Drugs@FDA: FDA Approved Drug Products

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All Approvals
July 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 October 14, 2019.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/01/2019 TRUVADA
NDA #021752
SUPPL-60 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD REMS Approval
07/01/2019 JANUVIA
NDA #021995
SUPPL-46 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
07/01/2019 JANUMET
NDA #022044
SUPPL-47 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
07/01/2019 NESINA
NDA #022271
SUPPL-12 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Labeling Approval
07/01/2019 ONGLYZA
NDA #022350
SUPPL-23 SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
07/01/2019 OSENI
NDA #022426
SUPPL-12 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
07/01/2019 LANSOPRAZOLE
ANDA #077255
SUPPL-15 LANSOPRAZOLE TEVA PHARMS Labeling Approval
07/01/2019 LANSOPRAZOLE
ANDA #077255
SUPPL-16 LANSOPRAZOLE TEVA PHARMS Labeling Approval
07/01/2019 LANSOPRAZOLE
ANDA #077255
SUPPL-17 LANSOPRAZOLE TEVA PHARMS Labeling Approval
07/01/2019 LANSOPRAZOLE
ANDA #077255
SUPPL-18 LANSOPRAZOLE TEVA PHARMS Labeling Approval
07/01/2019 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513
SUPPL-13 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD REMS Approval
07/01/2019 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894
SUPPL-4 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA REMS Approval
07/01/2019 KOMBIGLYZE XR
NDA #200678
SUPPL-24 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
07/01/2019 TRADJENTA
NDA #201280
SUPPL-21 LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
07/01/2019 JENTADUETO
NDA #201281
SUPPL-25 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
07/01/2019 JANUMET XR
NDA #202270
SUPPL-20 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
07/01/2019 KAZANO
NDA #203414
SUPPL-12 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
07/01/2019 FEBUXOSTAT
ANDA #205385
ORIG-1 FEBUXOSTAT MYLAN Approval
07/01/2019 FEBUXOSTAT
ANDA #205421
ORIG-1 FEBUXOSTAT ALEMBIC PHARMS LTD Approval
07/01/2019 FEBUXOSTAT
ANDA #205467
ORIG-1 FEBUXOSTAT SUN PHARM Approval
07/01/2019 GLYXAMBI
NDA #206073
SUPPL-22 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
07/01/2019 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436
SUPPL-3 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN REMS Approval
07/01/2019 CHLORTHALIDONE
ANDA #207204
ORIG-1 CHLORTHALIDONE AMNEAL PHARMS CO Approval
07/01/2019 JENTADUETO XR
NDA #208026
SUPPL-13 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
07/01/2019 LYNPARZA
NDA #208558
SUPPL-9 OLAPARIB ASTRAZENECA PHARMS Efficacy Approval
07/01/2019 QTERN
NDA #209091
SUPPL-4 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
07/01/2019 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #209721
SUPPL-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AMNEAL PHARMS CO REMS Approval
07/01/2019 STEGLUJAN
NDA #209805
SUPPL-5 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
07/01/2019 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
ANDA #210183
ORIG-1 KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE LUPIN LTD Approval
07/01/2019 HALOPERIDOL
ANDA #210356
ORIG-1 HALOPERIDOL LACTATE FRESENIUS KABI USA Approval
07/01/2019 QTERNMET XR
NDA #210874
SUPPL-1 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
07/02/2019 ALEVE
NDA #020204
SUPPL-66 NAPROXEN SODIUM BAYER Labeling Approval
07/02/2019 ANGIOMAX
NDA #020873
SUPPL-39 BIVALIRUDIN SANDOZ INC Labeling Approval
07/02/2019 ITRACONAZOLE
ANDA #206410
ORIG-1 ITRACONAZOLE ANDA REPOSITORY Approval
07/02/2019 TRAMADOL HYDROCHLORIDE
ANDA #206706
ORIG-1 TRAMADOL HYDROCHLORIDE POLYGEN PHARMS Approval
07/02/2019 MISOPROSTOL
ANDA #210201
ORIG-1 MISOPROSTOL ZYDUS PHARMS Approval
07/02/2019 ERYTHROMYCIN
ANDA #210954
ORIG-1 ERYTHROMYCIN AMNEAL PHARMS CO Approval
07/02/2019 METRONIDAZOLE
ANDA #211786
ORIG-1 METRONIDAZOLE PERRIGO UK FINCO Approval
07/02/2019 CARBOPROST TROMETHAMINE
ANDA #211941
ORIG-1 CARBOPROST TROMETHAMINE DR REDDYS LABS LTD Approval
07/03/2019 ADDERALL XR 10
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 ADDERALL XR 15
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 ADDERALL XR 20
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 ADDERALL XR 25
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 ADDERALL XR 30
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 ADDERALL XR 5
NDA #021303
SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/03/2019 TRADJENTA
NDA #201280
SUPPL-18 LINAGLIPTIN BOEHRINGER INGELHEIM Efficacy Approval
07/03/2019 JENTADUETO
NDA #201281
SUPPL-22 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
07/03/2019 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #205588
SUPPL-6 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN LTD Manufacturing (CMC) Approval
07/03/2019 GLYXAMBI
NDA #206073
SUPPL-17 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Efficacy Approval
07/03/2019 JENTADUETO XR
NDA #208026
SUPPL-8 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
07/03/2019 APIXABAN
ANDA #210128
