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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 May 10, 2024.

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 LINEZOLID
ANDA #210702		 SUPPL-1 LINEZOLID CHARTWELL RX 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 MEITHEAL Labeling Approval
11/04/2019 OCTREOTIDE ACETATE
ANDA #075959		 SUPPL-29 OCTREOTIDE ACETATE MEITHEAL 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 CHARTWELL MOLECULAR Labeling Approval
11/04/2019 ZALEPLON
ANDA #077505		 SUPPL-2 ZALEPLON CHARTWELL MOLECULAR Labeling Approval
11/04/2019 ZALEPLON
ANDA #077505		 SUPPL-3 ZALEPLON CHARTWELL MOLECULAR 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 Labeling Approval
11/04/2019 METRONIDAZOLE
ANDA #079065		 SUPPL-10 METRONIDAZOLE ALEMBIC 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 CHARTWELL RX Labeling Approval
11/04/2019 PRASUGREL
ANDA #205790		 SUPPL-2 PRASUGREL HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/04/2019 PRASUGREL
ANDA #205888		 SUPPL-1 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/04/2019 PRASUGREL
ANDA #205888		 SUPPL-2 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA 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 TELMISARTAN
ANDA #207016		 SUPPL-4 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 Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #208451		 SUPPL-3 ESZOPICLONE AUROBINDO PHARMA Labeling Approval
11/04/2019 ESZOPICLONE
ANDA #208451		 SUPPL-5 ESZOPICLONE AUROBINDO PHARMA 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 EUGIA PHARMA 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 BAUSCH 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 EUGIA PHARMA 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 RISING 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
NDA #209359		 ORIG-1 EPINEPHRINE HOSPIRA 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 New Combination and New Formulation or New Manufacturer Approval
11/05/2019 ERLOTINIB HYDROCHLORIDE
ANDA #211960		 ORIG-1 ERLOTINIB HYDROCHLORIDE SHILPA 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 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076374		 SUPPL-10 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE CHARTWELL RX 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 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 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 ORGANON 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 PHARMS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926		 SUPPL-6 MONTELUKAST SODIUM GLENMARK PHARMS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926		 SUPPL-8 MONTELUKAST SODIUM GLENMARK PHARMS LTD Labeling Approval
11/07/2019 MONTELUKAST SODIUM
ANDA #090926		 SUPPL-11 MONTELUKAST SODIUM GLENMARK PHARMS LTD 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 KEY THERAP 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 CHARTWELL RX Labeling Approval
11/07/2019 ATOVAQUONE
ANDA #207833		 SUPPL-2 ATOVAQUONE CHARTWELL RX Labeling 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 IBUPROFEN
ANDA #078682		 SUPPL-20 IBUPROFEN BIONPHARMA Manufacturing (CMC) 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 PHARMS LTD Labeling Approval
11/12/2019 ESZOPICLONE
ANDA #091166		 SUPPL-5 ESZOPICLONE GLENMARK PHARMS LTD Labeling Approval
11/12/2019 ESZOPICLONE
ANDA #091166		 SUPPL-6 ESZOPICLONE GLENMARK PHARMS LTD 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 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 AVONDALE PHARMS Labeling Approval
11/14/2019 DIFLORASONE DIACETATE
ANDA #075374		 SUPPL-12 DIFLORASONE DIACETATE AVONDALE 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 HIKMA 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 PADAGIS ISRAEL Labeling Approval
11/14/2019 CLOBETASOL PROPIONATE
ANDA #077763		 SUPPL-13 CLOBETASOL PROPIONATE PADAGIS ISRAEL Labeling Approval
11/14/2019 TEMOZOLOMIDE
ANDA #078879		 SUPPL-15 TEMOZOLOMIDE HERITAGE 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 PHARMS LTD Labeling Approval
11/14/2019 FLUTICASONE PROPIONATE
ANDA #090759		 SUPPL-5 FLUTICASONE PROPIONATE GLENMARK PHARMS LTD 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 DR REDDYS LABS SA Labeling Approval
11/14/2019 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189		 SUPPL-5 METHAMPHETAMINE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
11/14/2019 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189		 SUPPL-6 METHAMPHETAMINE HYDROCHLORIDE DR REDDYS LABS SA 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 RISING 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 ANI PHARMS 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 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 HALEON US HOLDINGS Labeling Approval
11/15/2019 NICORETTE (MINT)
NDA #020066		 SUPPL-64 NICOTINE POLACRILEX HALEON US HOLDINGS 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 Labeling Approval
11/15/2019 MIRTAZAPINE
ANDA #077376		 SUPPL-17 MIRTAZAPINE AUROBINDO PHARMA Labeling Approval
11/15/2019 MIRTAZAPINE
ANDA #077376		 SUPPL-22 MIRTAZAPINE AUROBINDO PHARMA Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC Labeling Approval
11/15/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078894		 SUPPL-7 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC 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 Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-3 ZOLPIDEM TARTRATE APOTEX Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-4 ZOLPIDEM TARTRATE APOTEX Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-5 ZOLPIDEM TARTRATE APOTEX Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-6 ZOLPIDEM TARTRATE APOTEX Labeling Approval
11/15/2019 ZOLPIDEM TARTRATE
ANDA #200266		 SUPPL-7 ZOLPIDEM TARTRATE APOTEX 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 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 Labeling Approval
11/16/2019 CEFUROXIME
ANDA #065048		 SUPPL-17 CEFUROXIME HIKMA Labeling Approval
11/16/2019 CEFUROXIME SODIUM
ANDA #065048		 SUPPL-17 CEFUROXIME SODIUM HIKMA Labeling Approval
11/16/2019 AMPICILLIN AND SULBACTAM
ANDA #065176		 SUPPL-14 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA Labeling Approval
11/16/2019 AMPICILLIN AND SULBACTAM
ANDA #065188		 SUPPL-16 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA 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 Labeling Approval
11/18/2019 ECOZA
NDA #205175		 SUPPL-3 ECONAZOLE NITRATE RESILIA PHARMS 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 CHARTWELL RX 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 SANDOZ 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 SANDOZ Labeling Approval
11/19/2019 RITALIN LA
NDA #021284		 SUPPL-41 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
11/19/2019 FOCALIN XR
NDA #021802		 SUPPL-36 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-15 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-16 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-17 ZOLPIDEM TARTRATE SANDOZ Labeling Approval
11/19/2019 ZOLPIDEM TARTRATE
ANDA #077322		 SUPPL-18 ZOLPIDEM TARTRATE SANDOZ 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
11/20/2019 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 RISING Labeling Approval
11/20/2019 LAMOTRIGINE
ANDA #077420		 SUPPL-18 LAMOTRIGINE RISING 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 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 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 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 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 UPSHER SMITH LABS Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-46 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-47 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
11/21/2019 AMIODARONE HYDROCHLORIDE
ANDA #075389		 SUPPL-12 AMIODARONE HYDROCHLORIDE DR REDDYS LABS SA 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 PHARMS LTD Labeling Approval
11/21/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-8 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK PHARMS LTD 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 STERISCIENCE Labeling Approval
11/21/2019 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-15 LEVETIRACETAM HQ SPCLT PHARMA Labeling Approval
11/21/2019 MYCOPHENOLIC SODIUM
ANDA #202720		 SUPPL-2 MYCOPHENOLIC SODIUM 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 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 LLC Labeling Approval
11/21/2019 OSELTAMIVIR PHOSPHATE
ANDA #208348		 SUPPL-4 OSELTAMIVIR PHOSPHATE LUPIN Labeling Approval
11/21/2019 OSELTAMIVIR PHOSPHATE
ANDA #208348		 SUPPL-5 OSELTAMIVIR PHOSPHATE LUPIN Labeling Approval
11/21/2019 IMVEXXY
NDA #208564		 SUPPL-3 ESTRADIOL MAYNE PHARMA 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 LLC 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 Approval
11/22/2019 DARANIDE
NDA #011366		 SUPPL-33 DICHLORPHENAMIDE XERIS Efficacy Approval
11/22/2019 KEVEYIS
NDA #011366		 SUPPL-33 DICHLORPHENAMIDE XERIS 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 RISPERDAL CONSTA
NDA #021346		 SUPPL-62 RISPERIDONE JANSSEN PHARMS 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 ABBVIE Labeling Approval
11/22/2019 AMPICILLIN TRIHYDRATE
ANDA #062883		 SUPPL-14 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA 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 Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811		 SUPPL-5 BIVALIRUDIN HOSPIRA Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811		 SUPPL-8 BIVALIRUDIN HOSPIRA Labeling Approval
11/22/2019 BIVALIRUDIN
ANDA #090811		 SUPPL-10 BIVALIRUDIN HOSPIRA Labeling Approval
11/22/2019 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
ANDA #091211		 SUPPL-9 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLENMARK PHARMS LTD 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 Approval
11/22/2019 EXSERVAN
NDA #212640		 ORIG-1 RILUZOLE AQUESTIVE Type 3 - New Dosage Form Approval
11/22/2019 AMPHETAMINE SULFATE
ANDA #212919		 ORIG-1 AMPHETAMINE SULFATE BIONPHARMA Approval
11/22/2019 BUTALBITAL AND ACETAMINOPHEN
ANDA #213115		 ORIG-1 ACETAMINOPHEN; BUTALBITAL GRANULES Approval
11/22/2019 TREMFYA
BLA #761061		 SUPPL-4 GUSELKUMAB JANSSEN BIOTECH Approval
11/25/2019 NIZORAL ANTI-DANDRUFF
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 NUVO PHARMS INC Labeling Approval
11/25/2019 NAPROXEN
ANDA #091432		 SUPPL-6 NAPROXEN NUVO PHARMS INC Labeling Approval
11/25/2019 NAPROXEN
ANDA #091432		 SUPPL-9 NAPROXEN NUVO PHARMS 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 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 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 PADAGIS ISRAEL Labeling Approval
11/27/2019 FLUTICASONE PROPIONATE
ANDA #091553		 SUPPL-9 FLUTICASONE PROPIONATE PADAGIS 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 INDOCO Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043		 SUPPL-1 MYCOPHENOLATE MOFETIL HYDROCHLORIDE RISING Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043		 SUPPL-3 MYCOPHENOLATE MOFETIL HYDROCHLORIDE RISING Labeling Approval
11/27/2019 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204043		 SUPPL-4 MYCOPHENOLATE MOFETIL HYDROCHLORIDE RISING 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 Approval
11/27/2019 REDITREX
NDA #210737		 ORIG-1 METHOTREXATE NORDIC GRP Type 5 - New Formulation or New Manufacturer Approval
11/27/2019 REDITREX
NDA #210737		 ORIG-2 METHOTREXATE NORDIC GRP 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
11/28/2019 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 AUROLIFE PHARMA LLC Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202580		 SUPPL-5 DEXMETHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC 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 ANI PHARMS 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 AVET LIFESCIENCES Labeling Approval
11/29/2019 RIZATRIPTAN BENZOATE
ANDA #204090		 SUPPL-2 RIZATRIPTAN BENZOATE AVET LIFESCIENCES Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #204117		 SUPPL-1 ZIPRASIDONE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/29/2019 ZIPRASIDONE HYDROCHLORIDE
ANDA #204117		 SUPPL-3 ZIPRASIDONE HYDROCHLORIDE AUROBINDO PHARMA 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 AUROLIFE PHARMA LLC Labeling Approval
11/29/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266		 SUPPL-5 DEXMETHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC 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 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 Labeling Approval
11/29/2019 TERIFLUNOMIDE
ANDA #209638		 SUPPL-2 TERIFLUNOMIDE AUROBINDO PHARMA 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
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