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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 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 April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/2019 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-42 HEPARIN SODIUM HOSPIRA Labeling Approval
08/01/2019 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 SUPPL-42 HEPARIN SODIUM HOSPIRA Labeling Approval
08/01/2019 MIGRANAL
NDA #020148		 SUPPL-25 DIHYDROERGOTAMINE MESYLATE BAUSCH Labeling Approval
08/01/2019 ULTRAVIST 150
NDA #020220		 SUPPL-47 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ULTRAVIST 240
NDA #020220		 SUPPL-47 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ULTRAVIST 300
NDA #020220		 SUPPL-47 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220		 SUPPL-47 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ULTRAVIST 370
NDA #020220		 SUPPL-47 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ULTRAVIST (PHARMACY BULK)
NDA #021425		 SUPPL-30 IOPROMIDE BAYER HLTHCARE Labeling Approval
08/01/2019 ZARXIO
BLA #125553		 SUPPL-17 FILGRASTIM-SNDZ SANDOZ INC Approval
08/01/2019 CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
NDA #208083		 SUPPL-3 CLINDAMYCIN PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
08/01/2019 TOLCAPONE
ANDA #210095		 ORIG-1 TOLCAPONE DR REDDYS LABS SA Approval
08/01/2019 PINDOLOL
ANDA #211712		 ORIG-1 PINDOLOL BAYSHORE PHARMS LLC Approval
08/01/2019 METHENAMINE HIPPURATE
ANDA #212172		 ORIG-1 METHENAMINE HIPPURATE MICRO LABS Approval
08/02/2019 TAMIFLU
NDA #021087		 SUPPL-71 OSELTAMIVIR PHOSPHATE ROCHE Efficacy Approval
08/02/2019 TAMIFLU
NDA #021246		 SUPPL-54 OSELTAMIVIR PHOSPHATE ROCHE Efficacy Approval
08/02/2019 ARRANON
NDA #021877		 SUPPL-12 NELARABINE SANDOZ Manufacturing (CMC) Approval
08/02/2019 IDAMYCIN
NDA #050661		 SUPPL-15 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/02/2019 IDAMYCIN PFS
NDA #050734		 SUPPL-25 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-20 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-21 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-23 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-24 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-25 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-9 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-11 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-12 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-15 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-16 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
08/02/2019 CASPOFUNGIN ACETATE
ANDA #200833		 SUPPL-3 CASPOFUNGIN ACETATE HENGRUI PHARMA Labeling Approval
08/02/2019 ITRACONAZOLE
ANDA #208481		 ORIG-1 ITRACONAZOLE APOTEX Approval
08/02/2019 OLOPATADINE HYDROCHLORIDE
ANDA #209619		 ORIG-1 OLOPATADINE HYDROCHLORIDE GLAND PHARMA LTD Approval
08/02/2019 BIKTARVY
NDA #210251		 SUPPL-6 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
08/02/2019 SUCCINYLCHOLINE CHLORIDE
ANDA #210698		 ORIG-1 SUCCINYLCHOLINE CHLORIDE DR REDDYS Approval
08/02/2019 TURALIO
NDA #211810		 ORIG-1 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC Type 1 - New Molecular Entity Approval
08/05/2019 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-106 MANNITOL BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016673		 SUPPL-149 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #016694		 SUPPL-121 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-75 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Labeling Approval
08/05/2019 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-75 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-21 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-21 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-21 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020179		 SUPPL-12 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020179		 SUPPL-56 DEXTROSE BAXTER HLTHCARE Labeling Approval
08/05/2019 COARTEM
NDA #022268		 SUPPL-21 ARTEMETHER; LUMEFANTRINE NOVARTIS Labeling Approval
08/05/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-8 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
08/05/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-9 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
08/05/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-10 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
08/05/2019 SPIRONOLACTONE
ANDA #091426		 SUPPL-9 SPIRONOLACTONE AMNEAL PHARMS Labeling Approval
08/05/2019 TYSABRI
BLA #125104		 SUPPL-966 NATALIZUMAB BIOGEN IDEC Approval
08/05/2019 SPIRONOLACTONE
ANDA #203512		 SUPPL-2 SPIRONOLACTONE ACCORD HLTHCARE Labeling Approval
08/05/2019 ZILEUTON
ANDA #204929		 SUPPL-2 ZILEUTON RISING Labeling Approval
08/05/2019 VALPROIC ACID
ANDA #207611		 ORIG-1 VALPROIC ACID EYWA Approval
08/05/2019 VINORELBINE TARTRATE
ANDA #208997		 ORIG-1 VINORELBINE TARTRATE NOVAST LABS Approval
08/05/2019 AMPHETAMINE SULFATE
ANDA #212619		 ORIG-1 AMPHETAMINE SULFATE GRANULES Approval
08/06/2019 CHLORTHALIDONE
ANDA #211627		 ORIG-1 CHLORTHALIDONE UNICHEM Approval
08/07/2019 IMODIUM A-D
NDA #019487		 SUPPL-34 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
