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 |