ORIG-1 APIXABAN MYLAN PHARMS INC Tentative Approval
07/03/2019 TRIENTINE HYDROCHLORIDE
ANDA #211076
ORIG-1 TRIENTINE HYDROCHLORIDE DR REDDYS LABS LTD Approval
07/03/2019 ADHANSIA XR
NDA #212038
SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE PURDUE PHARMA LP Labeling Approval
07/03/2019 XPOVIO
NDA #212306
ORIG-1 SELINEXOR KARYOPHARM THERAPS Type 1 - New Molecular Entity Approval
07/05/2019 EGRIFTA
NDA #022505
SUPPL-12 TESAMORELIN ACETATE THERATECHNOLOGIES Labeling Approval
07/05/2019 EGRIFTA
NDA #022505
SUPPL-13 TESAMORELIN ACETATE THERATECHNOLOGIES Labeling Approval
07/05/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091617
SUPPL-18 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
07/05/2019 LOSARTAN POTASSIUM
ANDA #201170
SUPPL-10 LOSARTAN POTASSIUM CADISTA PHARMS Labeling Approval
07/05/2019 AZITHROMYCIN
ANDA #210000
SUPPL-3 AZITHROMYCIN BIONPHARMA INC Labeling Approval
07/05/2019 AZITHROMYCIN
ANDA #210001
SUPPL-3 AZITHROMYCIN BIONPHARMA INC Labeling Approval
07/05/2019 FENOFIBRIC ACID
ANDA #210469
ORIG-1 CHOLINE FENOFIBRATE TWI PHARMS Approval
07/05/2019 RANOLAZINE
ANDA #211082
ORIG-1 RANOLAZINE GLENMARK PHARMS LTD Approval
07/05/2019 FLUOXETINE HYDROCHLORIDE
ANDA #212191
ORIG-1 FLUOXETINE HYDROCHLORIDE G AND W LABS INC Approval
07/08/2019 FAMCICLOVIR
ANDA #077487
SUPPL-9 FAMCICLOVIR TEVA PHARMS Labeling Approval
07/08/2019 FLUCONAZOLE
ANDA #077731
SUPPL-14 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
07/08/2019 FLUCONAZOLE
ANDA #077731
SUPPL-15 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
07/08/2019 FLUCONAZOLE
ANDA #077731
SUPPL-16 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
07/08/2019 FLUCONAZOLE
ANDA #077731
SUPPL-19 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
07/08/2019 FAMCICLOVIR
ANDA #078278
SUPPL-8 FAMCICLOVIR CIPLA Labeling Approval
07/08/2019 FAMCICLOVIR
ANDA #078278
SUPPL-10 FAMCICLOVIR CIPLA Labeling Approval
07/08/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385
SUPPL-17 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
07/08/2019 ADAPALENE
ANDA #090962
SUPPL-5 ADAPALENE P AND L Manufacturing (CMC) Approval
07/08/2019 FAMCICLOVIR
ANDA #091114
SUPPL-8 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
07/08/2019 FAMCICLOVIR
ANDA #091114
SUPPL-9 FAMCICLOVIR AUROBINDO PHARMA LTD Labeling Approval
07/08/2019 LYMPHOSEEK KIT
NDA #202207
SUPPL-9 TECHNETIUM TC-99M TILMANOCEPT CARDINAL HEALTH 414 Labeling Approval
07/08/2019 VORICONAZOLE
ANDA #206181
SUPPL-1 VORICONAZOLE AJANTA PHARMA LTD Labeling Approval
07/08/2019 VORICONAZOLE
ANDA #206181
SUPPL-3 VORICONAZOLE AJANTA PHARMA LTD Labeling Approval
07/08/2019 KATERZIA
NDA #211340
ORIG-1 AMLODIPINE BENZOATE SILVERGATE PHARMS Type 5 - New Formulation or New Manufacturer Approval
07/08/2019 VENLAFAXINE HYDROCHLORIDE
ANDA #212277
ORIG-1 VENLAFAXINE HYDROCHLORIDE ANNORA PHARMA Approval
07/09/2019 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113
SUPPL-7 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
07/09/2019 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113
SUPPL-7 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
07/09/2019 ADVIL CONGESTION RELIEF
NDA #022565
SUPPL-5 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
07/09/2019 IMIPENEM AND CILASTATIN
ANDA #090577
SUPPL-10 CILASTATIN SODIUM; IMIPENEM ACS DOBFAR Labeling Approval
07/09/2019 IMIPENEM AND CILASTATIN
ANDA #090577
SUPPL-12 CILASTATIN SODIUM; IMIPENEM ACS DOBFAR Labeling Approval
07/09/2019 ADAPALENE
ANDA #091314
SUPPL-5 ADAPALENE GLENMARK GENERICS Labeling Approval
07/09/2019 REBIF
BLA #103780
SUPPL-5204 INTERFERON BETA-1A SERONO INC Approval
07/09/2019 VORICONAZOLE
ANDA #200265
SUPPL-10 VORICONAZOLE SANDOZ INC Labeling Approval
07/09/2019 DOCETAXEL
NDA #203551
SUPPL-7 DOCETAXEL ACTAVIS LLC Labeling Approval
07/09/2019 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203895
SUPPL-2 BUPIVACAINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
07/09/2019 RISEDRONATE SODIUM
ANDA #203925
ORIG-1 RISEDRONATE SODIUM SUN PHARM Approval
07/09/2019 TELMISARTAN
ANDA #205150
SUPPL-5 TELMISARTAN INVENTIA Labeling Approval
07/09/2019 TELMISARTAN
ANDA #205150
SUPPL-7 TELMISARTAN INVENTIA Labeling Approval
07/09/2019 VORICONAZOLE
ANDA #206747
SUPPL-1 VORICONAZOLE CADILA Labeling Approval
07/09/2019 VORICONAZOLE
ANDA #206747
SUPPL-2 VORICONAZOLE CADILA Labeling Approval
07/09/2019 VORICONAZOLE
ANDA #206747
SUPPL-3 VORICONAZOLE CADILA Labeling Approval
07/09/2019 VORICONAZOLE
ANDA #206747
SUPPL-4 VORICONAZOLE CADILA Labeling Approval
07/09/2019 SILDENAFIL CITRATE
ANDA #211092
ORIG-1 SILDENAFIL CITRATE AMNEAL PHARMS NY Tentative Approval
07/09/2019 ATROPINE (AUTOINJECTOR)
NDA #212319
SUPPL-2 ATROPINE RAFA LABS LTD Labeling Approval
07/10/2019 INTELENCE
NDA #022187
SUPPL-25 ETRAVIRINE JANSSEN R AND D Labeling Approval
07/10/2019 PLEGRIDY
BLA #125499
SUPPL-19 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
07/10/2019 TECFIDERA
NDA #204063
SUPPL-24 DIMETHYL FUMARATE BIOGEN IDEC INC Labeling Approval
07/10/2019 TRIFERIC
NDA #206317
SUPPL-12 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
07/10/2019 POTASSIUM CHLORIDE
NDA #208019