08/07/2019 ZYRTEC ALLERGY
NDA #019835		 SUPPL-40 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
08/07/2019 ZYRTEC HIVES RELIEF
NDA #019835		 SUPPL-40 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
08/07/2019 ALEVE
NDA #020204		 SUPPL-68 NAPROXEN SODIUM BAYER Labeling Approval
08/07/2019 ABILIFY
NDA #021436		 SUPPL-43 ARIPIPRAZOLE OTSUKA Labeling Approval
08/07/2019 RANEXA
NDA #021526		 SUPPL-34 RANOLAZINE MENARINI INTL Labeling Approval
08/07/2019 ABILIFY
NDA #021713		 SUPPL-34 ARIPIPRAZOLE OTSUKA Labeling Approval
08/07/2019 ABILIFY
NDA #021729		 SUPPL-26 ARIPIPRAZOLE OTSUKA Labeling Approval
08/07/2019 NOVOLOG MIX 50/50
BLA #021810		 SUPPL-17 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
08/07/2019 ABILIFY
NDA #021866		 SUPPL-28 ARIPIPRAZOLE OTSUKA Labeling Approval
08/07/2019 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-15 ENALAPRIL MALEATE TARO Labeling Approval
08/07/2019 ENALAPRIL MALEATE
ANDA #075657		 SUPPL-17 ENALAPRIL MALEATE TARO Labeling Approval
08/07/2019 SIMVASTATIN
ANDA #077691		 SUPPL-38 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
08/07/2019 SIMVASTATIN
ANDA #077837		 SUPPL-38 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
08/07/2019 SIMVASTATIN
ANDA #077837		 SUPPL-39 SIMVASTATIN ZYDUS PHARMS USA Labeling Approval
08/07/2019 BISOPROLOL FUMARATE
ANDA #078635		 SUPPL-17 BISOPROLOL FUMARATE UNICHEM Labeling Approval
08/07/2019 BENAZEPRIL HYDROCHLORIDE
ANDA #078848		 SUPPL-5 BENAZEPRIL HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
08/07/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-5 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Labeling Approval
08/07/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-8 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-8 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-9 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-10 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-11 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-13 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-14 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
08/07/2019 REOPRO
BLA #103575		 SUPPL-5138 ABCIXIMAB CENTOCOR INC Approval
08/07/2019 REOPRO
BLA #103575		 SUPPL-5318 ABCIXIMAB CENTOCOR INC Approval
08/07/2019 TELMISARTAN
ANDA #203171		 SUPPL-6 TELMISARTAN TORRENT Labeling Approval
08/07/2019 OMEGA-3-ACID ETHYL ESTERS
ANDA #206455		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS CHARTWELL Approval
08/07/2019 CELECOXIB
ANDA #208856		 ORIG-1 CELECOXIB QINGDAO BAHEAL PHARM Approval
08/07/2019 DOXERCALCIFEROL
ANDA #208974		 SUPPL-3 DOXERCALCIFEROL AMNEAL Labeling Approval
08/07/2019 DOXERCALCIFEROL
ANDA #208975		 SUPPL-3 DOXERCALCIFEROL AMNEAL Labeling Approval
08/07/2019 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-2 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
08/07/2019 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-6 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
08/07/2019 BIMATOPROST
ANDA #210144		 ORIG-1 BIMATOPROST ALEMBIC PHARMS LTD Tentative Approval
08/07/2019 RANITIDINE HYDROCHLORIDE
ANDA #211289		 SUPPL-1 RANITIDINE HYDROCHLORIDE VKT PHARMA Manufacturing (CMC) Approval
08/08/2019 TIKOSYN
NDA #020931		 SUPPL-17 DOFETILIDE PFIZER Labeling Approval
08/08/2019 SIMVASTATIN
ANDA #078103		 SUPPL-39 SIMVASTATIN LUPIN Labeling Approval
08/08/2019 SIMVASTATIN
ANDA #078103		 SUPPL-43 SIMVASTATIN LUPIN Labeling Approval
08/08/2019 XULTOPHY 100/3.6
BLA #208583		 SUPPL-12 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Approval
08/08/2019 EXEMESTANE
ANDA #208764		 ORIG-1 EXEMESTANE DR REDDYS LABS SA Approval
08/08/2019 ZOLEDRONIC ACID
ANDA #209578		 ORIG-1 ZOLEDRONIC ACID GLAND PHARMA LTD Approval
08/08/2019 CLENPIQ
NDA #209589		 SUPPL-5 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Efficacy Approval
08/08/2019 POTASSIUM CHLORIDE
ANDA #210766		 SUPPL-2 POTASSIUM CHLORIDE PHARM ASSOC Labeling Approval
08/09/2019 SINGULAIR
NDA #020829		 SUPPL-72 MONTELUKAST SODIUM ORGANON Labeling Approval
08/09/2019 SINGULAIR
NDA #020830		 SUPPL-74 MONTELUKAST SODIUM ORGANON Labeling Approval
08/09/2019 SINGULAIR
NDA #021409		 SUPPL-50 MONTELUKAST SODIUM ORGANON Labeling Approval
08/09/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-77 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/09/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-29 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/09/2019 SIRTURO
NDA #204384		 SUPPL-10 BEDAQUILINE FUMARATE JANSSEN THERAP Efficacy Approval
08/09/2019 SAVAYSA
NDA #206316		 SUPPL-15 EDOXABAN TOSYLATE DAIICHI SANKYO INC Efficacy Approval
08/09/2019 VANCOMYCIN HYDROCHLORIDE
NDA #209481		 SUPPL-5 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/09/2019 FENOFIBRATE
ANDA #210476		 ORIG-1 FENOFIBRATE ALEMBIC Approval
08/09/2019 TRAMADOL HYDROCHLORIDE
ANDA #211825		 ORIG-1 TRAMADOL HYDROCHLORIDE UNICHEM Approval
08/09/2019 LEVETIRACETAM
ANDA #211954		 ORIG-1 LEVETIRACETAM MICRO LABS Approval
08/09/2019 DORZOLAMIDE HYDROCHLORIDE
ANDA #212639		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE ALEMBIC Approval
08/12/2019 JANUVIA
NDA #021995		 SUPPL-45 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Efficacy Approval
