02/01/2019 |
KUVAN NDA #022181 |
SUPPL-17 |
SAPROPTERIN DIHYDROCHLORIDE |
BIOMARIN PHARM |
Labeling |
Approval |
02/01/2019 |
AZITHROMYCIN ANDA #065209 |
SUPPL-25 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
02/01/2019 |
AZITHROMYCIN ANDA #065209 |
SUPPL-26 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #078964 |
SUPPL-4 |
RABEPRAZOLE SODIUM |
LUPIN LTD |
Labeling |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #078964 |
SUPPL-7 |
RABEPRAZOLE SODIUM |
LUPIN LTD |
Labeling |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #078964 |
SUPPL-9 |
RABEPRAZOLE SODIUM |
LUPIN LTD |
Labeling |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #078964 |
SUPPL-11 |
RABEPRAZOLE SODIUM |
LUPIN LTD |
Labeling |
Approval |
02/01/2019 |
OPDIVO BLA #125554 |
SUPPL-72 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
02/01/2019 |
XARELTO NDA #202439 |
SUPPL-29 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
02/01/2019 |
OPSUMIT NDA #204410 |
SUPPL-18 |
MACITENTAN |
ACTELION PHARMS LTD |
REMS |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #205761 |
SUPPL-2 |
RABEPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/01/2019 |
RABEPRAZOLE SODIUM ANDA #205761 |
SUPPL-3 |
RABEPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/01/2019 |
DICYCLOMINE HYDROCHLORIDE ANDA #206468 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
NEXUS PHARMS |
|
Approval |
02/01/2019 |
OXYCODONE HYDROCHLORIDE ANDA #206914 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
PHARM ASSOC |
|
Approval |
02/01/2019 |
PREGABALIN ANDA #207623 |
ORIG-1 |
PREGABALIN |
ALKEM LABS LTD |
|
Tentative Approval |
02/01/2019 |
XULTOPHY 100/3.6 NDA #208583 |
SUPPL-2 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
Efficacy |
Approval |
02/01/2019 |
XULTOPHY 100/3.6 NDA #208583 |
SUPPL-3 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
Efficacy |
Approval |
02/01/2019 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #208737 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
CEDIPROF INC |
|
Approval |
02/01/2019 |
APIXABAN ANDA #210013 |
ORIG-1 |
APIXABAN |
MICRO LABS LTD |
|
Tentative Approval |
02/01/2019 |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE NDA #210787 |
ORIG-1 |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
LAURUS LABS LTD |
Type 4 - New Combination |
Tentative Approval |
02/01/2019 |
BACLOFEN ANDA #211555 |
ORIG-1 |
BACLOFEN |
EYWA PHARMA |
|
Approval |
02/01/2019 |
JEUVEAU BLA #761085 |
ORIG-1 |
PRABOTULINUMTOXINA-XVFS |
EVOLUS INC |
|
Approval |
02/02/2019 |
METFORMIN HYDROCHLORIDE ANDA #076033 |
SUPPL-16 |
METFORMIN HYDROCHLORIDE |
ATLAS PHARMS LLC |
Labeling |
Approval |
02/02/2019 |
METFORMIN HYDROCHLORIDE ANDA #076033 |
SUPPL-20 |
METFORMIN HYDROCHLORIDE |
ATLAS PHARMS LLC |
Labeling |
Approval |
02/02/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090362 |
SUPPL-7 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SUN PHARMA GLOBAL |
Labeling |
Approval |
02/02/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #090362 |
SUPPL-8 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SUN PHARMA GLOBAL |
Labeling |
Approval |
02/02/2019 |
METFORMIN HYDROCHLORIDE ANDA #091184 |
SUPPL-10 |
METFORMIN HYDROCHLORIDE |
ALKEM |
Labeling |
Approval |
