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 September 18, 2019.

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 HYDROCHLORIDE 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 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 HALO PHARM CANADA 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 1 - New Molecular Entity Approval
08/16/2019 FOSAMAX
NDA #020560
SUPPL-70 ALENDRONATE SODIUM MERCK AND CO INC Labeling Approval
08/16/2019 SOMAVERT
NDA #021106
SUPPL-55 PEGVISOMANT PHARMACIA AND UPJOHN Labeling Approval
08/16/2019 FOSAMAX PLUS D
NDA #021762
SUPPL-22 ALENDRONATE SODIUM; CHOLECALCIFEROL MERCK 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 WEST-WARD PHARMS INT 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 EXTAVIA
BLA #125290
SUPPL-67 INTERFERON BETA-1B NOVARTIS 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 PEMETREXED SODIUM
ANDA #202596
ORIG-1 PEMETREXED SODIUM DR REDDYS LABS LTD Tentative 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 NANJING KING-FRIEND 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 HYDROCHLORIDE IMPACT BIOMEDICINES INC 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 SUNOVION PHARMS INC 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 WEST-WARD PHARMS INT 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 AKORN INC Labeling Approval
08/19/2019 ACETYLCYSTEINE
ANDA #203173
SUPPL-2 ACETYLCYSTEINE AKORN INC 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 PHARM LABS Labeling Approval
08/19/2019 OXYBUTYNIN CHLORIDE
ANDA #206121
SUPPL-3 OXYBUTYNIN CHLORIDE UNIQUE PHARM LABS 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 TOLMAR 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 ZYDUS PHARMS Approval
08/19/2019 TRIAMTERENE
ANDA #211581
ORIG-1 TRIAMTERENE AGNITIO Approval
08/19/2019 XENLETA
NDA #211672
ORIG-1 LEFAMULIN ACETATE NABRIVA THERAPEUTICS US INC Type 1 - New Molecular Entity Approval
08/19/2019 XENLETA
NDA #211673
ORIG-1 LEFAMULIN ACETATE NABRIVA THERAPEUTICS US INC 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 LANNETT CO INC Labeling Approval
08/20/2019 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243
SUPPL-23 CLINDAMYCIN HYDROCHLORIDE LANNETT CO INC Labeling Approval
08/20/2019 CLOPIDOGREL BISULFATE
ANDA #076273
SUPPL-18 CLOPIDOGREL BISULFATE DR REDDYS LABS INC 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 LABS LTD 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 THERAPS LLC 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 MYLAN Approval
08/21/2019 ACETYLCYSTEINE
ANDA #203624
SUPPL-2 ACETYLCYSTEINE MYLAN INSTITUTIONAL Labeling Approval
08/21/2019 ACETYLCYSTEINE
ANDA #203624
SUPPL-3 ACETYLCYSTEINE MYLAN INSTITUTIONAL 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 LTD Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #207698
SUPPL-4 NEVIRAPINE AUROBINDO PHARMA LTD Labeling Approval
08/21/2019 TICAGRELOR
ANDA #208531
SUPPL-1 TICAGRELOR AMNEAL PHARMS CO Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #208616
SUPPL-2 NEVIRAPINE AUROBINDO PHARMA LTD Labeling Approval
08/21/2019 NEVIRAPINE
ANDA #208616
SUPPL-4 NEVIRAPINE AUROBINDO PHARMA LTD Labeling Approval
08/21/2019 NORVIR
NDA #209512
SUPPL-5 RITONAVIR ABBVIE INC Labeling Approval
08/21/2019 GALLIUM DOTATOC GA 68
NDA #210828
ORIG-1 GALLIUM DOTATOC GA-68 UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER 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
NDA #018780
SUPPL-172 INSULIN HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN R
NDA #018780
SUPPL-172 INSULIN RECOMBINANT HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN R KWIKPEN
NDA #018780
SUPPL-172 INSULIN HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN R PEN
NDA #018780
SUPPL-172 INSULIN RECOMBINANT HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN N
NDA #018781
SUPPL-184 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN 70/30
NDA #019717
SUPPL-165 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Labeling Approval
08/22/2019 HUMULIN 70/30 PEN
NDA #019717
SUPPL-165 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Labeling 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 INC 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 Approval
08/22/2019 METHADONE HYDROCHLORIDE
ANDA #207368
ORIG-1 METHADONE HYDROCHLORIDE PHARM ASSOC 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 THERAPS US Labeling Approval
08/22/2019 LEVOLEUCOVORIN CALCIUM
ANDA #211003
ORIG-1 LEVOLEUCOVORIN CALCIUM NANJING KING-FRIEND Approval
08/22/2019 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #211830
ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM APOTEX INC Approval
08/22/2019 DAPTOMYCIN
ANDA #212022
ORIG-1 DAPTOMYCIN JIANGSU HENGRUI MED 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 LTD 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 HI TECH 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 PHARMS LLC Approval
08/26/2019 SEROQUEL
NDA #020639
SUPPL-66 QUETIAPINE FUMARATE ASTRAZENECA PHARMS 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 MYLAN Labeling Approval
08/26/2019 TEMAZEPAM
ANDA #070920
SUPPL-32 TEMAZEPAM MYLAN 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
08/27/2019 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 LTD Labeling Approval
08/27/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #077558
SUPPL-18 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD 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 Labeling Approval
08/27/2019 OCTREOTIDE ACETATE
ANDA #091041
SUPPL-5 OCTREOTIDE ACETATE SAGENT PHARMS 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 INC 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 LABS LTD Approval
08/28/2019 METFORMIN HYDROCHLORIDE
ANDA #075965
SUPPL-17 METFORMIN HYDROCHLORIDE SANDOZ Labeling Approval
08/28/2019 METFORMIN HYDROCHLORIDE
ANDA #075965
SUPPL-18 METFORMIN HYDROCHLORIDE SANDOZ Labeling Approval
08/28/2019 PEMETREXED
ANDA #203628
ORIG-1 PEMETREXED MYLAN LABS LTD Tentative 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 INC Labeling Approval
08/28/2019 ORILISSA
NDA #210450
SUPPL-2 ELAGOLIX SODIUM ABBVIE INC Labeling 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 PHARMACIA AND UPJOHN 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 AUROBINDO PHARMA LTD Labeling Approval
08/29/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065498
SUPPL-14 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695
SUPPL-10 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695
SUPPL-11 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
08/29/2019 LAMIVUDINE
ANDA #077695
SUPPL-12 LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
08/29/2019 NEVIRAPINE
ANDA #203411
SUPPL-4 NEVIRAPINE SANDOZ INC Labeling Approval
08/29/2019 NEVIRAPINE
ANDA #203411
SUPPL-5 NEVIRAPINE SANDOZ INC 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 RIOMET ER
NDA #212595
ORIG-1 METFORMIN HYDROCHLORIDE SUN PHARM INDS LTD 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 MYLAN LABS LTD Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #065458
SUPPL-6 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM MYLAN LABS LTD Labeling 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 INC Labeling Approval
08/30/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #203557
SUPPL-17 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ INC 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 AUROBINDO PHARMA LTD Labeling Approval
08/30/2019 MEROPENEM
ANDA #205835
SUPPL-3 MEROPENEM AUROBINDO PHARMA LTD Labeling Approval
08/30/2019 XELJANZ XR
NDA #208246
SUPPL-11 TOFACITINIB CITRATE PFIZER INC Labeling Approval
08/30/2019 ERTAPENEM SODIUM
ANDA #209133
SUPPL-1 ERTAPENEM SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/31/2019 GLYCOPYRROLATE
ANDA #090963
SUPPL-12 GLYCOPYRROLATE HIKMA FARMACEUTICA Labeling 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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