08/12/2019 JANUMET
NDA #022044		 SUPPL-46 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Efficacy Approval
08/12/2019 DULERA
NDA #022518		 SUPPL-26 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Efficacy Approval
08/12/2019 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-55 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
08/12/2019 TEMAZEPAM
ANDA #071174		 SUPPL-24 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 TEMAZEPAM
ANDA #071174		 SUPPL-25 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 TEMAZEPAM
ANDA #071175		 SUPPL-25 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 TEMAZEPAM
ANDA #071175		 SUPPL-26 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-26 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
08/12/2019 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-28 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
08/12/2019 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-30 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
08/12/2019 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-31 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
08/12/2019 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-32 HALOPERIDOL DECANOATE TEVA PHARMS USA Manufacturing (CMC) Approval
08/12/2019 TEMAZEPAM
ANDA #078581		 SUPPL-7 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 TEMAZEPAM
ANDA #078581		 SUPPL-8 TEMAZEPAM SUN PHARM INDUSTRIES Labeling Approval
08/12/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #079079		 ORIG-1 LAMIVUDINE; ZIDOVUDINE MYLAN LABS LTD Approval
08/12/2019 EYLEA
BLA #125387		 SUPPL-60 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
08/12/2019 JANUMET XR
NDA #202270		 SUPPL-19 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Efficacy Approval
08/12/2019 ASMANEX HFA
NDA #205641		 SUPPL-10 MOMETASONE FUROATE ORGANON LLC Efficacy Approval
08/12/2019 XIGDUO XR
NDA #205649		 SUPPL-12 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) Tentative Approval
08/12/2019 BUSULFAN
ANDA #208536		 SUPPL-1 BUSULFAN MYLAN INSTITUTIONAL Labeling Approval
08/12/2019 BUSULFAN
ANDA #208536		 SUPPL-2 BUSULFAN MYLAN INSTITUTIONAL Labeling Approval
08/12/2019 HALCINONIDE
ANDA #211027		 ORIG-1 HALCINONIDE MYLAN Approval
08/13/2019 HUMALOG
BLA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Approval
08/13/2019 HUMALOG KWIKPEN
BLA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Approval
08/13/2019 HUMALOG PEN
BLA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Approval
08/13/2019 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Approval
08/13/2019 METRONIDAZOLE
ANDA #070035		 SUPPL-59 METRONIDAZOLE WATSON LABS Labeling Approval
08/13/2019 VORAXAZE
BLA #125327		 SUPPL-64 GLUCARPIDASE BTG INTERNATIONAL INC Approval
08/13/2019 ERLOTINIB
ANDA #203843		 ORIG-1 ERLOTINIB WEST WARD PHARM CORP Tentative Approval
08/13/2019 FESOTERODINE FUMARATE
ANDA #204975		 ORIG-1 FESOTERODINE FUMARATE DR REDDYS Approval
08/13/2019 HUMALOG KWIKPEN
BLA #205747		 SUPPL-21 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
08/13/2019 METRONIDAZOLE
ANDA #206560		 SUPPL-2 METRONIDAZOLE CADILA Labeling Approval
08/13/2019 METRONIDAZOLE
ANDA #209794		 SUPPL-1 METRONIDAZOLE CADILA PHARMS LTD Labeling Approval
08/13/2019 ROCURONIUM BROMIDE
ANDA #210437		 ORIG-1 ROCURONIUM BROMIDE PIRAMAL CRITICAL Approval
08/13/2019 PILOCARPINE HYDROCHLORIDE
ANDA #212377		 ORIG-1 PILOCARPINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/14/2019 LAMICTAL
NDA #020241		 SUPPL-59 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/14/2019 LAMICTAL CD
NDA #020764		 SUPPL-52 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/14/2019 NEOPROFEN
NDA #021903		 SUPPL-11 IBUPROFEN LYSINE RECORDATI RARE Labeling Approval
08/14/2019 LAMICTAL XR
NDA #022115		 SUPPL-25 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/14/2019 LAMICTAL ODT
NDA #022251		 SUPPL-23 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #070027		 SUPPL-43 METRONIDAZOLE TEVA PHARMS USA Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #070027		 SUPPL-44 METRONIDAZOLE TEVA PHARMS USA Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #070033		 SUPPL-43 METRONIDAZOLE PLIVA Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #070033		 SUPPL-44 METRONIDAZOLE PLIVA Labeling Approval
08/14/2019 TRANEXAMIC ACID
ANDA #091596		 SUPPL-4 TRANEXAMIC ACID FRESENIUS KABI USA Labeling Approval
08/14/2019 BOSULIF
NDA #203341		 SUPPL-16 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #203458		 SUPPL-3 METRONIDAZOLE UNICHEM Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #203458		 SUPPL-6 METRONIDAZOLE UNICHEM Labeling Approval
08/14/2019 AMMONIA N 13
ANDA #203783		 SUPPL-2 AMMONIA N-13 BRIGHAM WOMENS HOSP Manufacturing (CMC) Approval
08/14/2019 NEVIRAPINE
ANDA #204621		 SUPPL-4 NEVIRAPINE ALVOGEN Labeling Approval
08/14/2019 NEVIRAPINE
ANDA #204621		 SUPPL-5 NEVIRAPINE ALVOGEN Labeling Approval
08/14/2019 NEVIRAPINE
ANDA #206448		 SUPPL-1 NEVIRAPINE CIPLA Labeling Approval
08/14/2019 NEVIRAPINE
ANDA #206448		 SUPPL-3 NEVIRAPINE CIPLA Labeling Approval
08/14/2019 NEVIRAPINE
ANDA #206448		 SUPPL-5 NEVIRAPINE CIPLA Labeling Approval
08/14/2019 NEVIRAPINE