02/02/2019 |
METFORMIN HYDROCHLORIDE ANDA #091184 |
SUPPL-12 |
METFORMIN HYDROCHLORIDE |
ALKEM |
Labeling |
Approval |
02/02/2019 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #202414 |
SUPPL-17 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
02/02/2019 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #202414 |
SUPPL-24 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
02/02/2019 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #202414 |
SUPPL-17 |
IRBESARTAN: HYDROCHLOROTHIAZIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
02/02/2019 |
IRBESARTAN; HYDROCHLOROTHIAZIDE ANDA #202414 |
SUPPL-24 |
IRBESARTAN: HYDROCHLOROTHIAZIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
02/04/2019 |
ANTARA (MICRONIZED) NDA #021695 |
SUPPL-18 |
FENOFIBRATE |
LUPIN ATLANTIS |
Manufacturing (CMC) |
Approval |
02/04/2019 |
ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089673 |
SUPPL-27 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
RHODES PHARMS |
REMS |
Approval |
02/04/2019 |
POTASSIUM CHLORIDE NDA #206814 |
SUPPL-7 |
POTASSIUM CHLORIDE |
GENUS LIFESCIENCES |
Labeling |
Approval |
02/04/2019 |
LABETALOL HYDROCHLORIDE ANDA #207863 |
ORIG-1 |
LABETALOL HYDROCHLORIDE |
INVATECH PHARMA |
|
Approval |
02/04/2019 |
VEMLIDY NDA #208464 |
SUPPL-7 |
TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
02/04/2019 |
ACYCLOVIR ANDA #208702 |
ORIG-1 |
ACYCLOVIR |
PERRIGO UK FINCO |
|
Approval |
02/04/2019 |
XEPI NDA #208945 |
SUPPL-1 |
OZENOXACIN |
FERRER INTERNACIONAL |
Labeling |
Approval |
02/04/2019 |
LEVOMILNACIPRAN HYDROCHLORIDE ANDA #210790 |
ORIG-1 |
LEVOMILNACIPRAN HYDROCHLORIDE |
AMNEAL PHARMS CO |
|
Approval |
02/04/2019 |
DAPAGLIFLOZIN ANDA #211541 |
ORIG-1 |
DAPAGLIFLOZIN |
TEVA PHARMS USA INC |
|
Tentative Approval |
02/04/2019 |
OXYCODONE HYDROCHLORIDE ANDA #211749 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
02/04/2019 |
FEBUXOSTAT ANDA #211837 |
ORIG-1 |
FEBUXOSTAT |
TORRENT PHARMS LTD |
|
Tentative Approval |
02/05/2019 |
AVANDIA NDA #021071 |
SUPPL-52 |
ROSIGLITAZONE MALEATE |
SB PHARMCO |
Labeling |
Approval |
02/05/2019 |
LEVOFLOXACIN ANDA #204968 |
ORIG-1 |
LEVOFLOXACIN |
HEC PHARM |
|
Approval |
02/05/2019 |
TADALAFIL ANDA #206286 |
ORIG-1 |
TADALAFIL |
AUROBINDO PHARMA LTD |
|
Approval |
02/05/2019 |
FULVESTRANT ANDA #207754 |
ORIG-1 |
FULVESTRANT |
GLENMARK PHARMS INC |
|
Tentative Approval |
02/05/2019 |
DYANAVEL XR NDA #208147 |
SUPPL-5 |
AMPHETAMINE |
TRIS PHARMA INC |
Efficacy |
Approval |
02/05/2019 |
TADALAFIL ANDA #209907 |
ORIG-1 |
TADALAFIL |
HETERO LABS LTD III |
|
Approval |
02/05/2019 |
ALYQ ANDA #209942 |
ORIG-1 |
TADALAFIL |
TEVA PHARMS USA |
|
Approval |
02/05/2019 |
TADALAFIL ANDA #210145 |
ORIG-1 |
TADALAFIL |
DR REDDYS LABS LTD |
|
Approval |
02/05/2019 |
TADALAFIL ANDA #210255 |
ORIG-1 |
TADALAFIL |
CIPLA |
|
Approval |
02/05/2019 |
TADALAFIL ANDA #210392 |
ORIG-1 |
TADALAFIL |
AJANTA PHARMA LTD |
|
Approval |
02/05/2019 |
TADALAFIL ANDA #210572 |
ORIG-1 |
TADALAFIL |
LUPIN LTD |
|
Approval |
02/05/2019 |
ESTRADIOL ANDA #211293 |
ORIG-1 |
ESTRADIOL |
AMNEAL PHARMS LLC |
|
Approval |
02/06/2019 |
BUTISOL SODIUM NDA #000793 |
SUPPL-26 |
BUTABARBITAL SODIUM |
MYLAN SPECIALITY LP |
Labeling |
Approval |
02/06/2019 |