SUPPL-2 POTASSIUM CHLORIDE PHARMA RES SOFTWARE Labeling Approval
07/10/2019 SORAFENIB TOSYLATE
ANDA #209050
ORIG-1 SORAFENIB TOSYLATE YABAO PHARM Tentative Approval
07/10/2019 ABIRATERONE ACETATE
ANDA #210686
ORIG-1 ABIRATERONE ACETATE MSN LABS PVT LTD Approval
07/10/2019 CYCLOSPORINE
ANDA #210721
ORIG-1 CYCLOSPORINE APOTEX INC Approval
07/10/2019 CLOBAZAM
ANDA #210746
ORIG-1 CLOBAZAM VISTAPHARM Approval
07/10/2019 OMEGA-3-ACID ETHYL ESTERS
ANDA #211355
ORIG-1 OMEGA-3-ACID ETHYL ESTERS SOFGEN PHARMS Approval
07/10/2019 LARTRUVO
BLA #761038
SUPPL-1 OLARATUMAB ELI LILLY AND CO Approval
07/11/2019 ALBENZA
NDA #020666
SUPPL-12 ALBENDAZOLE IMPAX LABS INC Labeling Approval
07/12/2019 DILANTIN-125
NDA #008762
SUPPL-63 PHENYTOIN PARKE DAVIS Labeling Approval
07/12/2019 DILANTIN-30
NDA #008762
SUPPL-63 PHENYTOIN PARKE DAVIS Labeling Approval
07/12/2019 CEREBYX
NDA #020450
SUPPL-39 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
07/12/2019 BUPRENORPHINE HYDROCHLORIDE
ANDA #076931
SUPPL-11 BUPRENORPHINE HYDROCHLORIDE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
07/12/2019 AVONEX
BLA #103628
SUPPL-5264 INTERFERON BETA-1A BIOGEN Approval
07/12/2019 GADAVIST
NDA #201277
SUPPL-17 GADOBUTROL BAYER HLTHCARE Efficacy Approval
07/12/2019 TECHNETIUM TC99M MERTIATIDE KIT
ANDA #208994
ORIG-1 TECHNETIUM TC-99M MERTIATIDE KIT PHARMALUCENCE Approval
07/12/2019 ACYCLOVIR
ANDA #209000
SUPPL-1 ACYCLOVIR ALEMBIC PHARMS LTD Manufacturing (CMC) Approval
07/12/2019 ISOSULFAN BLUE
ANDA #210558
ORIG-1 ISOSULFAN BLUE SOMERSET THERAPS LLC Approval
07/12/2019 AEMCOLO
NDA #210910
SUPPL-1 RIFAMYCIN COSMO TECHNOLOGIES Labeling Approval
07/12/2019 ETHACRYNIC ACID
ANDA #211809
ORIG-1 ETHACRYNIC ACID AGNITIO Approval
07/12/2019 SILDENAFIL
ANDA #212440
ORIG-1 SILDENAFIL ALKEM LABS LTD Tentative Approval
07/12/2019 IVERMECTIN
ANDA #212485
ORIG-1 IVERMECTIN TEVA PHARMS USA Tentative Approval
07/12/2019 DAPTOMYCIN
ANDA #212667
ORIG-1 DAPTOMYCIN ACCORD HLTHCARE Approval
07/12/2019 JEUVEAU
BLA #761085
SUPPL-1 PRABOTULINUMTOXINA-XVFS EVOLUS INC Approval
07/14/2019 HELIUM, USP
NDA #213609
ORIG-1 HELIUM ROBERTS OXYGEN CO INC Medical Gas Approval
07/15/2019 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
NDA #017634
SUPPL-76 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
07/15/2019 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
NDA #017634
SUPPL-76 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
07/15/2019 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
NDA #017634
SUPPL-76 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
07/15/2019 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017634
SUPPL-76 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
07/15/2019 HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609
SUPPL-54 HEPARIN SODIUM BAXTER HLTHCARE Labeling Approval
07/15/2019 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609
SUPPL-54 HEPARIN SODIUM BAXTER HLTHCARE Labeling Approval
07/15/2019 HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609
SUPPL-54 HEPARIN SODIUM BAXTER HLTHCARE Labeling Approval
07/15/2019 RAPAMUNE
NDA #021083
SUPPL-64 SIROLIMUS PF PRISM CV Labeling Approval
07/15/2019 RAPAMUNE
NDA #021110
SUPPL-83 SIROLIMUS PF PRISM CV Labeling Approval
07/15/2019 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204659
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE PAR PHARM Approval
07/15/2019 IMBRUVICA
NDA #205552
SUPPL-28 IBRUTINIB PHARMACYCLICS INC Labeling Approval
07/15/2019 AUSTEDO
NDA #208082
SUPPL-4 DEUTETRABENAZINE TEVA BRANDED PHARM Labeling Approval
07/15/2019 INGREZZA
NDA #209241
SUPPL-12 VALBENAZINE TOSYLATE NEUROCRINE Labeling Approval
07/15/2019 ICATIBANT ACETATE
ANDA #210118
ORIG-1 ICATIBANT ACETATE TEVA PHARMS USA Approval
07/15/2019 IMBRUVICA
NDA #210563
SUPPL-3 IBRUTINIB PHARMACYCLICS INC Labeling Approval
07/16/2019 PENTASA
NDA #020049
SUPPL-32 MESALAMINE SHIRE Labeling Approval
07/16/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070184
SUPPL-69 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
07/16/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #071250
SUPPL-37 METOCLOPRAMIDE HYDROCHLORIDE IMPAX LABS INC Labeling Approval
07/16/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #072801
SUPPL-44 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076077
SUPPL-13 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076077
SUPPL-14 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076077
SUPPL-15 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076077
SUPPL-16 FLUCONAZOLE IVAX SUB TEVA PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076658
SUPPL-14 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076658
SUPPL-15 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076658
SUPPL-16 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #076658
SUPPL-17 FLUCONAZOLE DR REDDYS LABS INC Labeling Approval
07/16/2019 RIVASTIGMINE TARTRATE
ANDA #077130
SUPPL-5 RIVASTIGMINE TARTRATE DR REDDYS LABS INC Labeling Approval
07/16/2019 RIVASTIGMINE TARTRATE
ANDA #077130
SUPPL-6 RIVASTIGMINE TARTRATE DR REDDYS LABS INC Labeling Approval
