBIVOLOL REYOUNG PHARMA Tentative Approval
11/28/2019 BANZEL
NDA #021911
SUPPL-17 RUFINAMIDE EISAI INC Labeling Approval
11/28/2019 BANZEL
NDA #201367
SUPPL-8 RUFINAMIDE EISAI INC Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #077562
SUPPL-12 ZIPRASIDONE HYDROCHLORIDE SANDOZ INC Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #077562
SUPPL-14 ZIPRASIDONE HYDROCHLORIDE SANDOZ INC Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565
SUPPL-11 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565
SUPPL-12 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-23 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-24 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-25 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-27 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-28 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #077903
SUPPL-29 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908
SUPPL-8 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908
SUPPL-13 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-5 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-6 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-7 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-9 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-10 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-11 ZOLPIDEM TARTRATE LUPIN LTD Manufacturing (CMC) Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #078970
SUPPL-12 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992
SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE INTELLIPHARMACEUTICS Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992
SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE INTELLIPHARMACEUTICS Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108
SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108
SUPPL-6 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
11/29/2019 PREGABALIN
ANDA #091157
ORIG-1 PREGABALIN SUN PHARM Approval
11/29/2019 ANTHIM
BLA #125509
SUPPL-15 OBILTOXAXIMAB ELUSYS THERAPEUTICS INC Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #201231
SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #201231
SUPPL-9 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
11/29/2019 TEMOZOLOMIDE
ANDA #201528
SUPPL-3 TEMOZOLOMIDE ACCORD HLTHCARE Labeling Approval
11/29/2019 TEMOZOLOMIDE
ANDA #201742
SUPPL-11 TEMOZOLOMIDE SUN PHARM Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202580
SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE MYLAN Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202580
SUPPL-5 DEXMETHYLPHENIDATE HYDROCHLORIDE MYLAN Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202731
SUPPL-5 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202731
SUPPL-10 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202842
SUPPL-1 DEXMETHYLPHENIDATE HYDROCHLORIDE PAR PHARM INC Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202842
SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE PAR PHARM INC Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #203146
SUPPL-17 RIZATRIPTAN BENZOATE MACLEODS PHARMS LTD Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #203147
SUPPL-15 RIZATRIPTAN BENZOATE MACLEODS PHARMS LTD Labeling Approval
11/29/2019 TEMOZOLOMIDE
ANDA #203490
SUPPL-3 TEMOZOLOMIDE AMERIGEN PHARMS LTD Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #203614
SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
11/29/2019 DESVENLAFAXINE SUCCINATE
ANDA #204065
SUPPL-2 DESVENLAFAXINE SUCCINATE ACTAVIS LABS FL Labeling Approval
11/29/2019 DESVENLAFAXINE SUCCINATE
ANDA #204065
SUPPL-5 DESVENLAFAXINE SUCCINATE ACTAVIS LABS FL Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #204090
SUPPL-1 RIZATRIPTAN BENZOATE EMCURE PHARMS LTD Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #204090
SUPPL-2 RIZATRIPTAN BENZOATE EMCURE PHARMS LTD Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #204117
SUPPL-1 ZIPRASIDONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #204117
SUPPL-3 ZIPRASIDONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/29/2019 RABEPRAZOLE SODIUM
ANDA #204237
SUPPL-2 RABEPRAZOLE SODIUM RUBICON Labeling Approval
11/29/2019 RABEPRAZOLE SODIUM
ANDA #204237
SUPPL-6 RABEPRAZOLE SODIUM RUBICON Labeling Approval
11/29/2019 RABEPRAZOLE SODIUM
ANDA #204237
SUPPL-8 RABEPRAZOLE SODIUM RUBICON Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266
SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE MYLAN Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266
SUPPL-5 DEXMETHYLPHENIDATE HYDROCHLORIDE MYLAN Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #204299
SUPPL-1 ZOLPIDEM TARTRATE NOVEL LABS INC Labeling Approval
11/29/2019 ZOLPIDEM TARTRATE
ANDA #204299
SUPPL-7 ZOLPIDEM TARTRATE NOVEL LABS INC Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #204339
SUPPL-3 RIZATRIPTAN BENZOATE INVAGEN PHARMS Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #204339
SUPPL-9 RIZATRIPTAN BENZOATE INVAGEN PHARMS Labeling Approval
11/29/2019 TEMOZOLOMIDE
ANDA #206413
SUPPL-1 TEMOZOLOMIDE CHARTWELL Labeling Approval
11/29/2019 TEMOZOLOMIDE
ANDA #206750
SUPPL-1 TEMOZOLOMIDE ZYDUS PHARMS Labeling Approval
11/29/2019 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #206834
ORIG-1 ENOXAPARIN SODIUM NANJING KING-FRIEND Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #207836
SUPPL-1 RIZATRIPTAN BENZOATE UNICHEM LABS LTD Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #207901
SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE TRIS PHARMA INC Labeling Approval
11/29/2019 AMBRISENTAN
ANDA #208252
SUPPL-1 AMBRISENTAN WATSON LABS INC Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209468
SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
11/29/2019 AMBRISENTAN
ANDA #209509
SUPPL-1 AMBRISENTAN PAR PHARM INC Labeling Approval
11/29/2019 TERIFLUNOMIDE
ANDA #209613
SUPPL-1 TERIFLUNOMIDE AMNEAL PHARMS CO Labeling Approval
11/29/2019 TERIFLUNOMIDE
ANDA #209638
SUPPL-1 TERIFLUNOMIDE AUROBINDO PHARMA LTD Labeling Approval
11/29/2019 TERIFLUNOMIDE
ANDA #209638
SUPPL-2 TERIFLUNOMIDE AUROBINDO PHARMA LTD Labeling Approval
11/29/2019 TERIFLUNOMIDE
ANDA #209663
SUPPL-1 TERIFLUNOMIDE GLENMARK PHARMS Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #210279
SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE ADARE PHARMS INC Labeling Approval
11/29/2019 SODIUM NITROPRUSSIDE
ANDA #211016
ORIG-1 SODIUM NITROPRUSSIDE CAPLIN Approval
11/29/2019 TRIAMCINOLONE ACETONIDE
ANDA #212384
ORIG-1 TRIAMCINOLONE ACETONIDE ENCUBE Approval
11/29/2019 DICLOFENAC SODIUM
ANDA #212506
ORIG-1 DICLOFENAC SODIUM ALEOR DERMACEUTICALS Tentative Approval

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