ANDA #206879		 SUPPL-6 NEVIRAPINE MACLEODS PHARMS LTD Labeling Approval
08/14/2019 ESMOLOL HYDROCHLORIDE
ANDA #208538		 ORIG-1 ESMOLOL HYDROCHLORIDE GLAND PHARMA LTD Approval
08/14/2019 WAKIX
NDA #211150		 ORIG-1 PITOLISANT HYDROCHLORIDE HARMONY Type 1 - New Molecular Entity Approval
08/14/2019 LEVOCARNITINE
ANDA #211676		 ORIG-1 LEVOCARNITINE NOVITIUM PHARMA Approval
08/14/2019 LEVOCARNITINE SF
ANDA #211676		 ORIG-1 LEVOCARNITINE NOVITIUM PHARMA Approval
08/14/2019 PRETOMANID
NDA #212862		 ORIG-1 PRETOMANID MYLAN IRELAND LTD Type 1 - New Molecular Entity Approval
08/15/2019 PEPCID
NDA #019527		 SUPPL-31 FAMOTIDINE SALIX PHARMS Labeling Approval
08/15/2019 FUZEON
NDA #021481		 SUPPL-33 ENFUVIRTIDE ROCHE Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-23 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-24 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-28 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-18 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-19 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-22 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
08/15/2019 FENOFIBRATE
ANDA #202856		 SUPPL-9 FENOFIBRATE MYLAN PHARMS INC Labeling Approval
08/15/2019 SIRTURO
NDA #204384		 SUPPL-12 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
08/15/2019 OXYCODONE AND ACETAMINOPHEN
ANDA #207834		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CHARTWELL Approval
08/15/2019 CLOMIPRAMINE HYDROCHLORIDE
ANDA #209294		 SUPPL-1 CLOMIPRAMINE HYDROCHLORIDE LUPIN LTD Labeling Approval
08/15/2019 FENOFIBRATE
ANDA #210138		 SUPPL-2 FENOFIBRATE AJANTA PHARMA LTD Labeling Approval
08/15/2019 FENOFIBRATE
ANDA #210138		 SUPPL-3 FENOFIBRATE AJANTA PHARMA LTD Labeling Approval
08/15/2019 HYDROCORTISONE VALERATE
ANDA #210307		 ORIG-1 HYDROCORTISONE VALERATE LUPIN LTD Approval
08/15/2019 ROZLYTREK
NDA #212725		 ORIG-1 ENTRECTINIB GENENTECH INC Type 1 - New Molecular Entity Approval
08/15/2019 ROZLYTREK
NDA #212726		 ORIG-1 ENTRECTINIB GENENTECH INC Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
08/16/2019 METHOTREXATE SODIUM
NDA #008085		 SUPPL-63 METHOTREXATE SODIUM STRIDES PHARMA Manufacturing (CMC) Approval
08/16/2019 FOSAMAX
NDA #020560		 SUPPL-70 ALENDRONATE SODIUM ORGANON Labeling Approval
08/16/2019 SOMAVERT
BLA #021106		 SUPPL-55 PEGVISOMANT PHARMACIA Approval
08/16/2019 FOSAMAX PLUS D
NDA #021762		 SUPPL-22 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
08/16/2019 GILENYA
NDA #022527		 SUPPL-29 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
08/16/2019 GILENYA
NDA #022527		 SUPPL-30 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
08/16/2019 AMPICILLIN SODIUM
ANDA #062692		 SUPPL-1 AMPICILLIN SODIUM HIKMA Labeling Approval
08/16/2019 CLINDAMYCIN PHOSPHATE
ANDA #065184		 SUPPL-9 CLINDAMYCIN PHOSPHATE TARO PHARM INDS Labeling Approval
08/16/2019 ACETAMINOPHEN
ANDA #075077		 SUPPL-55 ACETAMINOPHEN PERRIGO Labeling Approval
08/16/2019 ABACAVIR SULFATE
ANDA #077844		 SUPPL-12 ABACAVIR SULFATE AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 ABACAVIR SULFATE
ANDA #077844		 SUPPL-13 ABACAVIR SULFATE AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 ABACAVIR SULFATE
ANDA #077844		 SUPPL-14 ABACAVIR SULFATE AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 ABACAVIR SULFATE
ANDA #077950		 SUPPL-9 ABACAVIR SULFATE AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 BETASERON
BLA #103471		 SUPPL-5195 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
08/16/2019 VALSARTAN
ANDA #202223		 SUPPL-5 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 VALSARTAN
ANDA #202223		 SUPPL-6 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 VALSARTAN
ANDA #202223		 SUPPL-11 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519		 SUPPL-5 HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519		 SUPPL-12 HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
08/16/2019 INDOMETHACIN
ANDA #203501		 SUPPL-1 INDOMETHACIN GLENMARK PHARMS LTD Labeling Approval
08/16/2019 IRBESARTAN
ANDA #204774		 SUPPL-8 IRBESARTAN SCIEGEN PHARMS INC Labeling Approval
08/16/2019 DULOXETINE HYDROCHLORIDE
ANDA #207219		 ORIG-1 DULOXETINE HYDROCHLORIDE YAOPHARMA CO LTD Approval
08/16/2019 TEMSIROLIMUS
ANDA #207383		 ORIG-1 TEMSIROLIMUS GLAND PHARMA LTD Approval
08/16/2019 TRAVOPROST
ANDA #210445		 ORIG-1 TRAVOPROST APOTEX INC Tentative Approval
08/16/2019 MEROPENEM
ANDA #210773		 ORIG-1 MEROPENEM HQ SPCLT PHARMA Approval
08/16/2019 LEVOLEUCOVORIN CALCIUM
ANDA #211002		 ORIG-1 LEVOLEUCOVORIN CALCIUM MEITHEAL Approval
08/16/2019 RINVOQ
NDA #211675		 ORIG-1 UPADACITINIB ABBVIE Type 1 - New Molecular Entity Approval
08/16/2019 INREBIC
NDA #212327		 ORIG-1 FEDRATINIB HYDROCHLORIDE BRISTOL-MYERS Type 1 - New Molecular Entity Approval
08/18/2019 AMBIEN
NDA #019908		 SUPPL-46 ZOLPIDEM TARTRATE SANOFI AVENTIS US Labeling Approval
08/18/2019 SONATA
NDA #020859		 SUPPL-16 ZALEPLON PFIZER Labeling Approval
08/18/2019 LUNESTA
NDA #021476		 SUPPL-38 ESZOPICLONE WAYLIS THERAP Labeling Approval
08/18/2019 AMBIEN CR
NDA #021774		 SUPPL-27 ZOLPIDEM TARTRATE SANOFI AVENTIS US Labeling Approval
08/18/2019 EDLUAR
NDA #021997		 SUPPL-11 ZOLPIDEM TARTRATE MYLAN SPECIALITY LP Labeling Approval
08/18/2019 ZOLPIMIST