07/16/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #077878
SUPPL-12 METOCLOPRAMIDE HYDROCHLORIDE VINTAGE PHARMS Labeling Approval
07/16/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #079128
SUPPL-13 LAMIVUDINE; ZIDOVUDINE STRIDES PHARMA Labeling Approval
07/16/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #079128
SUPPL-14 LAMIVUDINE; ZIDOVUDINE STRIDES PHARMA Labeling Approval
07/16/2019 METHADONE HYDROCHLORIDE
ANDA #090635
SUPPL-19 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC Labeling Approval
07/16/2019 METHADONE HYDROCHLORIDE
ANDA #090635
SUPPL-21 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC Labeling Approval
07/16/2019 METHADONE HYDROCHLORIDE
ANDA #090635
SUPPL-22 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC Labeling Approval
07/16/2019 MUPIROCIN
ANDA #201587
SUPPL-9 MUPIROCIN CALCIUM GLENMARK PHARMS INC Labeling Approval
07/16/2019 TAFINLAR
NDA #202806
SUPPL-13 DABRAFENIB MESYLATE NOVARTIS Labeling Approval
07/16/2019 TEMOZOLOMIDE
ANDA #203691
SUPPL-4 TEMOZOLOMIDE AMNEAL PHARMS Labeling Approval
07/16/2019 MEKINIST
NDA #204114
SUPPL-13 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Labeling Approval
07/16/2019 LINEZOLID
ANDA #204764
SUPPL-3 LINEZOLID FRESENIUS KABI USA Labeling Approval
07/16/2019 DACTINOMYCIN
ANDA #207232
ORIG-1 DACTINOMYCIN HISUN PHARM HANGZHOU Approval
07/16/2019 EVEROLIMUS
ANDA #207486
ORIG-1 EVEROLIMUS WEST-WARD PHARMS INT Tentative Approval
07/16/2019 FLUCONAZOLE
ANDA #208963
SUPPL-1 FLUCONAZOLE ZYDUS PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #208963
SUPPL-2 FLUCONAZOLE ZYDUS PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #208963
SUPPL-3 FLUCONAZOLE ZYDUS PHARMS Labeling Approval
07/16/2019 FLUCONAZOLE
ANDA #208963
SUPPL-5 FLUCONAZOLE ZYDUS PHARMS Labeling Approval
07/16/2019 ENZALUTAMIDE
ANDA #211465
ORIG-1 ENZALUTAMIDE EUGIA PHARMA Tentative Approval
07/16/2019 GEFITINIB
ANDA #211826
ORIG-1 GEFITINIB CIPLA LTD Tentative Approval
07/16/2019 RECARBRIO
NDA #212819
ORIG-1 CILASTATIN SODIUM; IMIPENEM; RELEBACTAM MSD MERCK CO Type 1 - New Molecular Entity and Type 4 - New Combination Approval
07/16/2019 DARZALEX
BLA #761036
SUPPL-19 DARATUMUMAB JANSSEN BIOTECH Approval
07/16/2019 OCREVUS
BLA #761053
SUPPL-18 OCRELIZUMAB GENENTECH INC Approval
07/17/2019 LAMISIL
NDA #020980
SUPPL-12 TERBINAFINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
07/17/2019 RIVASTIGMINE TARTRATE
ANDA #091072
SUPPL-7 RIVASTIGMINE TARTRATE APOTEX INC Labeling Approval
07/17/2019 RIVASTIGMINE TARTRATE
ANDA #091072
SUPPL-8 RIVASTIGMINE TARTRATE APOTEX INC Labeling Approval
07/17/2019 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #210080
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE NESHER PHARMS Approval
07/17/2019 DAPAGLIFLOZIN
ANDA #211312
ORIG-1 DAPAGLIFLOZIN SANDOZ INC Tentative Approval
07/17/2019 TRANEXAMIC ACID
ANDA #212360
ORIG-1 TRANEXAMIC ACID CAPLIN Approval
07/17/2019 TRANEXAMIC ACID
ANDA #212676
ORIG-1 TRANEXAMIC ACID APOLLO PHARMS INC Approval
07/18/2019 PROSTIN VR PEDIATRIC
NDA #018484
SUPPL-28 ALPROSTADIL PHARMACIA AND UPJOHN Labeling Approval
07/18/2019 MEGACE
NDA #020264
SUPPL-21 MEGESTROL ACETATE BRISTOL MYERS SQUIBB Labeling Approval
07/18/2019 MEPRON
NDA #020500
SUPPL-19 ATOVAQUONE GLAXOSMITHKLINE LLC Labeling Approval
07/18/2019 LAMISIL AT
NDA #021124
SUPPL-15 TERBINAFINE HYDROCHLORIDE GLAXOSMITHKLINE CONS Manufacturing (CMC) Approval
07/18/2019 LIALDA
NDA #022000
SUPPL-18 MESALAMINE SHIRE Labeling Approval
07/18/2019 OLMESARTAN MEDOXOMIL
ANDA #207135
ORIG-1 OLMESARTAN MEDOXOMIL UMEDICA LABS PVT LTD Approval
07/18/2019 BEVYXXA
NDA #208383
SUPPL-6 BETRIXABAN PORTOLA PHARMS INC Labeling Approval
07/18/2019 ZINC SULFATE
NDA #209377
ORIG-1 ZINC SULFATE AM REGENT Type 5 - New Formulation or New Manufacturer Approval
07/18/2019 FENOFIBRIC ACID
ANDA #211626
ORIG-1 CHOLINE FENOFIBRATE GRAVITI PHARMS Approval
07/19/2019 COPAXONE
NDA #020622
SUPPL-106 GLATIRAMER ACETATE TEVA PHARMS USA Labeling Approval
07/19/2019 ZYBAN
NDA #020711
SUPPL-48 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
07/19/2019 PREGABALIN
ANDA #091219
ORIG-1 PREGABALIN TEVA PHARMS Approval
07/19/2019 PREGABALIN
ANDA #091224
ORIG-1 PREGABALIN TEVA PHARMS Approval
07/19/2019 CLOPIDOGREL BISULFATE
ANDA #202925
SUPPL-7 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
07/19/2019 CLOPIDOGREL BISULFATE
ANDA #202925
SUPPL-8 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
07/19/2019 CLOPIDOGREL BISULFATE
ANDA #202925
SUPPL-9 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
07/19/2019 CLOPIDOGREL BISULFATE
ANDA #202925
SUPPL-10 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
07/19/2019 PREGABALIN
ANDA #203459
ORIG-1 PREGABALIN ALEMBIC PHARMS LTD Approval
07/19/2019 OTEZLA
NDA #205437
SUPPL-7 APREMILAST CELGENE CORP Efficacy Approval
07/19/2019 PREGABALIN
ANDA #207623
ORIG-1 PREGABALIN ALKEM LABS LTD Approval
07/19/2019 PREGABALIN
ANDA #207799
ORIG-1 PREGABALIN ALKEM LABS LTD Approval
07/19/2019 PREGABALIN
ANDA #208677
ORIG-1 PREGABALIN SCIEGEN PHARMS INC Approval
07/19/2019 PREGABALIN
ANDA #209357
ORIG-1 PREGABALIN MSN LABS PVT LTD Approval
07/19/2019 PREGABALIN
ANDA #209664
ORIG-1 PREGABALIN DR REDDYS Approval
07/19/2019 PREGABALIN
ANDA #209743
ORIG-1 PREGABALIN AMNEAL PHARMS CO Approval
07/19/2019 ERLOTINIB
ANDA #210300
ORIG-1 ERLOTINIB SUN PHARM INDUSTRIES Tentative Approval
07/19/2019 PREGABALIN
ANDA #210432
ORIG-1 PREGABALIN RISING Approval
07/19/2019 CLOBAZAM
ANDA #211259
SUPPL-1 CLOBAZAM MYLAN Manufacturing (CMC) Approval
07/19/2019 PREGABALIN
ANDA #211384
ORIG-1 PREGABALIN INVAGEN PHARMS Approval
07/19/2019 DAPAGLIFLOZIN
ANDA #211560
ORIG-1 DAPAGLIFLOZIN ALEMBIC PHARMS LTD Tentative Approval
07/19/2019 APREMILAST
ANDA #211782
ORIG-1 APREMILAST AMNEAL PHARMS CO Tentative Approval
07/19/2019 DRIZALMA SPRINKLE
NDA #212516
ORIG-1 DULOXETINE HYDROCHLORIDE SUN PHARMA GLOBAL Type 5 - New Formulation or New Manufacturer Approval
07/19/2019 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #212631
ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
07/19/2019 IMFINZI
BLA #761069
SUPPL-13 DURVALUMAB ASTRAZENECA UK LTD Approval
07/21/2019 MEROPENEM
ANDA #091404
SUPPL-15 MEROPENEM ACS DOBFAR Labeling Approval
07/21/2019 MEROPENEM
ANDA #091404
SUPPL-16 MEROPENEM ACS DOBFAR Labeling Approval
07/21/2019 MEROPENEM
ANDA #091404
SUPPL-18 MEROPENEM ACS DOBFAR Labeling Approval
07/21/2019 MEROPENEM
ANDA #091404
SUPPL-19 MEROPENEM ACS DOBFAR Labeling Approval
07/21/2019 MEROPENEM
ANDA #091404
SUPPL-20 MEROPENEM ACS DOBFAR Labeling Approval
07/21/2019 MEROPENEM
ANDA #205883
SUPPL-1 MEROPENEM AMNEAL PHARMS Labeling Approval
07/21/2019 MEROPENEM
ANDA #205883
SUPPL-3 MEROPENEM AMNEAL PHARMS Labeling Approval
07/21/2019 MEROPENEM
ANDA #205883
SUPPL-4 MEROPENEM AMNEAL PHARMS Labeling Approval
07/21/2019 MEROPENEM
ANDA #205883
SUPPL-5 MEROPENEM AMNEAL PHARMS Labeling Approval
07/21/2019 MEROPENEM
ANDA #205883
SUPPL-6 MEROPENEM AMNEAL PHARMS Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141
SUPPL-1 MEROPENEM GLAND PHARMA LTD Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141
SUPPL-2 MEROPENEM GLAND PHARMA LTD Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141
SUPPL-3 MEROPENEM GLAND PHARMA LTD Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141
SUPPL-4 MEROPENEM GLAND PHARMA LTD Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141
SUPPL-5 MEROPENEM GLAND PHARMA LTD Labeling Approval
07/22/2019 DROXIA
NDA #016295
SUPPL-51 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
07/22/2019 HYDREA
NDA #016295
SUPPL-51 HYDROXYUREA BRISTOL MYERS SQUIBB Labeling Approval
07/22/2019 NAPROSYN
NDA #017581
SUPPL-114 NAPROXEN ATNAHS PHARMA US Labeling Approval
07/22/2019 ANAPROX
NDA #018164
SUPPL-64 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
07/22/2019 ANAPROX DS
NDA #018164
SUPPL-64 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
07/22/2019 NAPROSYN
NDA #018965
SUPPL-26 NAPROXEN ATNAHS PHARMA US Labeling Approval
07/22/2019 EC-NAPROSYN
NDA #020067
SUPPL-21 NAPROXEN ATNAHS PHARMA US Labeling Approval
07/22/2019 NAPRELAN
NDA #020353
SUPPL-36 NAPROXEN SODIUM ALVOGEN Labeling Approval
07/22/2019 SEREVENT
NDA #020692
SUPPL-47 SALMETEROL XINAFOATE GLAXOSMITHKLINE Labeling Approval
07/22/2019 TREXIMET
NDA #021926
SUPPL-16 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
07/22/2019 CALDOLOR
NDA #022348
SUPPL-14 IBUPROFEN CUMBERLAND PHARMS Labeling Approval
07/22/2019 VIMOVO
NDA #022511
SUPPL-24 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
07/22/2019 DUEXIS
NDA #022519
SUPPL-12 FAMOTIDINE; IBUPROFEN HORIZON Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070045
SUPPL-28 IBUPROFEN MYLAN Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070057
SUPPL-28 IBUPROFEN MYLAN Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070079
SUPPL-37 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070080
SUPPL-39 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070329
SUPPL-39 IBUPROFEN PAR PHARM Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070330
SUPPL-39 IBUPROFEN PAR PHARM Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070986
SUPPL-34 IBUPROFEN PAR PHARM Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071230
SUPPL-16 IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071231
SUPPL-18 IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071232
SUPPL-18 IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071268
SUPPL-14 IBUPROFEN CONTRACT PHARMACAL Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071334
SUPPL-40 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071335
SUPPL-41 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071448
SUPPL-18 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071644
SUPPL-11 IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071935
SUPPL-33 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 IBUPROFEN
ANDA #071999
SUPPL-20 IBUPROFEN MYLAN Labeling Approval
07/22/2019 IBUPROFEN
ANDA #072004
SUPPL-16 IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 IBUPROFEN
ANDA #072169
SUPPL-11 IBUPROFEN SANDOZ Labeling Approval
07/22/2019 IBUPROFEN
ANDA #074978
SUPPL-48 IBUPROFEN ACTAVIS MID ATLANTIC Labeling Approval
07/22/2019 IBUPROFEN
ANDA #075682
SUPPL-16 IBUPROFEN DR REDDYS LA Labeling Approval
07/22/2019 IBUPROFEN
ANDA #076112
SUPPL-16 IBUPROFEN DR REDDYS LABS INC Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642
SUPPL-27 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 REPREXAIN
ANDA #076642
SUPPL-27 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 IBUPROFEN
ANDA #076925
SUPPL-41 IBUPROFEN L PERRIGO CO Labeling Approval
07/22/2019 IBUPROFEN
ANDA #077114
SUPPL-13 IBUPROFEN PERRIGO PHARMS CO Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454
SUPPL-4 HYDROCODONE BITARTRATE; IBUPROFEN ANI PHARMS INC Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723
SUPPL-26 HYDROCODONE BITARTRATE; IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077727
SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN VINTAGE PHARMS Labeling Approval
07/22/2019 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078316
SUPPL-10 IBUPROFEN; OXYCODONE HYDROCHLORIDE BARR LABS INC Labeling Approval
07/22/2019 IBUPROFEN
ANDA #078329
SUPPL-11 IBUPROFEN STRIDES PHARMA Labeling Approval
07/22/2019 IBUPROFEN
ANDA #078558
SUPPL-27 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
07/22/2019 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078769
SUPPL-24 IBUPROFEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
07/22/2019 IBUPROFEN
ANDA #090796
SUPPL-2 IBUPROFEN MARKSANS PHARMA Labeling Approval
07/22/2019 IBUPROFEN
ANDA #091625
SUPPL-8 IBUPROFEN GRANULES INDIA LTD Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #091633
SUPPL-10 HYDROCODONE BITARTRATE; IBUPROFEN SUN PHARM INDS INC Labeling Approval
07/22/2019 RIVASTIGMINE TARTRATE
ANDA #091689
SUPPL-7 RIVASTIGMINE TARTRATE ALEMBIC PHARMS LTD Labeling Approval
07/22/2019 RIVASTIGMINE TARTRATE
ANDA #091689
SUPPL-11 RIVASTIGMINE TARTRATE ALEMBIC PHARMS LTD Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052
SUPPL-2 PANTOPRAZOLE SODIUM ORCHID HLTHCARE Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052
SUPPL-3 PANTOPRAZOLE SODIUM ORCHID HLTHCARE Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052
SUPPL-5 PANTOPRAZOLE SODIUM ORCHID HLTHCARE Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052
SUPPL-6 PANTOPRAZOLE SODIUM ORCHID HLTHCARE Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052
SUPPL-7 PANTOPRAZOLE SODIUM ORCHID HLTHCARE Labeling Approval
07/22/2019 IBUPROFEN
ANDA #202413
SUPPL-9 IBUPROFEN SHANDONG XINHUA Labeling Approval
07/22/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #202418
SUPPL-4 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #202418
SUPPL-6 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #202418
SUPPL-7 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #202418
SUPPL-8 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #202418
SUPPL-10 LAMIVUDINE; ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 METFORMIN HYDROCHLORIDE
ANDA #202917
SUPPL-7 METFORMIN HYDROCHLORIDE SUN PHARM Manufacturing (CMC) Approval
07/22/2019 IBUPROFEN
ANDA #204062
SUPPL-2 IBUPROFEN HEC PHARM Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #204575
SUPPL-4 HYDROCODONE BITARTRATE; IBUPROFEN AUROLIFE PHARMA LLC Labeling Approval
07/22/2019 IBUPROFEN
ANDA #205647
SUPPL-1 IBUPROFEN HI TECH Labeling Approval
07/22/2019 ILOPERIDONE
ANDA #207098
ORIG-1 ILOPERIDONE TARO PHARM INDS LTD Approval
07/22/2019 AZACITIDINE
ANDA #207475
SUPPL-2 AZACITIDINE ACCORD HLTHCARE Labeling Approval
07/22/2019 IBUPROFEN
ANDA #209178
SUPPL-4 IBUPROFEN AUROBINDO PHARMA LTD Labeling Approval
07/22/2019 IBUPROFEN
ANDA #209204
SUPPL-4 IBUPROFEN TARO Labeling Approval
07/22/2019 MORPHINE SULFATE
ANDA #210610
ORIG-1 MORPHINE SULFATE UPSHER SMITH LABS Approval
07/22/2019 RAMELTEON
ANDA #211567
ORIG-1 RAMELTEON ZYDUS PHARMS Approval
07/23/2019 ALEVE
NDA #020204
SUPPL-67 NAPROXEN SODIUM BAYER Labeling Approval
07/23/2019 ORPHENADRINE CITRATE
ANDA #040463
SUPPL-10 ORPHENADRINE CITRATE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
07/23/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #090246
SUPPL-8 LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
07/23/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #090246
SUPPL-9 LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
07/23/2019 LAMIVUDINE AND ZIDOVUDINE
ANDA #090246
SUPPL-10 LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
07/23/2019 KYRA
ANDA #202318
ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL SUN PHARM Approval
07/23/2019 RIVASTIGMINE TARTRATE
ANDA #203148
SUPPL-4 RIVASTIGMINE TARTRATE MACLEODS PHARMS LTD Labeling Approval
07/23/2019 RIVASTIGMINE TARTRATE
ANDA #203148
SUPPL-11 RIVASTIGMINE TARTRATE MACLEODS PHARMS LTD Labeling Approval
07/23/2019 RIVASTIGMINE TARTRATE
ANDA #203844
SUPPL-2 RIVASTIGMINE TARTRATE CADILA PHARMS LTD Labeling Approval
07/23/2019 RIVASTIGMINE TARTRATE
ANDA #203844
SUPPL-3 RIVASTIGMINE TARTRATE CADILA PHARMS LTD Labeling Approval
07/23/2019 PARICALCITOL
ANDA #203897
SUPPL-4 PARICALCITOL MYLAN LABS LTD Labeling Approval
07/23/2019 TRINTELLIX
NDA #204447
SUPPL-18 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Labeling Approval
07/23/2019 DOTAREM
NDA #204781
SUPPL-12 GADOTERATE MEGLUMINE GUERBET Labeling Approval
07/23/2019 AZITHROMYCIN
ANDA #205666
SUPPL-1 AZITHROMYCIN AMNEAL PHARMS LLC Labeling Approval
07/23/2019 FULVESTRANT
ANDA #208811
ORIG-1 FULVESTRANT MYLAN INSTITUTIONAL Approval
07/23/2019 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #208990
SUPPL-1 ABACAVIR SULFATE; LAMIVUDINE ZYDUS PHARMS Labeling Approval
07/23/2019 HADLIMA
BLA #761059
ORIG-1 ADALIMUMAB-BWWD SAMSUNG BIOEPIS CO LTD Approval
07/23/2019 RUXIENCE
BLA #761103
ORIG-1 RITUXIMAB-PVVR PFIZER INC Approval
07/24/2019 EXJADE
NDA #021882
SUPPL-30 DEFERASIROX NOVARTIS Efficacy Approval
07/24/2019 METRONIDAZOLE
ANDA #079067
SUPPL-10 METRONIDAZOLE ALEMBIC PHARMS LTD Labeling Approval
07/24/2019 METRONIDAZOLE
ANDA #079067
SUPPL-11 METRONIDAZOLE ALEMBIC PHARMS LTD Labeling Approval
07/24/2019 AUBAGIO
NDA #202992
SUPPL-6 TERIFLUNOMIDE SANOFI AVENTIS US Efficacy Approval
07/24/2019 PARICALCITOL
ANDA #205982
SUPPL-2 PARICALCITOL AUROBINDO PHARMA LTD Labeling Approval
07/24/2019 AZEDRA
NDA #209607
SUPPL-1 IOBENGUANE I-131 PROGENICS PHARMS INC Manufacturing (CMC) Approval
07/24/2019 BAQSIMI
NDA #210134
ORIG-1 GLUCAGON ELI LILLY AND CO Type 3 - New Dosage Form Approval
07/24/2019 NYSTATIN
ANDA #212557
ORIG-1 NYSTATIN TORRENT Approval
07/25/2019 ETHYOL
NDA #020221
SUPPL-36 AMIFOSTINE CLINIGEN HLTHCARE Labeling Approval
07/25/2019 FERRIPROX
NDA #021825
SUPPL-4 DEFERIPRONE APOPHARMA INC Efficacy Approval
07/25/2019 TACLONEX
NDA #022185
SUPPL-27 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Efficacy Approval
07/25/2019 TACLONEX
NDA #022185
SUPPL-27 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Efficacy Approval
07/25/2019 DESMOPRESSIN ACETATE
ANDA #074888
SUPPL-26 DESMOPRESSIN ACETATE TEVA PHARMS USA Labeling Approval
07/25/2019 DESMOPRESSIN ACETATE
ANDA #074888
SUPPL-27 DESMOPRESSIN ACETATE TEVA PHARMS USA Labeling Approval
07/25/2019 SPIRONOLACTONE
ANDA #089424
SUPPL-58 SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #090128
SUPPL-4 FAMCICLOVIR WEST-WARD PHARMS INT Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #090128
SUPPL-5 FAMCICLOVIR WEST-WARD PHARMS INT Labeling Approval
07/25/2019 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #091144
SUPPL-13 ABACAVIR SULFATE; LAMIVUDINE CIPLA Labeling Approval
07/25/2019 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #091144
SUPPL-15 ABACAVIR SULFATE; LAMIVUDINE CIPLA Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #091480
SUPPL-5 FAMCICLOVIR APOTEX Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #091480
SUPPL-6 FAMCICLOVIR APOTEX Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #201022
SUPPL-14 FAMCICLOVIR MACLEODS PHARMS LTD Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #201022
SUPPL-22 FAMCICLOVIR MACLEODS PHARMS LTD Labeling Approval
07/25/2019 XELJANZ
NDA #203214
SUPPL-24 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
07/25/2019 CELECOXIB
ANDA #204197
SUPPL-6 CELECOXIB APOTEX INC Labeling Approval
07/25/2019 DESMOPRESSIN ACETATE
ANDA #204695
SUPPL-1 DESMOPRESSIN ACETATE SAGENT PHARMS INC Labeling Approval
07/25/2019 DESMOPRESSIN ACETATE
ANDA #204751
SUPPL-1 DESMOPRESSIN ACETATE SAGENT PHARMS INC Labeling Approval
07/25/2019 CELECOXIB
ANDA #206827
SUPPL-4 CELECOXIB AUROBINDO PHARMA LTD Labeling Approval
07/25/2019 AZITHROMYCIN
ANDA #207531
SUPPL-3 AZITHROMYCIN EPIC PHARMA LLC Labeling Approval
07/25/2019 JADENU SPRINKLE
NDA #207968
SUPPL-7 DEFERASIROX NOVARTIS Efficacy Approval
07/25/2019 XELJANZ XR
NDA #208246
SUPPL-10 TOFACITINIB CITRATE PFIZER INC Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573
SUPPL-11 VENETOCLAX ABBVIE INC Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573
SUPPL-14 VENETOCLAX ABBVIE INC Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573
SUPPL-15 VENETOCLAX ABBVIE INC Labeling Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-2 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-3 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-4 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-5 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-6 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-7 EXENATIDE ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210
SUPPL-8 EXENATIDE ASTRAZENECA AB Labeling Approval
07/25/2019 ANGIOMAX RTU
NDA #211215
ORIG-1 BIVALIRUDIN MAIA PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
07/25/2019 CLOTRIMAZOLE
ANDA #212281
ORIG-1 CLOTRIMAZOLE TASMAN PHARMA Approval
07/25/2019 ACCRUFER
NDA #212320
ORIG-1 FERRIC MALTOL SHIELD TX Type 1 - New Molecular Entity Approval
07/25/2019 FENOFIBRIC ACID
ANDA #212598
ORIG-1 CHOLINE FENOFIBRATE AUROBINDO PHARMA LTD Approval
07/26/2019 ELLENCE
NDA #050778
SUPPL-24 EPIRUBICIN HYDROCHLORIDE PFIZER INC Labeling Approval
07/26/2019 ELLENCE
NDA #050778
SUPPL-25 EPIRUBICIN HYDROCHLORIDE PFIZER INC Labeling Approval
07/26/2019 PROLIA
BLA #125320
SUPPL-198 DENOSUMAB AMGEN Approval
07/26/2019 XGEVA
BLA #125320
SUPPL-198 DENOSUMAB AMGEN Approval
07/26/2019 JADENU
NDA #206910
SUPPL-12 DEFERASIROX NOVARTIS PHARMS CORP Efficacy Approval
07/26/2019 NICOTINE POLACRILEX
ANDA #212056
ORIG-1 NICOTINE POLACRILEX P AND L Approval
07/26/2019 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #212114
ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE LAURUS LABS LTD Approval
07/29/2019 CEFTAZIDIME IN DEXTROSE CONTAINER
NDA #050823
SUPPL-7 CEFTAZIDIME B BRAUN Labeling Approval
07/29/2019 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
NDA #065214
SUPPL-16 CEFOXITIN SODIUM B BRAUN Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #070039
SUPPL-13 METRONIDAZOLE STRIDES PHARMA Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #070040
SUPPL-13 METRONIDAZOLE STRIDES PHARMA Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #070044
SUPPL-58 METRONIDAZOLE WATSON LABS INC Labeling Approval
07/29/2019 ALLOPURINOL
ANDA #070147
SUPPL-11 ALLOPURINOL PURACAP PHARM Labeling Approval
07/29/2019 ALLOPURINOL
ANDA #070150
SUPPL-10 ALLOPURINOL PURACAP PHARM Labeling Approval
07/29/2019 DESMOPRESSIN ACETATE
ANDA #075220
SUPPL-20 DESMOPRESSIN ACETATE HOSPIRA Labeling Approval
07/29/2019 RADIOGENIX SYSTEM
NDA #202158
SUPPL-9 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR NORTHSTAR MEDICAL Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #203974
SUPPL-5 METRONIDAZOLE AUROBINDO PHARMA LTD Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #205245
SUPPL-4 METRONIDAZOLE HERITAGE PHARMS INC Labeling Approval
07/29/2019 ARGATROBAN IN 0.9% SODIUM CHLORIDE
NDA #206769
SUPPL-4 ARGATROBAN TEVA PHARMS USA Labeling Approval
07/29/2019 METRONIDAZOLE
ANDA #209096
SUPPL-1 METRONIDAZOLE LUPIN LTD Labeling Approval
07/29/2019 TICAGRELOR
ANDA #209947
ORIG-1 TICAGRELOR BEIJING TIDE PHARMA CO LTD Tentative Approval
07/29/2019 CINACALCET
ANDA #211892
ORIG-1 CINACALCET ACCORD HLTHCARE INC Tentative Approval
07/29/2019 PIPERACILLIN AND TAZOBACTAM
ANDA #212287
ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ASTRAL Approval
07/30/2019 VPRIV
NDA #022575
SUPPL-22 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Labeling Approval
07/30/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070581
SUPPL-44 METOCLOPRAMIDE HYDROCHLORIDE PAR PHARM INC Labeling Approval
07/30/2019 IRBESARTAN
ANDA #090201
SUPPL-5 IRBESARTAN WEST-WARD PHARMS INT Labeling Approval
07/30/2019 ALLOPURINOL
ANDA #090637
SUPPL-4 ALLOPURINOL IPCA LABS LTD Labeling Approval
07/30/2019 KEYTRUDA
BLA #125514
SUPPL-55 PEMBROLIZUMAB MERCK SHARP DOHME Approval
07/30/2019 KEYTRUDA
BLA #125514
SUPPL-56 PEMBROLIZUMAB MERCK SHARP DOHME Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #201408
SUPPL-4 GUANFACINE HYDROCHLORIDE TWI PHARMS Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #201408
SUPPL-5 GUANFACINE HYDROCHLORIDE TWI PHARMS Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #201408
SUPPL-8 GUANFACINE HYDROCHLORIDE TWI PHARMS Labeling Approval
07/30/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #201467
ORIG-1 MINOCYCLINE HYDROCHLORIDE MYLAN LABS LTD Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #202568
SUPPL-2 GUANFACINE HYDROCHLORIDE SANDOZ INC Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #202568
SUPPL-3 GUANFACINE HYDROCHLORIDE SANDOZ INC Labeling Approval
07/30/2019 VECURONIUM BROMIDE
ANDA #203725
ORIG-1 VECURONIUM BROMIDE HIKMA Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #205430
SUPPL-1 GUANFACINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #205689
SUPPL-1 GUANFACINE HYDROCHLORIDE SUN PHARM Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #205689
SUPPL-4 GUANFACINE HYDROCHLORIDE SUN PHARM Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #205689
SUPPL-6 GUANFACINE HYDROCHLORIDE SUN PHARM Labeling Approval
07/30/2019 SIMVASTATIN
ANDA #206557
SUPPL-1 SIMVASTATIN HISUN PHARM HANGZHOU Labeling Approval
07/30/2019 SIMVASTATIN
ANDA #206557
SUPPL-3 SIMVASTATIN HISUN PHARM HANGZHOU Labeling Approval
07/30/2019 ENSTILAR
NDA #207589
SUPPL-5 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Efficacy Approval
07/30/2019 ENSTILAR
NDA #207589
SUPPL-6 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
07/30/2019 ENSTILAR
NDA #207589
SUPPL-7 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
07/30/2019 METRONIDAZOLE
ANDA #208162
SUPPL-6 METRONIDAZOLE STRIDES PHARMA Labeling Approval
07/30/2019 BACLOFEN
ANDA #210315
ORIG-1 BACLOFEN MAIA PHARMS INC Approval
07/30/2019 NUBEQA
NDA #212099
ORIG-1 DAROLUTAMIDE BAYER HEALTHCARE Type 1 - New Molecular Entity Approval
07/31/2019 SABRIL
NDA #020427
SUPPL-20 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
07/31/2019 ARRANON
NDA #021877
SUPPL-10 NELARABINE NOVARTIS Efficacy Approval
07/31/2019 SABRIL
NDA #022006
SUPPL-22 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
07/31/2019 ESBRIET
NDA #022535
SUPPL-12 PIRFENIDONE GENENTECH INC Labeling Approval
07/31/2019 CAMPATH
BLA #103948
SUPPL-5172 ALEMTUZUMAB GENZYME Approval
07/31/2019 LEMTRADA
BLA #103948
SUPPL-5172 ALEMTUZUMAB GENZYME Approval
07/31/2019 CYRAMZA
BLA #125477
SUPPL-33 RAMUCIRUMAB ELI LILLY AND CO Approval
07/31/2019 STIVARGA
NDA #203085
SUPPL-10 REGORAFENIB BAYER HLTHCARE Labeling Approval
07/31/2019 COLCHICINE
ANDA #204461
ORIG-1 COLCHICINE WATSON LABS INC Approval
07/31/2019 ESBRIET
NDA #208780
SUPPL-2 PIRFENIDONE GENENTECH INC 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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