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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 2019

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 16, 2024.

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 MSD SUB MERCK 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 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 MSD SUB MERCK 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 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 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 MSD SUB MERCK 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 Labeling Approval
07/02/2019 ITRACONAZOLE
ANDA #206410		 ORIG-1 ITRACONAZOLE STRIDES PHARMA Approval
07/02/2019 TRAMADOL HYDROCHLORIDE
ANDA #206706		 ORIG-1 TRAMADOL HYDROCHLORIDE MERRO PHARM USA Approval
07/02/2019 MISOPROSTOL
ANDA #210201		 ORIG-1 MISOPROSTOL ACQ PHARMA Approval
07/02/2019 ERYTHROMYCIN
ANDA #210954		 ORIG-1 ERYTHROMYCIN AMNEAL PHARMS CO Approval
07/02/2019 METRONIDAZOLE
ANDA #211786		 ORIG-1 METRONIDAZOLE PADAGIS ISRAEL Approval
07/02/2019 CARBOPROST TROMETHAMINE
ANDA #211941		 ORIG-1 CARBOPROST TROMETHAMINE DR REDDYS Approval
07/03/2019 ADDERALL XR 10
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/03/2019 ADDERALL XR 15
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/03/2019 ADDERALL XR 20
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/03/2019 ADDERALL XR 25
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/03/2019 ADDERALL XR 30
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/03/2019 ADDERALL XR 5
NDA #021303		 SUPPL-34 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA 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 TRIENTINE HYDROCHLORIDE
ANDA #211076		 ORIG-1 TRIENTINE HYDROCHLORIDE DR REDDYS 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
BLA #022505		 SUPPL-12 TESAMORELIN ACETATE THERATECHNOLOGIES Approval
07/05/2019 EGRIFTA
BLA #022505		 SUPPL-13 TESAMORELIN ACETATE THERATECHNOLOGIES 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 JUBILANT CADISTA Labeling Approval
07/05/2019 AZITHROMYCIN
ANDA #210000		 SUPPL-3 AZITHROMYCIN BIONPHARMA Labeling Approval
07/05/2019 AZITHROMYCIN
ANDA #210001		 SUPPL-3 AZITHROMYCIN BIONPHARMA 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 VORICONAZOLE
ANDA #200265		 SUPPL-10 VORICONAZOLE SANDOZ INC Labeling Approval
07/08/2019 VORICONAZOLE
ANDA #200265		 SUPPL-12 VORICONAZOLE SANDOZ INC 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 AZURITY 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 HALEON US HOLDINGS Labeling Approval
07/09/2019 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113		 SUPPL-7 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
07/09/2019 ADVIL CONGESTION RELIEF
NDA #022565		 SUPPL-5 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS 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 PHARMS INC Labeling Approval
07/09/2019 REBIF
BLA #103780		 SUPPL-5204 INTERFERON BETA-1A SERONO INC Approval
07/09/2019 DOCETAXEL
NDA #203551		 SUPPL-7 DOCETAXEL ACTAVIS Labeling Approval
07/09/2019 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203895		 SUPPL-2 BUPIVACAINE HYDROCHLORIDE EUGIA PHARMA 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 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 INC Labeling Approval
07/10/2019 TRIFERIC
NDA #206317		 SUPPL-12 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
07/10/2019 POKONZA
NDA #208019		 SUPPL-2 POTASSIUM CHLORIDE PHARMA RES SOFTWARE Labeling Approval
07/10/2019 POTASSIUM CHLORIDE
NDA #208019		 SUPPL-2 POTASSIUM CHLORIDE PHARMA RES SOFTWARE Labeling Approval
07/10/2019 ABIRATERONE ACETATE
ANDA #210686		 ORIG-1 ABIRATERONE ACETATE MSN Approval
07/10/2019 CYCLOSPORINE
ANDA #210721		 ORIG-1 CYCLOSPORINE APOTEX 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 VIATRIS Labeling Approval
07/12/2019 DILANTIN-30
NDA #008762		 SUPPL-63 PHENYTOIN VIATRIS 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 HIKMA 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 SUN PHARM INDS INC Approval
07/12/2019 ACYCLOVIR
ANDA #209000		 SUPPL-1 ACYCLOVIR ALEMBIC 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 SODIUM REDHILL Labeling Approval
07/12/2019 ETHACRYNIC ACID
ANDA #211809		 ORIG-1 ETHACRYNIC ACID AGNITIO 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 STRIDES PHARMA Approval
07/15/2019 IMBRUVICA
NDA #205552		 SUPPL-28 IBRUTINIB PHARMACYCLICS LLC 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 LLC Labeling Approval
07/16/2019 PENTASA
NDA #020049		 SUPPL-32 MESALAMINE TAKEDA PHARMS USA 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 STRIDES PHARMA 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 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 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 KARO HLTHCARE 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 PROVEPHARM SAS Approval
07/18/2019 PROSTIN VR PEDIATRIC
NDA #018484		 SUPPL-28 ALPROSTADIL PFIZER 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 KARO HLTHCARE Manufacturing (CMC) Approval
07/18/2019 LIALDA
NDA #022000		 SUPPL-18 MESALAMINE TAKEDA PHARMS USA Labeling Approval
07/18/2019 OLMESARTAN MEDOXOMIL
ANDA #207135		 ORIG-1 OLMESARTAN MEDOXOMIL UMEDICA 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 Approval
07/19/2019 OTEZLA