NDA #022196		 SUPPL-12 ZOLPIDEM TARTRATE AYTU Labeling Approval
08/18/2019 INTERMEZZO
NDA #022328		 SUPPL-8 ZOLPIDEM TARTRATE PURDUE PHARMA Labeling Approval
08/18/2019 HELIUM, USP
NDA #213727		 ORIG-1 HELIUM A G L WELDING SUPPLY CO INC Medical Gas Approval
08/19/2019 ZELAPAR
NDA #021479		 SUPPL-8 SELEGILINE HYDROCHLORIDE BAUSCH Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-28 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-29 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-32 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-33 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-44 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065194		 SUPPL-5 CLINDAMYCIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065194		 SUPPL-6 CLINDAMYCIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065194		 SUPPL-8 CLINDAMYCIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065194		 SUPPL-9 CLINDAMYCIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065194		 SUPPL-10 CLINDAMYCIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065217		 SUPPL-3 CLINDAMYCIN HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065217		 SUPPL-4 CLINDAMYCIN HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065217		 SUPPL-5 CLINDAMYCIN HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065217		 SUPPL-6 CLINDAMYCIN HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-8 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-9 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-11 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-12 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/19/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-15 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #076702		 SUPPL-15 OXYBUTYNIN CHLORIDE MYLAN Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #076702		 SUPPL-16 OXYBUTYNIN CHLORIDE MYLAN Labeling Approval
08/19/2019 PANTOPRAZOLE SODIUM
ANDA #077674		 ORIG-1 PANTOPRAZOLE SODIUM SUN PHARM Approval
08/19/2019 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090245		 SUPPL-8 AMLODIPINE BESYLATE; VALSARTAN LUPIN Labeling Approval
08/19/2019 ALENDRONATE SODIUM
ANDA #090520		 SUPPL-4 ALENDRONATE SODIUM HIKMA Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-9 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-10 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-12 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-14 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-16 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-17 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #202332		 SUPPL-3 OXYBUTYNIN CHLORIDE ZYDUS PHARMS Labeling Approval
08/19/2019 ACETYLCYSTEINE
ANDA #203173		 SUPPL-1 ACETYLCYSTEINE RISING Labeling Approval
08/19/2019 ACETYLCYSTEINE
ANDA #203173		 SUPPL-2 ACETYLCYSTEINE RISING Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #204010		 SUPPL-2 OXYBUTYNIN CHLORIDE AMNEAL PHARMS Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #204010		 SUPPL-7 OXYBUTYNIN CHLORIDE AMNEAL PHARMS Labeling Approval
08/19/2019 TOLTERODINE TARTRATE
ANDA #204562		 ORIG-1 TOLTERODINE TARTRATE INVENTIA HLTHCARE Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #206121		 SUPPL-2 OXYBUTYNIN CHLORIDE UNIQUE Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #206121		 SUPPL-3 OXYBUTYNIN CHLORIDE UNIQUE Labeling Approval
08/19/2019 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #206575		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TARO Approval
08/19/2019 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #207194		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ENCUBE Approval
08/19/2019 TAFLUPROST
ANDA #209051		 ORIG-1 TAFLUPROST MICRO LABS Approval
08/19/2019 FULVESTRANT
NDA #210063		 ORIG-1 FULVESTRANT TEVA PHARMS USA INC Type 5 - New Formulation or New Manufacturer Approval
08/19/2019 RANOLAZINE
ANDA #210188		 ORIG-1 RANOLAZINE CADILA Approval
08/19/2019 TRIAMTERENE
ANDA #211581		 ORIG-1 TRIAMTERENE AGNITIO Approval
08/19/2019 XENLETA
NDA #211672		 ORIG-1 LEFAMULIN ACETATE NABRIVA Type 1 - New Molecular Entity Approval
08/19/2019 XENLETA
NDA #211673		 ORIG-1 LEFAMULIN ACETATE NABRIVA Type 1 - New Molecular Entity Approval
08/19/2019 MIDODRINE HYDROCHLORIDE
ANDA #212543		 ORIG-1 MIDODRINE HYDROCHLORIDE RUBICON Approval
08/20/2019 TARKA
NDA #020591		 SUPPL-30 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE ABBVIE Labeling Approval
08/20/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243		 SUPPL-20 CLINDAMYCIN HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
08/20/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243		 SUPPL-23 CLINDAMYCIN HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
08/20/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-18 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
08/20/2019 VALSARTAN
ANDA #077492		 SUPPL-6 VALSARTAN OHM LABS INC Labeling Approval
08/20/2019 VALSARTAN
ANDA #077492		 SUPPL-11 VALSARTAN OHM LABS INC Labeling Approval
08/20/2019 VALSARTAN
ANDA #077492		 SUPPL-12 VALSARTAN OHM LABS INC Labeling Approval
08/20/2019 MYOBLOC
BLA #103846		 SUPPL-5190 Botulinum Toxin Type B ELAN PHARM Approval
08/20/2019 CHOLESTYRAMINE