HALCION NDA #017892 |
SUPPL-54 |
TRIAZOLAM |
PHARMACIA AND UPJOHN |
Labeling |
Approval |
02/06/2019 |
RESTORIL NDA #018163 |
SUPPL-65 |
TEMAZEPAM |
SPECGX LLC |
Labeling |
Approval |
02/06/2019 |
DORAL NDA #018708 |
SUPPL-25 |
QUAZEPAM |
GALT PHARMS |
Labeling |
Approval |
02/06/2019 |
CLARITIN NDA #019658 |
SUPPL-56 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
02/06/2019 |
CLARITIN HIVES RELIEF NDA #019658 |
SUPPL-56 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
02/06/2019 |
AMBIEN NDA #019908 |
SUPPL-45 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
02/06/2019 |
SONATA NDA #020859 |
SUPPL-15 |
ZALEPLON |
PFIZER |
Labeling |
Approval |
02/06/2019 |
LUNESTA NDA #021476 |
SUPPL-37 |
ESZOPICLONE |
SUNOVION PHARMS INC |
Labeling |
Approval |
02/06/2019 |
AMBIEN CR NDA #021774 |
SUPPL-26 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
02/06/2019 |
EDLUAR NDA #021997 |
SUPPL-10 |
ZOLPIDEM TARTRATE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
02/06/2019 |
ZOLPIMIST NDA #022196 |
SUPPL-11 |
ZOLPIDEM TARTRATE |
MAGNA PHARMS |
Labeling |
Approval |
02/06/2019 |
INTERMEZZO NDA #022328 |
SUPPL-7 |
ZOLPIDEM TARTRATE |
PURDUE PHARMA |
Labeling |
Approval |
02/06/2019 |
FLURAZEPAM HYDROCHLORIDE ANDA #070345 |
SUPPL-20 |
FLURAZEPAM HYDROCHLORIDE |
MYLAN PHARMS INC |
Labeling |
Approval |
02/06/2019 |
FLURAZEPAM HYDROCHLORIDE ANDA #070454 |
SUPPL-19 |
FLURAZEPAM HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
02/06/2019 |
FLURAZEPAM HYDROCHLORIDE ANDA #070455 |
SUPPL-19 |
FLURAZEPAM HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
02/06/2019 |
FLURAZEPAM HYDROCHLORIDE ANDA #072368 |
SUPPL-6 |
FLURAZEPAM HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
02/06/2019 |
ESTAZOLAM ANDA #074826 |
SUPPL-18 |
ESTAZOLAM |
PAR PHARM |
Labeling |
Approval |
02/06/2019 |
ESTAZOLAM ANDA #074921 |
SUPPL-16 |
ESTAZOLAM |
MAYNE PHARMA |
Labeling |
Approval |
02/06/2019 |
NEMBUTAL SODIUM ANDA #083245 |
SUPPL-14 |
PENTOBARBITAL SODIUM |
OAK PHARMS |
Labeling |
Approval |
02/06/2019 |
NEMBUTAL SODIUM ANDA #084093 |
SUPPL-12 |
PENTOBARBITAL SODIUM |
OAK PHARMS |
Labeling |
Approval |
02/06/2019 |
NEMBUTAL SODIUM ANDA #084095 |
SUPPL-8 |
PENTOBARBITAL SODIUM |
OAK PHARMS |
Labeling |
Approval |
02/06/2019 |
SODIUM BUTABARBITAL ANDA #085849 |
SUPPL-6 |
BUTABARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
SODIUM BUTABARBITAL ANDA #085866 |
SUPPL-7 |
BUTABARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
BUTALAN ANDA #085880 |
SUPPL-1 |
BUTABARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
SODIUM BUTABARBITAL ANDA #085881 |
SUPPL-5 |
BUTABARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
PENTOBARBITAL SODIUM ANDA #085915 |
SUPPL-3 |
PENTOBARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
PENTOBARBITAL SODIUM ANDA #085937 |
SUPPL-3 |
PENTOBARBITAL SODIUM |
LANNETT |
Labeling |
Approval |
02/06/2019 |
SYLEVIA ANDA #202988 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
SUN PHARM INDS LTD |
|
Approval |
02/06/2019 |
STRIBILD NDA #203100 |
SUPPL-34 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
02/06/2019 |
NALBUPHINE HYDROCHLORIDE ANDA #206506 |
ORIG-1 |
NALBUPHINE HYDROCHLORIDE |
MYLAN LABS LTD |
|
Approval |
02/06/2019 |