NDA #205437		 SUPPL-7 APREMILAST AMGEN INC 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 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 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 DRIZALMA SPRINKLE
NDA #212516		 ORIG-1 DULOXETINE HYDROCHLORIDE SUN PHARM 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 Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141		 SUPPL-2 MEROPENEM GLAND Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141		 SUPPL-3 MEROPENEM GLAND Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141		 SUPPL-4 MEROPENEM GLAND Labeling Approval
07/21/2019 MEROPENEM
ANDA #206141		 SUPPL-5 MEROPENEM GLAND Labeling Approval
07/22/2019 DROXIA
NDA #016295		 SUPPL-51 HYDROXYUREA CHEPLAPHARM Labeling Approval
07/22/2019 HYDREA
NDA #016295		 SUPPL-51 HYDROXYUREA CHEPLAPHARM 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 TWI PHARMS 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 STRIDES PHARMA Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070330		 SUPPL-39 IBUPROFEN STRIDES PHARMA Labeling Approval
07/22/2019 IBUPROFEN
ANDA #070986		 SUPPL-34 IBUPROFEN STRIDES PHARMA 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 PADAGIS US Labeling Approval
07/22/2019 IBUPROFEN
ANDA #077114		 SUPPL-13 IBUPROFEN L PERRIGO CO Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454		 SUPPL-4 HYDROCODONE BITARTRATE; IBUPROFEN ANI PHARMS Labeling Approval
07/22/2019 HYDROCODONE
ANDA #077723		 SUPPL-26 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC Labeling Approval
07/22/2019 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077723		 SUPPL-26 HYDROCODONE BITARTRATE; IBUPROFEN NOSTRUM LABS INC 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 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 ORBION PHARMS Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052		 SUPPL-3 PANTOPRAZOLE SODIUM ORBION PHARMS Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052		 SUPPL-5 PANTOPRAZOLE SODIUM ORBION PHARMS Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052		 SUPPL-6 PANTOPRAZOLE SODIUM ORBION PHARMS Labeling Approval
07/22/2019 PANTOPRAZOLE SODIUM
ANDA #202052		 SUPPL-7 PANTOPRAZOLE SODIUM ORBION PHARMS 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 SUNSHINE 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 PAI HOLDINGS PHARM Labeling Approval
07/22/2019 ILOPERIDONE
ANDA #207098		 ORIG-1 ILOPERIDONE TARO 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 HIKMA 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 RISING 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 Labeling Approval
07/23/2019 FULVESTRANT
ANDA #208811		 ORIG-1 FULVESTRANT EUGIA PHARMA 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 EUGIA PHARMA 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 AMPHASTAR PHARMS INC 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 Labeling Approval
07/25/2019 FERRIPROX
NDA #021825		 SUPPL-4 DEFERIPRONE CHIESI 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 MEITHEAL Labeling Approval
07/25/2019 DESMOPRESSIN ACETATE
ANDA #074888		 SUPPL-27 DESMOPRESSIN ACETATE MEITHEAL 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 HIKMA Labeling Approval
07/25/2019 FAMCICLOVIR
ANDA #090128		 SUPPL-5 FAMCICLOVIR HIKMA 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 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 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 Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573		 SUPPL-11 VENETOCLAX ABBVIE Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573		 SUPPL-14 VENETOCLAX ABBVIE Labeling Approval
07/25/2019 VENCLEXTA
NDA #208573		 SUPPL-15 VENETOCLAX ABBVIE Labeling Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-2 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-3 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-4 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-5 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-6 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-7 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
07/25/2019 BYDUREON BCISE
NDA #209210		 SUPPL-8 EXENATIDE SYNTHETIC 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 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 PIPERACILLIN AND TAZOBACTAM
ANDA #212287		 ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ASTRAL Approval
07/30/2019 VPRIV
BLA #022575		 SUPPL-22 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
07/30/2019 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070581		 SUPPL-44 METOCLOPRAMIDE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
07/30/2019 IRBESARTAN
ANDA #090201		 SUPPL-5 IRBESARTAN HIKMA 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 RISING Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #202568		 SUPPL-2 GUANFACINE HYDROCHLORIDE SANDOZ Labeling Approval
07/30/2019 GUANFACINE HYDROCHLORIDE
ANDA #202568		 SUPPL-3 GUANFACINE HYDROCHLORIDE SANDOZ 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 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 INVAGEN PHARMS Labeling Approval
07/30/2019 SIMVASTATIN
ANDA #206557		 SUPPL-3 SIMVASTATIN INVAGEN PHARMS 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 SANDOZ 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
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