ANDA #202901		 SUPPL-3 CHOLESTYRAMINE ZYDUS PHARMS Manufacturing (CMC) Approval
08/20/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145		 SUPPL-24 HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD Labeling Approval
08/20/2019 SAPROPTERIN DIHYDROCHLORIDE
ANDA #207207		 ORIG-1 SAPROPTERIN DIHYDROCHLORIDE PAR PHARM INC Approval
08/20/2019 CELECOXIB
ANDA #207446		 SUPPL-3 CELECOXIB CIPLA Labeling Approval
08/20/2019 CELECOXIB
ANDA #207446		 SUPPL-4 CELECOXIB CIPLA Labeling Approval
08/20/2019 CELECOXIB
ANDA #207446		 SUPPL-7 CELECOXIB CIPLA Labeling Approval
08/20/2019 CELECOXIB
ANDA #207677		 SUPPL-2 CELECOXIB TORRENT Labeling Approval
08/20/2019 CELECOXIB
ANDA #207677		 SUPPL-3 CELECOXIB TORRENT Labeling Approval
08/20/2019 VALSARTAN
ANDA #209261		 SUPPL-2 VALSARTAN UNICHEM Labeling Approval
08/20/2019 SAPROPTERIN DIHYDROCHLORIDE
ANDA #210027		 ORIG-1 SAPROPTERIN DIHYDROCHLORIDE PAR PHARM INC Approval
08/20/2019 QMIIZ ODT
NDA #211210		 SUPPL-1 MELOXICAM TERSERA Manufacturing (CMC) Approval
08/21/2019 NORVIR
NDA #020659		 SUPPL-70 RITONAVIR ABBVIE Labeling Approval
08/21/2019 NORVIR
NDA #020945		 SUPPL-46 RITONAVIR ABBVIE Labeling Approval
08/21/2019 KALETRA
NDA #021226		 SUPPL-47 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
08/21/2019 KALETRA
NDA #021251		 SUPPL-57 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
08/21/2019 KALETRA
NDA #021906		 SUPPL-52 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
08/21/2019 NORVIR
NDA #022417		 SUPPL-22 RITONAVIR ABBVIE Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #077702		 SUPPL-12 NEVIRAPINE AUROBINDO Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #077702		 SUPPL-13 NEVIRAPINE AUROBINDO Labeling Approval
08/21/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #202261		 ORIG-4 MINOCYCLINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/21/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #203443		 ORIG-2 MINOCYCLINE HYDROCHLORIDE RISING Approval
08/21/2019 ACETYLCYSTEINE
ANDA #203624		 SUPPL-2 ACETYLCYSTEINE RISING Labeling Approval
08/21/2019 ACETYLCYSTEINE
ANDA #203624		 SUPPL-3 ACETYLCYSTEINE RISING Labeling Approval
08/21/2019 VARITHENA
NDA #205098		 SUPPL-31 POLIDOCANOL PROVENSIS Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #205651		 SUPPL-2 NEVIRAPINE MYLAN Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #205651		 SUPPL-3 NEVIRAPINE MYLAN Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #205651		 SUPPL-6 NEVIRAPINE MYLAN Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #206271		 SUPPL-2 NEVIRAPINE MYLAN Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #206271		 SUPPL-5 NEVIRAPINE MYLAN Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #207698		 SUPPL-2 NEVIRAPINE AUROBINDO PHARMA Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #207698		 SUPPL-4 NEVIRAPINE AUROBINDO PHARMA Labeling Approval
08/21/2019 TICAGRELOR
ANDA #208531		 SUPPL-1 TICAGRELOR AMNEAL Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #208616		 SUPPL-2 NEVIRAPINE AUROBINDO PHARMA Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #208616		 SUPPL-4 NEVIRAPINE AUROBINDO PHARMA Labeling Approval
08/21/2019 NORVIR
NDA #209512		 SUPPL-5 RITONAVIR ABBVIE Labeling Approval
08/21/2019 GALLIUM GA 68 EDOTREOTIDE
NDA #210828		 ORIG-1 GALLIUM GA-68 EDOTREOTIDE UIHC PET IMAGING Type 1 - New Molecular Entity Approval
08/21/2019 VORTIOXETINE
ANDA #211089		 ORIG-1 VORTIOXETINE ALKEM LABS LTD Tentative Approval
08/21/2019 DAPAGLIFLOZIN
ANDA #211416		 ORIG-1 DAPAGLIFLOZIN SUN PHARM INDS LTD Tentative Approval
08/21/2019 POSACONAZOLE
ANDA #212411		 ORIG-1 POSACONAZOLE SINOTHERAPEUTICS INC Approval
08/22/2019 DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016678		 SUPPL-107 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
08/22/2019 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016683		 SUPPL-103 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
08/22/2019 DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #016687		 SUPPL-104 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
08/22/2019 DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #016689		 SUPPL-107 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
08/22/2019 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016697		 SUPPL-98 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
08/22/2019 HUMULIN R
BLA #018780		 SUPPL-172 INSULIN HUMAN LILLY Approval
08/22/2019 HUMULIN R
BLA #018780		 SUPPL-172 INSULIN RECOMBINANT HUMAN LILLY Approval
08/22/2019 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-172 INSULIN HUMAN LILLY Approval
08/22/2019 HUMULIN R PEN
BLA #018780		 SUPPL-172 INSULIN RECOMBINANT HUMAN LILLY Approval
08/22/2019 HUMULIN N
BLA #018781		 SUPPL-184 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/22/2019 HUMULIN 70/30
BLA #019717		 SUPPL-165 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/22/2019 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-165 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
08/22/2019 SIMVASTATIN
ANDA #078155		 SUPPL-32 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
08/22/2019 SIMVASTATIN
ANDA #090383		 SUPPL-10 SIMVASTATIN MICRO LABS Labeling Approval
08/22/2019 DOXERCALCIFEROL
ANDA #200926		 SUPPL-5 DOXERCALCIFEROL SANDOZ Labeling Approval
08/22/2019 TYBOST
NDA #203094		 SUPPL-13 COBICISTAT GILEAD SCIENCES INC Efficacy Approval
08/22/2019 FULVESTRANT
ANDA #205871		 ORIG-1 FULVESTRANT SAGENT PHARMS INC Approval
08/22/2019 METHADONE HYDROCHLORIDE
ANDA #207368		 ORIG-1 METHADONE HYDROCHLORIDE SPECGX LLC Approval
08/22/2019 FULVESTRANT
ANDA #207754		 ORIG-1 FULVESTRANT GLENMARK PHARMS INC Approval
08/22/2019 GALAFOLD
NDA #208623		 SUPPL-1 MIGALASTAT HYDROCHLORIDE AMICUS THERAP US Labeling Approval
08/22/2019 LEVOLEUCOVORIN CALCIUM
ANDA #211003		 ORIG-1 LEVOLEUCOVORIN CALCIUM MEITHEAL Approval
08/22/2019 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #211830		 ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM COREPHARMA Approval
08/22/2019 DAPTOMYCIN
ANDA #212022		 ORIG-1 DAPTOMYCIN HENGRUI PHARMA Approval
08/23/2019 LETAIRIS
NDA #022081		 SUPPL-41 AMBRISENTAN GILEAD Labeling Approval
08/23/2019 XARELTO
NDA #022406		 SUPPL-34 RIVAROXABAN JANSSEN PHARMS Labeling Approval
08/23/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076604		 SUPPL-22 HYDROCODONE BITARTRATE; IBUPROFEN ACTAVIS LABS FL INC Labeling Approval
08/23/2019 TALTZ
BLA #125521		 SUPPL-16 IXEKIZUMAB ELI LILLY AND CO Approval
08/23/2019 XARELTO
NDA #202439		 SUPPL-32 RIVAROXABAN JANSSEN PHARMS Labeling Approval
08/23/2019 RALOXIFENE HYDROCHLORIDE
ANDA #204310		 SUPPL-5 RALOXIFENE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/23/2019 RALOXIFENE HYDROCHLORIDE
ANDA #204491		 SUPPL-1 RALOXIFENE HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
08/23/2019 RALOXIFENE HYDROCHLORIDE
ANDA #206384		 SUPPL-4 RALOXIFENE HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
08/23/2019 RALOXIFENE HYDROCHLORIDE
ANDA #208206		 SUPPL-2 RALOXIFENE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
08/23/2019 AZELASTINE HYDROCHLORIDE
ANDA #210032		 ORIG-1 AZELASTINE HYDROCHLORIDE AKORN Approval
08/23/2019 AZELAIC ACID
ANDA #210549		 ORIG-1 AZELAIC ACID TARO Approval
08/23/2019 VORTIOXETINE
ANDA #211085		 ORIG-1 VORTIOXETINE CIPLA LTD Tentative Approval
08/23/2019 AMINOCAPROIC ACID
ANDA #212780		 ORIG-1 AMINOCAPROIC ACID AMNEAL Approval
08/26/2019 MEDROL
NDA #011153		 SUPPL-77 METHYLPREDNISOLONE PFIZER Manufacturing (CMC) Approval
08/26/2019 SEROQUEL
NDA #020639		 SUPPL-66 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
08/26/2019 SEROQUEL XR
NDA #022047		 SUPPL-40 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
08/26/2019 BICILLIN C-R
NDA #050138		 SUPPL-241 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
08/26/2019 BICILLIN C-R 900/300
NDA #050138		 SUPPL-241 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
08/26/2019 TEMAZEPAM
ANDA #070920		 SUPPL-30 TEMAZEPAM AUROBINDO PHARMA USA Labeling Approval
08/26/2019 TEMAZEPAM
ANDA #070920		 SUPPL-32 TEMAZEPAM AUROBINDO PHARMA USA Labeling Approval
08/26/2019 TRANDOLAPRIL
ANDA #077522		 SUPPL-14 TRANDOLAPRIL LUPIN Labeling Approval
08/26/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199		 SUPPL-14 LEVOCETIRIZINE DIHYDROCHLORIDE TEVA PHARMS Labeling Approval
08/26/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199		 SUPPL-15 LEVOCETIRIZINE DIHYDROCHLORIDE TEVA PHARMS Labeling Approval
08/26/2019 REGRANEX
BLA #103691		 SUPPL-5138 BECAPLERMIN SMITH AND NEPHEW Approval
08/26/2019 NITISINONE
ANDA #211041		 ORIG-1 NITISINONE NOVITIUM PHARMA Approval
08/26/2019 IMFINZI
BLA #761069		 SUPPL-16 DURVALUMAB ASTRAZENECA UK LTD Approval
08/27/2019 NOURIANZ
NDA #022075		 ORIG-1 ISTRADEFYLLINE KYOWA KIRIN Type 1 - New Molecular Entity Approval
08/27/2019 RIFADIN
NDA #050420		 SUPPL-83 RIFAMPIN SANOFI AVENTIS US Labeling Approval
08/27/2019 RIFADIN
NDA #050627		 SUPPL-25 RIFAMPIN SANOFI AVENTIS US Labeling Approval
08/27/2019 RIFATER
NDA #050705		 SUPPL-17 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
08/27/2019 TEMAZEPAM
ANDA #071457		 SUPPL-14 TEMAZEPAM NOVEL LABS INC Labeling Approval
08/27/2019 OXAPROZIN
ANDA #075845		 SUPPL-20 OXAPROZIN SANDOZ Labeling Approval
08/27/2019 OXAPROZIN
ANDA #075845		 SUPPL-22 OXAPROZIN SANDOZ Labeling Approval
08/27/2019 OXAPROZIN
ANDA #075849		 SUPPL-7 OXAPROZIN TEVA Labeling Approval
08/27/2019 OXAPROZIN
ANDA #075849		 SUPPL-8 OXAPROZIN TEVA Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #077558		 SUPPL-16 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #077558		 SUPPL-18 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #077880		 SUPPL-21 METFORMIN HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #077880		 SUPPL-22 METFORMIN HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #078596		 SUPPL-15 METFORMIN HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #078596		 SUPPL-17 METFORMIN HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #090666		 SUPPL-1 METFORMIN HYDROCHLORIDE APOTEX Labeling Approval
08/27/2019 METFORMIN HYDROCHLORIDE
ANDA #090666		 SUPPL-2 METFORMIN HYDROCHLORIDE APOTEX Labeling Approval
08/27/2019 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #090834		 SUPPL-5 OCTREOTIDE ACETATE SAGENT PHARMS INC Labeling Approval
08/27/2019 OCTREOTIDE ACETATE
ANDA #091041		 SUPPL-5 OCTREOTIDE ACETATE SAGENT PHARMS INC Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-2 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-6 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-7 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-8 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 SUPPL-9 LAMIVUDINE; ZIDOVUDINE MYLAN Labeling Approval
08/27/2019 ARGATROBAN
ANDA #204120		 SUPPL-3 ARGATROBAN HOSPIRA Labeling Approval
08/27/2019 ETHACRYNIC ACID
ANDA #211232		 ORIG-1 ETHACRYNIC ACID SCIEGEN PHARMS INC Approval
08/27/2019 SOLIFENACIN SUCCINATE
ANDA #211701		 ORIG-1 SOLIFENACIN SUCCINATE UNICHEM Approval
08/28/2019 METFORMIN HYDROCHLORIDE
ANDA #075965		 SUPPL-17 METFORMIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/28/2019 METFORMIN HYDROCHLORIDE
ANDA #075965		 SUPPL-18 METFORMIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
08/28/2019 SOVALDI
NDA #204671		 SUPPL-14 SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
08/28/2019 HARVONI
NDA #205834		 SUPPL-29 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
08/28/2019 DOXERCALCIFEROL
NDA #208614		 SUPPL-2 DOXERCALCIFEROL HOSPIRA Labeling Approval
08/28/2019 ORILISSA
NDA #210450		 SUPPL-2 ELAGOLIX SODIUM ABBVIE Labeling Approval
08/28/2019 DECITABINE
ANDA #212265		 ORIG-1 DECITABINE MSN Approval
08/28/2019 HARVONI
NDA #212477		 ORIG-1 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Type 3 - New Dosage Form Approval
08/28/2019 SOVALDI
NDA #212480		 ORIG-1 SOFOSBUVIR GILEAD SCIENCES INC Type 3 - New Dosage Form Approval
08/29/2019 NICOTROL
NDA #020385		 SUPPL-11 NICOTINE PFIZER INC Labeling Approval
08/29/2019 NICOTROL
NDA #020714		 SUPPL-18 NICOTINE PFIZER Labeling Approval
08/29/2019 ASCLERA
NDA #021201		 SUPPL-4 POLIDOCANOL CHEMISCH FBRK KRSSLR Labeling Approval
08/29/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065498		 SUPPL-9 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
08/29/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065498		 SUPPL-14 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695		 SUPPL-10 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695		 SUPPL-11 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695		 SUPPL-12 LAMIVUDINE AUROBINDO PHARMA Labeling Approval
08/29/2019 NEVIRAPINE
ANDA #203411		 SUPPL-4 NEVIRAPINE SANDOZ Labeling Approval
08/29/2019 NEVIRAPINE
ANDA #203411		 SUPPL-5 NEVIRAPINE SANDOZ Labeling Approval
08/29/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646		 SUPPL-10 LEVOCETIRIZINE DIHYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
08/29/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646		 SUPPL-12 LEVOCETIRIZINE DIHYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
08/29/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646		 SUPPL-16 LEVOCETIRIZINE DIHYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
08/29/2019 INBRIJA
NDA #209184		 SUPPL-1 LEVODOPA ACORDA Labeling Approval
08/29/2019 PREVYMIS
NDA #209939		 SUPPL-5 LETERMOVIR MERCK SHARP DOHME Labeling Approval
08/29/2019 PREVYMIS
NDA #209940		 SUPPL-3 LETERMOVIR MERCK SHARP DOHME Labeling Approval
08/29/2019 VENLAFAXINE HYDROCHLORIDE
ANDA #211323		 ORIG-1 VENLAFAXINE HYDROCHLORIDE CADILA PHARMS LTD Approval
08/29/2019 PIMECROLIMUS
ANDA #211769		 ORIG-1 PIMECROLIMUS GLENMARK PHARMS LTD Approval
08/29/2019 RIOMET ER
NDA #212595		 ORIG-1 METFORMIN HYDROCHLORIDE SUN PHARM Type 3 - New Dosage Form Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-13 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-20 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-25 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065458		 SUPPL-4 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM STERISCIENCE Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065458		 SUPPL-6 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM STERISCIENCE Labeling Approval
08/30/2019 NABUMETONE
ANDA #203166		 ORIG-1 NABUMETONE LGM PHARMA Approval
08/30/2019 XELJANZ
NDA #203214		 SUPPL-23 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-11 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-17 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/30/2019 MEROPENEM
ANDA #204854		 SUPPL-1 MEROPENEM DAEWOONG PHARM CO Labeling Approval
08/30/2019 MEROPENEM
ANDA #204854		 SUPPL-4 MEROPENEM DAEWOONG PHARM CO Labeling Approval
08/30/2019 MEROPENEM
ANDA #204854		 SUPPL-5 MEROPENEM DAEWOONG PHARM CO Labeling Approval
08/30/2019 MEROPENEM
ANDA #205835		 SUPPL-2 MEROPENEM EUGIA PHARMA Labeling Approval
08/30/2019 MEROPENEM
ANDA #205835		 SUPPL-3 MEROPENEM EUGIA PHARMA Labeling Approval
08/30/2019 XELJANZ XR
NDA #208246		 SUPPL-11 TOFACITINIB CITRATE PFIZER Labeling Approval
08/30/2019 ERTAPENEM SODIUM
ANDA #209133		 SUPPL-1 ERTAPENEM SODIUM EUGIA PHARMA Labeling Approval
08/30/2019 RANITIDINE HYDROCHLORIDE
ANDA #210228		 ORIG-1 RANITIDINE HYDROCHLORIDE THINQ PHARM-CRO PVT Approval
08/30/2019 RANITIDINE HYDROCHLORIDE
ANDA #210250		 ORIG-1 RANITIDINE HYDROCHLORIDE THINQ PHARM-CRO PVT Approval
08/30/2019 OFLOXACIN
ANDA #211525		 ORIG-1 OFLOXACIN AMNEAL Approval
08/30/2019 NAPROXEN SODIUM
ANDA #212033		 ORIG-1 NAPROXEN SODIUM YICHANG HUMANWELL Approval
08/31/2019 GLYCOPYRROLATE
ANDA #090963		 SUPPL-12 GLYCOPYRROLATE HIKMA FARMACEUTICA Labeling Approval
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