Drugs@FDA: FDA Approved Drug Products

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All Approvals
August 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on August 19, 2019.

 

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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 KINEDEXE UK Approval
08/01/2019 SILDENAFIL
ANDA #211534		 ORIG-1 SILDENAFIL TEVA PHARMS USA INC Tentative 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 IDAMYCIN
NDA #050661		 SUPPL-15 IDARUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
08/02/2019 IDAMYCIN PFS
NDA #050734		 SUPPL-25 IDARUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-20 CLOPIDOGREL BISULFATE DR REDDYS LABS INC Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-21 CLOPIDOGREL BISULFATE DR REDDYS LABS INC Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-23 CLOPIDOGREL BISULFATE DR REDDYS LABS INC Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-24 CLOPIDOGREL BISULFATE DR REDDYS LABS INC Labeling Approval
08/02/2019 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-25 CLOPIDOGREL BISULFATE DR REDDYS LABS INC 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 SANDOZ INC Labeling Approval
08/02/2019 FOSAMPRENAVIR CALCIUM
ANDA #204024		 ORIG-1 FOSAMPRENAVIR CALCIUM SUN PHARM INDS LTD Tentative Approval
08/02/2019 EVEROLIMUS
ANDA #207934		 ORIG-1 EVEROLIMUS PAR PHARM INC Tentative Approval
08/02/2019 ITRACONAZOLE
ANDA #208481		 ORIG-1 ITRACONAZOLE APOTEX INC 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-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 NOVELGENIX THERAPS Approval
08/05/2019 APADAZ
NDA #208653		 SUPPL-5 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE KVK TECH INC Labeling Approval
08/05/2019 VINORELBINE TARTRATE
ANDA #208997		 ORIG-1 VINORELBINE TARTRATE INGENUS PHARMS LLC Approval
08/05/2019 AMPHETAMINE SULFATE
ANDA #212619		 ORIG-1 AMPHETAMINE SULFATE GRANULES PHARMS Approval
08/06/2019 CHLORTHALIDONE
ANDA #211627		 ORIG-1 CHLORTHALIDONE UNICHEM LABS LTD 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 GILEAD 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
NDA #021810		 SUPPL-17 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Labeling 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 PHARMS (USA) Labeling Approval
08/07/2019 BENAZEPRIL HYDROCHLORIDE
ANDA #078848		 SUPPL-5 BENAZEPRIL HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
08/07/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-5 HYDROCHLOROTHIAZIDE; IRBESARTAN WEST-WARD PHARMS INT Labeling Approval
08/07/2019 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 SUPPL-8 HYDROCHLOROTHIAZIDE; IRBESARTAN WEST-WARD PHARMS INT 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 BIONPHARMA INC Approval
08/07/2019 CELECOXIB
ANDA #208856		 ORIG-1 CELECOXIB QINGDAO BAHEAL PHARM Approval
08/07/2019 DOXERCALCIFEROL
ANDA #208974		 SUPPL-3 DOXERCALCIFEROL AMNEAL PHARMS CO Labeling Approval
08/07/2019 DOXERCALCIFEROL
ANDA #208975		 SUPPL-3 DOXERCALCIFEROL AMNEAL PHARMS CO 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 PVT LTD 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
NDA #208583		 SUPPL-12 INSULIN DEGLUDEC; LIRAGLUTIDE NOVO Efficacy Approval
08/08/2019 EXEMESTANE
ANDA #208764		 ORIG-1 EXEMESTANE MAYNE PHARMA INC 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
08/08/2019 HYDROXYPROGESTERONE CAPROATE
ANDA #211777		 ORIG-1 HYDROXYPROGESTERONE CAPROATE ASPEN Approval
08/09/2019 SINGULAIR
NDA #020829		 SUPPL-72 MONTELUKAST SODIUM MSD MERCK CO Labeling Approval
08/09/2019 SINGULAIR
NDA #020830		 SUPPL-74 MONTELUKAST SODIUM MSD MERCK CO Labeling Approval
08/09/2019 SINGULAIR
NDA #021409		 SUPPL-50 MONTELUKAST SODIUM MERCK Labeling Approval
08/09/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-77 DOXORUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
08/09/2019 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-29 DOXORUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN 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 OLOPATADINE HYDROCHLORIDE
ANDA #209752		 ORIG-1 OLOPATADINE HYDROCHLORIDE GLAND PHARMA LTD Tentative Approval
08/09/2019 FENOFIBRATE
ANDA #210476		 ORIG-1 FENOFIBRATE ALEMBIC PHARMS LTD Approval
08/09/2019 HYDROXYPROGESTERON CAPROATE
ANDA #210724		 ORIG-1 HYDROXYPROGESTERONE CAPROATE AM REGENT Approval
08/09/2019 TRAMADOL HYDROCHLORIDE
ANDA #211825		 ORIG-1 TRAMADOL HYDROCHLORIDE UNICHEM LABS LTD 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 PHARMS LTD 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 MERCK SHARP DOHME Efficacy Approval
08/12/2019 DULERA
NDA #022518		 SUPPL-26 FORMOTEROL FUMARATE; MOMETASONE FUROATE MERCK SHARP DOHME Efficacy Approval
08/12/2019 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-55 DOXORUBICIN HYDROCHLORIDE JANSSEN RES AND DEV 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 Approval
08/12/2019 JANUMET XR
NDA #202270		 SUPPL-19 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Efficacy Approval
08/12/2019 ASMANEX HFA
NDA #205641		 SUPPL-10 MOMETASONE FUROATE MERCK SHARP DOHME Efficacy Approval
08/12/2019 HALCINONIDE
ANDA #211027		 ORIG-1 HALCINONIDE MYLAN Approval
08/13/2019 HUMALOG
NDA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
08/13/2019 HUMALOG KWIKPEN
NDA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
08/13/2019 HUMALOG PEN
NDA #020563		 SUPPL-195 INSULIN LISPRO RECOMBINANT LILLY Labeling 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 LABS LTD Approval
08/13/2019 HUMALOG KWIKPEN
NDA #205747		 SUPPL-21 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Labeling 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 CAMARGO PHARM 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 LABS LTD Labeling Approval
08/14/2019 METRONIDAZOLE
ANDA #203458		 SUPPL-6 METRONIDAZOLE UNICHEM LABS LTD 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 BIOPROJET PHARMA 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 THE GLOBAL ALLIANCE FOR TB DRUG DEV 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 PHARM Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-24 AMIODARONE HYDROCHLORIDE TARO PHARM Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-28 AMIODARONE HYDROCHLORIDE TARO PHARM Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-18 AMIODARONE HYDROCHLORIDE TARO PHARM Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-19 AMIODARONE HYDROCHLORIDE TARO PHARM Labeling Approval
08/15/2019 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-22 AMIODARONE HYDROCHLORIDE TARO PHARM Labeling Approval
08/15/2019 TRI-LO-LINYAH
ANDA #090541		 ORIG-1 NORGESTIMATE; ETHINYL ESTRADIOL NOVAST LABS LTD Tentative Approval
08/15/2019 SIRTURO
NDA #204384		 SUPPL-12 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
08/15/2019 ROZLYTREK
NDA #212725		 ORIG-1 ENTRECTINIB GENENTECH INC Type 1 - New Molecular Entity Approval
08/16/2019 RINVOQ
NDA #211675		 ORIG-1 UPADACITINIB ABBVIE INC Type 1 - New Molecular Entity Approval
08/16/2019 INREBIC
NDA #212327		 ORIG-1 FEDRATINIB IMPACT BIOMEDICINES INC Type 1 - New Molecular Entity Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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