OXYBUTYNIN CHLORIDE ANDA #211062 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
INVATECH PHARMA |
|
Approval |
02/06/2019 |
CABLIVI BLA #761112 |
ORIG-1 |
CAPLACIZUMAB-YHDP |
ABLYNX NV |
|
Approval |
02/07/2019 |
DIFLUCAN NDA #019949 |
SUPPL-65 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
02/07/2019 |
DIFLUCAN NDA #020090 |
SUPPL-47 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #076885 |
SUPPL-4 |
RABEPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #076885 |
SUPPL-5 |
RABEPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #076885 |
SUPPL-6 |
RABEPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #076885 |
SUPPL-8 |
RABEPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
02/07/2019 |
BICALUTAMIDE ANDA #078634 |
SUPPL-6 |
BICALUTAMIDE |
WATSON LABS TEVA |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #090678 |
SUPPL-5 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #090678 |
SUPPL-6 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #090678 |
SUPPL-7 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
02/07/2019 |
RABEPRAZOLE SODIUM ANDA #090678 |
SUPPL-10 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
02/07/2019 |
DESVENLAFAXINE ANDA #204805 |
ORIG-1 |
DESVENLAFAXINE |
INTELLIPHARMACEUTICS |
|
Tentative Approval |
02/07/2019 |
CARBAMAZEPINE ANDA #205571 |
ORIG-1 |
CARBAMAZEPINE |
ZYDUS PHARMS USA INC |
|
Approval |
02/07/2019 |
FINGOLIMOD ANDA #207983 |
ORIG-1 |
FINGOLIMOD |
AUROBINDO PHARMA LTD |
|
Tentative Approval |
02/07/2019 |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE ANDA #209281 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
ACCORD HLTHCARE |
|
Approval |
02/07/2019 |
ESKATA NDA #209305 |
SUPPL-1 |
HYDROGEN PEROXIDE |
ACLARIS |
Labeling |
Approval |
02/08/2019 |
CANCIDAS NDA #021227 |
SUPPL-39 |
CASPOFUNGIN ACETATE |
MERCK |
Labeling |
Approval |
02/08/2019 |
DOXYCYCLINE ANDA #203278 |
ORIG-1 |
DOXYCYCLINE |
AMNEAL PHARMS |
|
Tentative Approval |
02/08/2019 |
DEFERIPRONE ANDA #208800 |
ORIG-1 |
DEFERIPRONE |
TARO PHARM INDS |
|
Approval |
02/08/2019 |
APIXABAN ANDA #209944 |
ORIG-1 |
APIXABAN |
SUNSHINE LAKE |
|
Tentative Approval |
02/08/2019 |
ESTRADIOL ANDA #211396 |
ORIG-1 |
ESTRADIOL |
AMNEAL PHARMS |
|
Tentative Approval |
02/08/2019 |
DARZALEX BLA #761036 |
SUPPL-16 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
02/11/2019 |
VANTAS NDA #021732 |
SUPPL-22 |
HISTRELIN ACETATE |
ENDO PHARM |
Labeling |
Approval |
02/11/2019 |
NOVOLOG MIX 50/50 NDA #021810 |
SUPPL-15 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
Labeling |
Approval |
02/11/2019 |
CAYSTON NDA #050814 |
SUPPL-21 |
AZTREONAM |
GILEAD |
Labeling |
Approval |
02/11/2019 |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE ANDA #208358 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; TRIAMTERENE |
ZYDUS PHARMS USA INC |
|
Approval |
02/11/2019 |
LO-MALMOREDE ANDA #209548 |
ORIG-1 |
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE |
NOVAST LABS |
|
Approval |
02/11/2019 |
FENOFIBRATE ANDA #209660 |
ORIG-1 |
FENOFIBRATE |
ORIT LABS LLC |
|
Approval |
02/11/2019 |
OMEPRAZOLE ANDA #210070 |
ORIG-1 |
OMEPRAZOLE |
APOTEX INC |
|
Approval |
02/11/2019 |
TRIAMCINOLONE ACETONIDE ANDA #210346 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
STRIDES PHARMA |
|
Approval |
02/11/2019 |
DICYCLOMINE HYDROCHLORIDE ANDA #210788 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
CUSTOPHARM INC |
|
Approval |
02/12/2019 |
ANCOBON NDA #017001 |
SUPPL-33 |
FLUCYTOSINE |
VALEANT |
Labeling |
Approval |
02/12/2019 |
LINEZOLID ANDA #078845 |
SUPPL-1 |
LINEZOLID |
MYLAN PHARMS INC |
Labeling |
Approval |
02/12/2019 |
LINEZOLID ANDA #078845 |
SUPPL-2 |
LINEZOLID |
MYLAN PHARMS INC |
Labeling |
Approval |
02/12/2019 |
AZACITIDINE ANDA #204949 |
SUPPL-2 |
AZACITIDINE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
02/12/2019 |
AZACITIDINE ANDA #204949 |
SUPPL-3 |
AZACITIDINE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
02/12/2019 |
MYCOPHENOLATE MOFETIL ANDA #210370 |
ORIG-1 |
MYCOPHENOLATE MOFETIL |
VISTAPHARM |
|
Approval |
02/13/2019 |
INOMAX NDA #020845 |
SUPPL-20 |
NITRIC OXIDE |
MALLINCKRODT HOSP |
Labeling |
Approval |
02/13/2019 |
EMBELINE ANDA #074221 |
SUPPL-8 |
CLOBETASOL PROPIONATE |
HI TECH PHARMA |
Manufacturing (CMC) |
Approval |
02/13/2019 |
CIMETIDINE HYDROCHLORIDE ANDA #074664 |
SUPPL-2 |
CIMETIDINE HYDROCHLORIDE |
HI TECH PHARMA |
Manufacturing (CMC) |
Approval |
02/13/2019 |
OFLOXACIN ANDA #076513 |
SUPPL-21 |
OFLOXACIN |
APOTEX INC |
Manufacturing (CMC) |
Approval |
02/13/2019 |
EGATEN NDA #208711 |
ORIG-1 |
TRICLABENDAZOLE |
NOVARTIS PHARMS CORP |
Type 1 - New Molecular Entity |
Approval |
02/13/2019 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #209469 |
ORIG-1 |
MOXIFLOXACIN HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
|
Approval |
02/13/2019 |
FLUOCINOLONE ACETONIDE ANDA #209913 |
ORIG-1 |
FLUOCINOLONE ACETONIDE |
ENCUBE ETHICALS |
|
Approval |
02/13/2019 |
KISQALI FEMARA CO-PACK (COPACKAGED) NDA #209935 |
SUPPL-2 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS PHARMS CORP |
Efficacy |
Approval |
02/14/2019 |
M.V.I. PEDIATRIC NDA #018920 |
SUPPL-38 |
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E |
HOSPIRA |
Labeling |
Approval |
02/14/2019 |
SPIRIVA RESPIMAT NDA #021936 |
SUPPL-12 |
TIOTROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
02/14/2019 |
AZITHROMYCIN ANDA #065211 |
SUPPL-30 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
02/14/2019 |
AZITHROMYCIN ANDA #065212 |
SUPPL-28 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
02/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #077095 |
SUPPL-23 |
METFORMIN HYDROCHLORIDE |
AUROBINDO |
Labeling |
Approval |
02/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #077095 |
SUPPL-24 |
METFORMIN HYDROCHLORIDE |
AUROBINDO |
Labeling |
Approval |
02/14/2019 |
ENBREL BLA #103795 |
SUPPL-5571 |
ETANERCEPT |
IMMUNEX |
|
Approval |
02/14/2019 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #205630 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN LTD |
Labeling |
Approval |
02/14/2019 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #205630 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
02/14/2019 |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE ANDA #210676 |
ORIG-1 |
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN |
AUROBINDO PHARMA LTD |
|
Approval |
02/15/2019 |
KEYTRUDA BLA #125514 |
SUPPL-40 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |