02/02/2020 |
INDOMETHACIN ANDA #074464 |
SUPPL-19 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
02/02/2020 |
INDOMETHACIN ANDA #074464 |
SUPPL-20 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
02/02/2020 |
RIZATRIPTAN BENZOATE ANDA #077263 |
SUPPL-5 |
RIZATRIPTAN BENZOATE |
TEVA PHARMS |
Labeling |
Approval |
02/02/2020 |
INDOMETHACIN ANDA #091276 |
SUPPL-3 |
INDOMETHACIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/02/2020 |
INDOMETHACIN ANDA #091276 |
SUPPL-4 |
INDOMETHACIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/02/2020 |
INDOMETHACIN ANDA #091549 |
SUPPL-9 |
INDOMETHACIN |
AMNEAL PHARMS |
Labeling |
Approval |
02/02/2020 |
KINERET BLA #103950 |
SUPPL-5183 |
ANAKINRA |
BIOVITRUM AB |
|
Approval |
02/03/2020 |
FARXIGA NDA #202293 |
SUPPL-22 |
DAPAGLIFLOZIN |
ASTRAZENECA AB |
Labeling |
Approval |
02/03/2020 |
OCTREOTIDE ACETATE ANDA #203765 |
SUPPL-1 |
OCTREOTIDE ACETATE |
HERITAGE |
Labeling |
Approval |
02/03/2020 |
OCTREOTIDE ACETATE ANDA #204669 |
SUPPL-1 |
OCTREOTIDE ACETATE |
HERITAGE |
Labeling |
Approval |
02/03/2020 |
DECITABINE NDA #205582 |
SUPPL-12 |
DECITABINE |
SUN PHARM |
Labeling |
Approval |
02/03/2020 |
XIGDUO XR NDA #205649 |
SUPPL-14 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
ASTRAZENECA AB |
Labeling |
Approval |
02/03/2020 |
CALCITRIOL ANDA #211030 |
ORIG-1 |
CALCITRIOL |
GLAND PHARMA LTD |
|
Approval |
02/03/2020 |
CYCLOPHOSPHAMIDE ANDA #211608 |
SUPPL-2 |
CYCLOPHOSPHAMIDE |
CIPLA |
Labeling |
Approval |
02/04/2020 |
ORAVIG NDA #022404 |
SUPPL-5 |
MICONAZOLE |
GALT PHARMS |
Labeling |
Approval |
02/04/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #077437 |
SUPPL-5 |
MOXIFLOXACIN HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
02/04/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #077437 |
SUPPL-6 |
MOXIFLOXACIN HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
02/04/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #077437 |
SUPPL-8 |
MOXIFLOXACIN HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
02/04/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #077437 |
SUPPL-9 |
MOXIFLOXACIN HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
02/04/2020 |
EFAVIRENZ ANDA #077673 |
SUPPL-16 |
EFAVIRENZ |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
EFAVIRENZ ANDA #078064 |
SUPPL-14 |
EFAVIRENZ |
AUROBINDO PHARMA |
Labeling |
Approval |
02/04/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #083329 |
SUPPL-46 |
CHLORPROMAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
02/04/2020 |
ARIPIPRAZOLE ANDA #090165 |
SUPPL-1 |
ARIPIPRAZOLE |
SQUARE PHARMS |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-17 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-18 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-19 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-20 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-21 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-25 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
DIVALPROEX SODIUM ANDA #090554 |
SUPPL-27 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
PANTOPRAZOLE SODIUM ANDA #090901 |
SUPPL-15 |
PANTOPRAZOLE SODIUM |
JUBILANT GENERICS |
Labeling |
Approval |
02/04/2020 |
PANTOPRAZOLE SODIUM ANDA #090901 |
SUPPL-17 |
PANTOPRAZOLE SODIUM |
JUBILANT GENERICS |
Labeling |
Approval |
02/04/2020 |
PANTOPRAZOLE SODIUM ANDA #090901 |
SUPPL-22 |
PANTOPRAZOLE SODIUM |
JUBILANT GENERICS |
Labeling |
Approval |
02/04/2020 |
OXACILLIN SODIUM ANDA #091486 |
SUPPL-1 |
OXACILLIN SODIUM |
STERISCIENCE SPECLTS |
Labeling |
Approval |
02/04/2020 |
VYFEMLA ANDA #201886 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
02/04/2020 |
BUSPIRONE HYDROCHLORIDE ANDA #202087 |
SUPPL-3 |
BUSPIRONE HYDROCHLORIDE |
AIPING PHARM INC |
Manufacturing (CMC) |
Approval |
02/04/2020 |
ARIPIPRAZOLE ANDA #202102 |
SUPPL-16 |
ARIPIPRAZOLE |
ALEMBIC |
Labeling |
Approval |
02/04/2020 |
VEMLIDY NDA #208464 |
SUPPL-8 |
TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
02/04/2020 |
SUBLOCADE NDA #209819 |
SUPPL-12 |
BUPRENORPHINE |
INDIVIOR |
Labeling |
Approval |
02/04/2020 |
ARIPIPRAZOLE ANDA #210479 |
SUPPL-2 |
ARIPIPRAZOLE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/04/2020 |
LEFLUNOMIDE ANDA #211863 |
ORIG-1 |
LEFLUNOMIDE |
LUPIN LTD |
|
Approval |
02/04/2020 |
AMPHETAMINE SULFATE ANDA #212582 |
ORIG-1 |
AMPHETAMINE SULFATE |
CEROVENE INC |
|
Approval |
02/05/2020 |
LITHIUM CARBONATE NDA #017812 |
SUPPL-34 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/05/2020 |
LITHOBID NDA #018027 |
SUPPL-67 |
LITHIUM CARBONATE |
ANI PHARMS |
Labeling |
Approval |
02/05/2020 |
LITHIUM CITRATE NDA #018421 |
SUPPL-33 |
LITHIUM CITRATE |
HIKMA |
Labeling |
Approval |
02/05/2020 |
LITHIUM CARBONATE NDA #018558 |
SUPPL-28 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/05/2020 |
RISPERDAL NDA #020272 |
SUPPL-85 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
02/05/2020 |
RISPERDAL NDA #020588 |
SUPPL-72 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
02/05/2020 |
SEROQUEL NDA #020639 |
SUPPL-69 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
02/05/2020 |
RISPERDAL CONSTA NDA #021346 |
SUPPL-63 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021436 |
SUPPL-44 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021436 |
SUPPL-45 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
RISPERDAL NDA #021444 |
SUPPL-58 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021713 |
SUPPL-35 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021713 |
SUPPL-36 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021729 |
SUPPL-27 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021729 |
SUPPL-28 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021866 |
SUPPL-29 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY NDA #021866 |
SUPPL-30 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
SEROQUEL XR NDA #022047 |
SUPPL-43 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
02/05/2020 |
LITHIUM CARBONATE ANDA #076366 |
SUPPL-7 |
LITHIUM CARBONATE |
HERITAGE PHARMA |
Labeling |
Approval |
02/05/2020 |
LITHIUM CARBONATE ANDA #076490 |
SUPPL-12 |
LITHIUM CARBONATE |
HIKMA INTL PHARMS |
Labeling |
Approval |
02/05/2020 |
LITHIUM CARBONATE ANDA #076691 |
SUPPL-10 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/05/2020 |
LEVETIRACETAM ANDA #078858 |
SUPPL-24 |
LEVETIRACETAM |
TORRENT PHARMS |
Labeling |
Approval |
02/05/2020 |
LEVETIRACETAM ANDA #078858 |
SUPPL-26 |
LEVETIRACETAM |
TORRENT PHARMS |
Labeling |
Approval |
02/05/2020 |
LEVETIRACETAM ANDA #078858 |
SUPPL-27 |
LEVETIRACETAM |
TORRENT PHARMS |
Labeling |
Approval |
02/05/2020 |
LEVETIRACETAM ANDA #078858 |
SUPPL-31 |
LEVETIRACETAM |
TORRENT PHARMS |
Labeling |
Approval |
02/05/2020 |
LEVETIRACETAM ANDA #078858 |
SUPPL-32 |
LEVETIRACETAM |
TORRENT PHARMS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #080365 |
SUPPL-167 |
CHLORPROMAZINE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #080439 |
SUPPL-225 |
CHLORPROMAZINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
02/05/2020 |
SONAZINE ANDA #080983 |
SUPPL-61 |
CHLORPROMAZINE HYDROCHLORIDE |
FOSUN PHARMA |
Labeling |
Approval |
02/05/2020 |
SONAZINE ANDA #083040 |
SUPPL-44 |
CHLORPROMAZINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #083329 |
SUPPL-47 |
CHLORPROMAZINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #083386 |
SUPPL-98 |
CHLORPROMAZINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #084112 |
SUPPL-122 |
CHLORPROMAZINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #084113 |
SUPPL-122 |
CHLORPROMAZINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #084114 |
SUPPL-123 |
CHLORPROMAZINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #084115 |
SUPPL-112 |
CHLORPROMAZINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #090165 |
SUPPL-2 |
ARIPIPRAZOLE |
SQUARE PHARMS |
Labeling |
Approval |
02/05/2020 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #091332 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
02/05/2020 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #091332 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
02/05/2020 |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #091332 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
02/05/2020 |
LITHIUM CARBONATE ANDA #091616 |
SUPPL-9 |
LITHIUM CARBONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #202102 |
SUPPL-17 |
ARIPIPRAZOLE |
ALEMBIC |
Labeling |
Approval |
02/05/2020 |
LITHIUM CARBONATE ANDA #202219 |
SUPPL-4 |
LITHIUM CARBONATE |
MYLAN PHARMS INC |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #202547 |
SUPPL-1 |
ARIPIPRAZOLE |
ORBION PHARMS |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #202547 |
SUPPL-2 |
ARIPIPRAZOLE |
ORBION PHARMS |
Labeling |
Approval |
02/05/2020 |
ABILIFY MAINTENA KIT NDA #202971 |
SUPPL-13 |
ARIPIPRAZOLE |
OTSUKA PHARM CO LTD |
Labeling |
Approval |
02/05/2020 |
TECFIDERA NDA #204063 |
SUPPL-23 |
DIMETHYL FUMARATE |
BIOGEN INC |
Efficacy |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #204094 |
SUPPL-8 |
ARIPIPRAZOLE |
APOTEX |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #204171 |
SUPPL-4 |
ARIPIPRAZOLE |
LANNETT CO INC |
Labeling |
Approval |
02/05/2020 |
TRAZODONE HYDROCHLORIDE ANDA #204852 |
ORIG-1 |
TRAZODONE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
02/05/2020 |
ROCURONIUM BROMIDE ANDA #205656 |
SUPPL-3 |
ROCURONIUM BROMIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
02/05/2020 |
ROCURONIUM BROMIDE ANDA #205656 |
SUPPL-4 |
ROCURONIUM BROMIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
02/05/2020 |
ABILIFY MYCITE KIT NDA #207202 |
SUPPL-2 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ABILIFY MYCITE KIT NDA #207202 |
SUPPL-4 |
ARIPIPRAZOLE |
OTSUKA |
Labeling |
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #207240 |
SUPPL-5 |
ARIPIPRAZOLE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
02/05/2020 |
TICAGRELOR ANDA #208575 |
SUPPL-1 |
TICAGRELOR |
HISUN PHARM HANGZHOU |
Labeling |
Approval |
02/05/2020 |
TICAGRELOR ANDA #208575 |
SUPPL-2 |
TICAGRELOR |
HISUN PHARM HANGZHOU |
Labeling |
Approval |
02/05/2020 |
ZERVIATE NDA #208694 |
SUPPL-6 |
CETIRIZINE HYDROCHLORIDE |
HARROW EYE |
Labeling |
Approval |
02/05/2020 |
METOPROLOL TARTRATE ANDA #208955 |
ORIG-1 |
METOPROLOL TARTRATE |
YOUNGTECH PHARMS INC |
|
Approval |
02/05/2020 |
SODIUM IODIDE I 131 ANDA #209166 |
ORIG-1 |
SODIUM IODIDE I-131 |
INTL ISOTOPES |
|
Approval |
02/05/2020 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #209755 |
SUPPL-2 |
CHLORPROMAZINE HYDROCHLORIDE |
AMNEAL PHARMS CO |
Labeling |
Approval |
02/05/2020 |
COLCHICINE ANDA #210425 |
ORIG-1 |
COLCHICINE |
GRANULES |
|
Approval |
02/05/2020 |
ARIPIPRAZOLE ANDA #210479 |
SUPPL-4 |
ARIPIPRAZOLE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/05/2020 |
PERSERIS KIT NDA #210655 |
SUPPL-4 |
RISPERIDONE |
INDIVIOR |
Labeling |
Approval |
02/06/2020 |
JENLOGA NDA #022331 |
SUPPL-21 |
CLONIDINE HYDROCHLORIDE |
CONCORDIA PHARMS INC |
Labeling |
Approval |
02/06/2020 |
KAPVAY NDA #022331 |
SUPPL-21 |
CLONIDINE HYDROCHLORIDE |
CONCORDIA PHARMS INC |
Labeling |
Approval |
02/06/2020 |
TOBRAMYCIN ANDA #091589 |
SUPPL-9 |
TOBRAMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
02/06/2020 |
TOBRAMYCIN ANDA #091589 |
SUPPL-10 |
TOBRAMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
02/06/2020 |
ARIPIPRAZOLE ANDA #203906 |
SUPPL-8 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
02/06/2020 |
TECHNETIUM TC99M MERTIATIDE KIT ANDA #206489 |
ORIG-1 |
TECHNETIUM TC-99M MERTIATIDE KIT |
MEDI-RADIOPHARMA |
|
Approval |
02/06/2020 |
LEVALBUTEROL HYDROCHLORIDE ANDA #207625 |
SUPPL-4 |
LEVALBUTEROL HYDROCHLORIDE |
LUOXIN AUROVITAS |
Labeling |
Approval |
02/06/2020 |
TOBRAMYCIN ANDA #208964 |
SUPPL-3 |
TOBRAMYCIN |
LUPIN |
Labeling |
Approval |
02/06/2020 |
FLUDEOXYGLUCOSE F18 ANDA #210265 |
ORIG-1 |
FLUDEOXYGLUCOSE F-18 |
UNIV TX SW MEDCTR |
|
Approval |
02/07/2020 |
ACETAMINOPHEN NDA #018337 |
SUPPL-35 |
ACETAMINOPHEN |
TARO |
Labeling |
Approval |
02/07/2020 |
INFANTS' FEVERALL NDA #018337 |
SUPPL-35 |
ACETAMINOPHEN |
TARO |
Labeling |
Approval |
02/07/2020 |
OXACILLIN SODIUM ANDA #062798 |
SUPPL-1 |
OXACILLIN SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
02/07/2020 |
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ANDA #064063 |
SUPPL-41 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
BAUSCH AND LOMB |
Labeling |
Approval |
02/07/2020 |
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ANDA #064063 |
SUPPL-42 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
BAUSCH AND LOMB |
Labeling |
Approval |
02/07/2020 |
DEXASPORIN ANDA #064135 |
SUPPL-34 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
BAUSCH AND LOMB |
Labeling |
Approval |
02/07/2020 |
ZIDOVUDINE ANDA #090561 |
SUPPL-7 |
ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
02/07/2020 |
ZIDOVUDINE ANDA #090561 |
SUPPL-8 |
ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
02/07/2020 |
ZIDOVUDINE ANDA #090561 |
SUPPL-10 |
ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
02/07/2020 |
ZIDOVUDINE ANDA #090561 |
SUPPL-12 |
ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
02/07/2020 |
ZIDOVUDINE ANDA #090561 |
SUPPL-13 |
ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
02/07/2020 |
RAMELTEON ANDA #091610 |
SUPPL-2 |
RAMELTEON |
ACTAVIS LABS FL INC |
Labeling |
Approval |
02/07/2020 |
RAMELTEON ANDA #091693 |
SUPPL-2 |
RAMELTEON |
DR REDDYS LABS SA |
Labeling |
Approval |
02/07/2020 |
LEVALBUTEROL HYDROCHLORIDE ANDA #200875 |
SUPPL-6 |
LEVALBUTEROL HYDROCHLORIDE |
TEVA PARENTERAL |
Labeling |
Approval |
02/07/2020 |
LAMOTRIGINE ANDA #201374 |
SUPPL-2 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/07/2020 |
LAMOTRIGINE ANDA #201374 |
SUPPL-3 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/07/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #205348 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
CROSSMEDIKA SA |
Labeling |
Approval |
02/07/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #205348 |
SUPPL-2 |
MOXIFLOXACIN HYDROCHLORIDE |
CROSSMEDIKA SA |
Labeling |
Approval |
02/07/2020 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #205348 |
SUPPL-4 |
MOXIFLOXACIN HYDROCHLORIDE |
CROSSMEDIKA SA |
Labeling |
Approval |
02/07/2020 |
DRONABINOL ANDA #207421 |
ORIG-1 |
DRONABINOL |
ASCENT PHARMS INC |
|
Approval |
02/07/2020 |
LEVALBUTEROL HYDROCHLORIDE ANDA #207628 |
SUPPL-4 |
LEVALBUTEROL HYDROCHLORIDE |
LUOXIN AUROVITAS |
Labeling |
Approval |
02/07/2020 |
ZYPITAMAG NDA #208379 |
SUPPL-3 |
PITAVASTATIN MAGNESIUM |
MEDICURE |
Labeling |
Approval |
02/07/2020 |
CLOMIPRAMINE HYDROCHLORIDE ANDA #211364 |
ORIG-1 |
CLOMIPRAMINE HYDROCHLORIDE |
CHEMISTRY HLTH |
|
Approval |
02/07/2020 |
FULVESTRANT ANDA #211422 |
ORIG-1 |
FULVESTRANT |
CHIA TAI TIANQING |
|
Approval |
02/07/2020 |
DOXERCALCIFEROL ANDA #211670 |
ORIG-1 |
DOXERCALCIFEROL |
MEITHEAL |
|
Approval |
02/07/2020 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #211690 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
CEROVENE INC |
|
Approval |
02/08/2020 |
PEMFEXY NDA #209472 |
ORIG-1 |
PEMETREXED |
EAGLE PHARMS |
Type 5 - New Formulation or New Manufacturer |
Approval |
02/09/2020 |
RIZATRIPTAN BENZOATE ANDA #207835 |
SUPPL-3 |
RIZATRIPTAN BENZOATE |
UNICHEM |
Labeling |
Approval |
02/09/2020 |
TERIFLUNOMIDE ANDA #209572 |
SUPPL-1 |
TERIFLUNOMIDE |
ALEMBIC |
Labeling |
Approval |
02/10/2020 |
LOTREL NDA #020364 |
SUPPL-66 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
02/10/2020 |
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ANDA #062938 |
SUPPL-16 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
PADAGIS US |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #071849 |
SUPPL-13 |
MORPHINE SULFATE |
HOSPIRA |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #071850 |
SUPPL-14 |
MORPHINE SULFATE |
HOSPIRA |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #073509 |
SUPPL-19 |
MORPHINE SULFATE |
HOSPIRA |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #073510 |
SUPPL-20 |
MORPHINE SULFATE |
HOSPIRA |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #077267 |
SUPPL-17 |
ZIDOVUDINE |
AUROBINDO |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #077267 |
SUPPL-18 |
ZIDOVUDINE |
AUROBINDO |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #077267 |
SUPPL-19 |
ZIDOVUDINE |
AUROBINDO |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #077267 |
SUPPL-22 |
ZIDOVUDINE |
AUROBINDO |
Labeling |
Approval |
02/10/2020 |
STAVUDINE ANDA #077672 |
SUPPL-9 |
STAVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
02/10/2020 |
STAVUDINE ANDA #077672 |
SUPPL-10 |
STAVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
02/10/2020 |
STAVUDINE ANDA #078030 |
SUPPL-6 |
STAVUDINE |
CIPLA LTD |
Labeling |
Approval |
02/10/2020 |
STAVUDINE ANDA #078030 |
SUPPL-7 |
STAVUDINE |
CIPLA LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-7 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-8 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-9 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-10 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-11 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-12 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-13 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #079099 |
SUPPL-14 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #090092 |
SUPPL-6 |
ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #090092 |
SUPPL-8 |
ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
02/10/2020 |
ZIDOVUDINE ANDA #090092 |
SUPPL-9 |
ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
02/10/2020 |
ONTAK BLA #103767 |
SUPPL-5144 |
DENILEUKIN DIFTITOX |
EISAI INC |
|
Approval |
02/10/2020 |
PROLIA BLA #125320 |
SUPPL-201 |
DENOSUMAB |
AMGEN |
|
Approval |
02/10/2020 |
XGEVA BLA #125320 |
SUPPL-201 |
DENOSUMAB |
AMGEN |
|
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #201791 |
SUPPL-6 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/10/2020 |
LAMOTRIGINE ANDA #201791 |
SUPPL-7 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #202310 |
SUPPL-1 |
MORPHINE SULFATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #202310 |
SUPPL-3 |
MORPHINE SULFATE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-9 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-10 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-11 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-13 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-14 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-16 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-17 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-20 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
DIVALPROEX SODIUM ANDA #202419 |
SUPPL-21 |
DIVALPROEX SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/10/2020 |
ADEMPAS NDA #204819 |
SUPPL-14 |
RIOCIGUAT |
BAYER HLTHCARE |
REMS |
Approval |
02/10/2020 |
CYCLOPHOSPHAMIDE ANDA #207014 |
SUPPL-1 |
CYCLOPHOSPHAMIDE |
ANI PHARMS |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #208809 |
SUPPL-2 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
02/10/2020 |
MORPHINE SULFATE ANDA #208809 |
SUPPL-5 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
02/10/2020 |
FLUOCINONIDE ANDA #208989 |
ORIG-1 |
FLUOCINONIDE |
ZYDUS LIFESCIENCES |
|
Approval |
02/10/2020 |
FOSAPREPITANT DIMEGLUMINE ANDA #209965 |
SUPPL-1 |
FOSAPREPITANT DIMEGLUMINE |
MSN |
Manufacturing (CMC) |
Approval |
02/10/2020 |
SUCCINYLCHOLINE CHLORIDE ANDA #210231 |
SUPPL-2 |
SUCCINYLCHOLINE CHLORIDE |
AMRING PHARMS |
Labeling |
Approval |
02/10/2020 |
SUCCINYLCHOLINE CHLORIDE ANDA #210231 |
SUPPL-3 |
SUCCINYLCHOLINE CHLORIDE |
AMRING PHARMS |
Labeling |
Approval |
02/11/2020 |
FUSILEV NDA #020140 |
SUPPL-25 |
LEVOLEUCOVORIN CALCIUM |
ACROTECH BIOPHARMA |
Labeling |
Approval |
02/11/2020 |
ZINACEF NDA #050558 |
SUPPL-75 |
CEFUROXIME SODIUM |
PAI HOLDINGS PHARM |
Labeling |
Approval |
02/11/2020 |
FORTAZ NDA #050578 |
SUPPL-64 |
CEFTAZIDIME |
PAI HOLDINGS PHARM |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065264 |
SUPPL-21 |
CEFDINIR |
LUPIN |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065330 |
SUPPL-8 |
CEFDINIR |
SANDOZ |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065368 |
SUPPL-10 |
CEFDINIR |
TEVA PHARMS |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065368 |
SUPPL-11 |
CEFDINIR |
TEVA PHARMS |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065434 |
SUPPL-5 |
CEFDINIR |
AUROBINDO PHARMA |
Labeling |
Approval |
02/11/2020 |
CEFDINIR ANDA #065434 |
SUPPL-6 |
CEFDINIR |
AUROBINDO PHARMA |
Labeling |
Approval |
02/11/2020 |
CEFEPIME HYDROCHLORIDE ANDA #203704 |
SUPPL-7 |
CEFEPIME HYDROCHLORIDE |
QILU |
Labeling |
Approval |
02/11/2020 |
RIFAMPIN ANDA #204101 |
SUPPL-6 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
02/11/2020 |
RIFAMPIN ANDA #204101 |
SUPPL-7 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
02/11/2020 |
RIFAMPIN ANDA #204101 |
SUPPL-8 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
02/11/2020 |
SPRAVATO NDA #211243 |
SUPPL-3 |
ESKETAMINE HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
02/11/2020 |
DEFERASIROX ANDA #211852 |
ORIG-1 |
DEFERASIROX |
CIPLA |
|
Approval |
02/11/2020 |
CHLORTHALIDONE ANDA #213412 |
ORIG-1 |
CHLORTHALIDONE |
ALKEM LABS LTD |
|
Approval |
02/12/2020 |
FORTAZ NDA #050578 |
SUPPL-62 |
CEFTAZIDIME |
PAI HOLDINGS PHARM |
Labeling |
Approval |
02/12/2020 |
DORYX NDA #050795 |
SUPPL-28 |
DOXYCYCLINE HYCLATE |
MAYNE PHARMA |
Labeling |
Approval |
02/12/2020 |
DORYX MPC NDA #050795 |
SUPPL-28 |
DOXYCYCLINE HYCLATE |
MAYNE PHARMA |
Labeling |
Approval |
02/12/2020 |
ARCALYST BLA #125249 |
SUPPL-45 |
RILONACEPT |
KINIKSA PHARMACEUTICALS (UK), LTD. |
|
Approval |
02/12/2020 |
OXYCODONE HYDROCHLORIDE ANDA #202537 |
SUPPL-1 |
OXYCODONE HYDROCHLORIDE |
VISTAPHARM |
Labeling |
Approval |
02/12/2020 |
OXYCODONE HYDROCHLORIDE ANDA #202537 |
SUPPL-3 |
OXYCODONE HYDROCHLORIDE |
VISTAPHARM |
Labeling |
Approval |
02/12/2020 |
OXYCODONE HYDROCHLORIDE ANDA #202537 |
SUPPL-7 |
OXYCODONE HYDROCHLORIDE |
VISTAPHARM |
Labeling |
Approval |
02/12/2020 |
OXYCODONE HYDROCHLORIDE ANDA #204092 |
SUPPL-5 |
OXYCODONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
02/12/2020 |
OXYCODONE HYDROCHLORIDE ANDA #204092 |
SUPPL-7 |
OXYCODONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
02/12/2020 |
LAMOTRIGINE ANDA #204158 |
SUPPL-2 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/12/2020 |
LAMOTRIGINE ANDA #204158 |
SUPPL-3 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/12/2020 |
LAMOTRIGINE ANDA #204158 |
SUPPL-4 |
LAMOTRIGINE |
ENDO OPERATIONS |
Labeling |
Approval |
02/12/2020 |
KETOROLAC; PHENYLEPHRINE ANDA #208417 |
ORIG-1 |
KETOROLAC;PHENYLEPHRINE |
PAR STERILE PRODUCTS |
|
Tentative Approval |
02/12/2020 |
MESALAMINE ANDA #208953 |
ORIG-1 |
MESALAMINE |
ZYDUS PHARMS |
|
Approval |
02/12/2020 |
CLINDAMYCIN PHOSPHATE ANDA #209846 |
SUPPL-3 |
CLINDAMYCIN PHOSPHATE |
CHARTWELL RX |
Labeling |
Approval |
02/12/2020 |
CLINDAMYCIN PHOSPHATE ANDA #209846 |
SUPPL-4 |
CLINDAMYCIN PHOSPHATE |
CHARTWELL RX |
Labeling |
Approval |
02/12/2020 |
CLINDAMYCIN PHOSPHATE ANDA #209914 |
SUPPL-1 |
CLINDAMYCIN PHOSPHATE |
ENCUBE ETHICALS |
Labeling |
Approval |
02/12/2020 |
CLINDAMYCIN PHOSPHATE ANDA #209914 |
SUPPL-2 |
CLINDAMYCIN PHOSPHATE |
ENCUBE ETHICALS |
Labeling |
Approval |
02/12/2020 |
ALIQOPA NDA #209936 |
SUPPL-4 |
COPANLISIB DIHYDROCHLORIDE |
BAYER HEALTHCARE |
Labeling |
Approval |
02/12/2020 |
PIZENSY NDA #211281 |
ORIG-1 |
LACTITOL |
BRAINTREE LABS |
Type 1 - New Molecular Entity |
Approval |
02/12/2020 |
RANOLAZINE ANDA #212284 |
ORIG-1 |
RANOLAZINE |
MANKIND PHARMA |
|
Approval |
02/12/2020 |
URSODIOL ANDA #213200 |
ORIG-1 |
URSODIOL |
RISING |
|
Approval |
02/12/2020 |
UDENYCA BLA #761039 |
SUPPL-3 |
PEGFILGRASTIM-CBQV |
COHERUS BIOSCIENCES INC |
|
Approval |
02/13/2020 |
DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER NDA #017484 |
SUPPL-76 |
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
02/13/2020 |
AFINITOR NDA #022334 |
SUPPL-44 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
02/13/2020 |
CEFTAZIDIME ANDA #062640 |
SUPPL-40 |
CEFTAZIDIME |
ACS DOBFAR |
Labeling |
Approval |
02/13/2020 |
CEFTAZIDIME ANDA #062640 |
SUPPL-42 |
CEFTAZIDIME |
ACS DOBFAR |
Labeling |
Approval |
02/13/2020 |
PICATO NDA #202833 |
SUPPL-11 |
INGENOL MEBUTATE |
LEO LABS |
Labeling |
Approval |
02/13/2020 |
STIVARGA NDA #203085 |
SUPPL-11 |
REGORAFENIB |
BAYER HLTHCARE |
Labeling |
Approval |
02/13/2020 |
AFINITOR DISPERZ NDA #203985 |
SUPPL-16 |
EVEROLIMUS |
NOVARTIS PHARM |
Labeling |
Approval |
02/13/2020 |
PENICILLAMINE ANDA #211497 |
ORIG-1 |
PENICILLAMINE |
TEVA PHARMS USA |
|
Approval |
02/14/2020 |
PATADAY TWICE DAILY RELIEF NDA #020688 |
SUPPL-32 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Efficacy |
Approval |
02/14/2020 |
PATADAY ONCE DAILY RELIEF NDA #021545 |
SUPPL-22 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Efficacy |
Approval |
02/14/2020 |
VOLTAREN ARTHRITIS PAIN NDA #022122 |
SUPPL-14 |
DICLOFENAC SODIUM |
HALEON US HOLDINGS |
Efficacy |
Approval |
02/14/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE ANDA #040888 |
SUPPL-1 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
SAGENT PHARMS INC |
Labeling |
Approval |
02/14/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE ANDA #040888 |
SUPPL-3 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
SAGENT PHARMS INC |
Labeling |
Approval |
02/14/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE ANDA #040888 |
SUPPL-4 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
SAGENT PHARMS INC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #076832 |
SUPPL-11 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #076832 |
SUPPL-12 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #076832 |
SUPPL-13 |
LITHIUM CARBONATE |
HIKMA |
Labeling |
Approval |
02/14/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077162 |
SUPPL-7 |
SERTRALINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/14/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077162 |
SUPPL-8 |
SERTRALINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/14/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077162 |
SUPPL-9 |
SERTRALINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/14/2020 |
CETIRIZINE HYDROCHLORIDE ANDA #078496 |
SUPPL-6 |
CETIRIZINE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #202288 |
SUPPL-3 |
LITHIUM CARBONATE |
MYLAN PHARMS INC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #202288 |
SUPPL-4 |
LITHIUM CARBONATE |
MYLAN PHARMS INC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #202288 |
SUPPL-5 |
LITHIUM CARBONATE |
MYLAN PHARMS INC |
Labeling |
Approval |
02/14/2020 |
DICLOFENAC SODIUM ANDA #202852 |
SUPPL-2 |
DICLOFENAC SODIUM |
WATSON LABS INC |
Labeling |
Approval |
02/14/2020 |
TWIRLA NDA #204017 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AGILE |
Type 3 - New Dosage Form |
Approval |
02/14/2020 |
DICLOFENAC SODIUM ANDA #204132 |
SUPPL-2 |
DICLOFENAC SODIUM |
LUPIN LTD |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204445 |
SUPPL-1 |
LITHIUM CARBONATE |
ALEMBIC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204445 |
SUPPL-3 |
LITHIUM CARBONATE |
ALEMBIC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204445 |
SUPPL-5 |
LITHIUM CARBONATE |
ALEMBIC |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204779 |
SUPPL-2 |
LITHIUM CARBONATE |
UNIQUE |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204779 |
SUPPL-3 |
LITHIUM CARBONATE |
UNIQUE |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #204779 |
SUPPL-4 |
LITHIUM CARBONATE |
UNIQUE |
Labeling |
Approval |
02/14/2020 |
SILODOSIN ANDA #204793 |
ORIG-1 |
SILODOSIN |
HETERO LABS LTD V |
|
Approval |
02/14/2020 |
QUDEXY XR NDA #205122 |
SUPPL-10 |
TOPIRAMATE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #205532 |
SUPPL-1 |
LITHIUM CARBONATE |
HERITAGE PHARMA |
Labeling |
Approval |
02/14/2020 |
LITHIUM CARBONATE ANDA #205532 |
SUPPL-3 |
LITHIUM CARBONATE |
HERITAGE PHARMA |
Labeling |
Approval |
02/14/2020 |
DICLOFENAC SODIUM ANDA #205878 |
SUPPL-1 |
DICLOFENAC SODIUM |
NOVEL LABS INC |
Labeling |
Approval |
02/14/2020 |
AMBRISENTAN ANDA #210058 |
SUPPL-4 |
AMBRISENTAN |
ZYDUS PHARMS |
Labeling |
Approval |
02/14/2020 |
DESMOPRESSIN ACETATE ANDA #210218 |
ORIG-1 |
DESMOPRESSIN ACETATE |
UBI |
|
Approval |
02/14/2020 |
AMBRISENTAN ANDA #210715 |
SUPPL-3 |
AMBRISENTAN |
CIPLA |
Labeling |
Approval |
02/14/2020 |
PROCYSBI NDA #213491 |
ORIG-1 |
CYSTEAMINE BITARTRATE |
HORIZON |
Type 3 - New Dosage Form |
Approval |
02/15/2020 |
AIMOVIG BLA #761077 |
SUPPL-4 |
ERENUMAB-AOOE |
AMGEN INC |
|
Approval |
02/18/2020 |
KETOCONAZOLE ANDA #074971 |
SUPPL-3 |
KETOCONAZOLE |
CHARTWELL RX |
Labeling |
Approval |
02/18/2020 |
KETOCONAZOLE ANDA #076942 |
SUPPL-24 |
KETOCONAZOLE |
COSETTE |
Labeling |
Approval |
02/18/2020 |
MYOZYME BLA #125141 |
SUPPL-223 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
02/18/2020 |
LUMIZYME BLA #125291 |
SUPPL-151 |
ALGLUCOSIDASE ALFA |
GENZYME |
|
Approval |
02/18/2020 |
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM ANDA #204206 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
DR REDDYS |
|
Approval |
02/18/2020 |
MELPHALAN HYDROCHLORIDE ANDA #210947 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
INGENUS PHARMS LLC |
|
Approval |
02/18/2020 |
MONTELUKAST SODIUM ANDA #213471 |
ORIG-1 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
|
Approval |
02/19/2020 |
BACTROBAN NDA #050703 |
SUPPL-18 |
MUPIROCIN CALCIUM |
GLAXOSMITHKLINE |
Labeling |
Approval |
02/19/2020 |
BACTROBAN NDA #050746 |
SUPPL-22 |
MUPIROCIN CALCIUM |
GLAXOSMITHKLINE |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #091449 |
SUPPL-6 |
LATANOPROST |
SANDOZ |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #201786 |
SUPPL-2 |
LATANOPROST |
SOMERSET |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #201786 |
SUPPL-3 |
LATANOPROST |
SOMERSET |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #202442 |
SUPPL-2 |
LATANOPROST |
FDC LTD |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #202442 |
SUPPL-6 |
LATANOPROST |
FDC LTD |
Labeling |
Approval |
02/19/2020 |
LATANOPROST ANDA #202442 |
SUPPL-7 |
LATANOPROST |
FDC LTD |
Labeling |
Approval |
02/19/2020 |
INJECTAFER NDA #203565 |
SUPPL-9 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Labeling |
Approval |
02/19/2020 |
SILDENAFIL CITRATE ANDA #204883 |
SUPPL-1 |
SILDENAFIL CITRATE |
RUBICON |
Labeling |
Approval |
02/19/2020 |
SILDENAFIL CITRATE ANDA #204883 |
SUPPL-3 |
SILDENAFIL CITRATE |
RUBICON |
Labeling |
Approval |
02/19/2020 |
SILDENAFIL CITRATE ANDA #204883 |
SUPPL-4 |
SILDENAFIL CITRATE |
RUBICON |
Labeling |
Approval |
02/19/2020 |
SILDENAFIL CITRATE ANDA #204883 |
SUPPL-5 |
SILDENAFIL CITRATE |
RUBICON |
Labeling |
Approval |
02/19/2020 |
DICLOFENAC SODIUM AND MISOPROSTOL ANDA #205143 |
ORIG-1 |
DICLOFENAC SODIUM; MISOPROSTOL |
YUNG SHIN PHARM |
|
Approval |
02/19/2020 |
DOCETAXEL NDA #205934 |
SUPPL-3 |
DOCETAXEL |
SHILPA |
Labeling |
Approval |
02/19/2020 |
OLOPATADINE HYDROCHLORIDE ANDA #208637 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
FLORIDA |
|
Approval |
02/19/2020 |
ZOLEDRONIC ACID ANDA #208968 |
ORIG-1 |
ZOLEDRONIC ACID |
NOVAST LABS |
|
Approval |
02/19/2020 |
ETHACRYNIC ACID ANDA #212417 |
ORIG-1 |
ETHACRYNIC ACID |
UPSHER SMITH LABS |
|
Approval |
02/20/2020 |
METOPIRONE NDA #012911 |
SUPPL-36 |
METYRAPONE |
HRA PHARMA |
Labeling |
Approval |
02/20/2020 |
FERRIPROX NDA #021825 |
SUPPL-7 |
DEFERIPRONE |
CHIESI |
Labeling |
Approval |
02/20/2020 |
VIBATIV NDA #022110 |
SUPPL-15 |
TELAVANCIN HYDROCHLORIDE |
CUMBERLAND |
Labeling |
Approval |
02/20/2020 |
AMPICILLIN SODIUM ANDA #062738 |
SUPPL-24 |
AMPICILLIN SODIUM |
SANDOZ |
Labeling |
Approval |
02/20/2020 |
LIDOCAINE HYDROCHLORIDE ANDA #080407 |
SUPPL-98 |
LIDOCAINE HYDROCHLORIDE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
02/20/2020 |
LIDOCAINE HYDROCHLORIDE ANDA #080407 |
SUPPL-99 |
LIDOCAINE HYDROCHLORIDE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
02/20/2020 |
ISOSORBIDE DINITRATE ANDA #086221 |
SUPPL-51 |
ISOSORBIDE DINITRATE |
SANDOZ |
Labeling |
Approval |
02/20/2020 |
ISOSORBIDE DINITRATE ANDA #086223 |
SUPPL-50 |
ISOSORBIDE DINITRATE |
SANDOZ |
Labeling |
Approval |
02/20/2020 |
ISOSORBIDE DINITRATE ANDA #089367 |
SUPPL-23 |
ISOSORBIDE DINITRATE |
SANDOZ |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-13 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-14 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-15 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-16 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-17 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-18 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
DIVALPROEX SODIUM ANDA #090070 |
SUPPL-19 |
DIVALPROEX SODIUM |
REDDYS |
Labeling |
Approval |
02/20/2020 |
CYRAMZA BLA #125477 |
SUPPL-36 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
02/20/2020 |
ARIPIPRAZOLE ANDA #206383 |
SUPPL-1 |
ARIPIPRAZOLE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
02/20/2020 |
LENVIMA NDA #206947 |
SUPPL-12 |
LENVATINIB MESYLATE |
EISAI INC |
Labeling |
Approval |
02/20/2020 |
TOBRAMYCIN ANDA #207080 |
SUPPL-6 |
TOBRAMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
02/20/2020 |
FERRIPROX NDA #208030 |
SUPPL-4 |
DEFERIPRONE |
CHIESI |
Labeling |
Approval |
02/20/2020 |
ANJESO NDA #210583 |
ORIG-1 |
MELOXICAM |
BAUDAX |
Type 3 - New Dosage Form |
Approval |
02/20/2020 |
TRIENTINE HYDROCHLORIDE ANDA #212238 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
RISING PHARMA |
|
Approval |
02/20/2020 |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ANDA #213413 |
ORIG-1 |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
LEADING |
|
Approval |
02/21/2020 |
RAZADYNE NDA #021169 |
SUPPL-33 |
GALANTAMINE HYDROBROMIDE |
JANSSEN PHARMS |
Labeling |
Approval |
02/21/2020 |
RAZADYNE ER NDA #021615 |
SUPPL-24 |
GALANTAMINE HYDROBROMIDE |
JANSSEN PHARMS |
Labeling |
Approval |
02/21/2020 |
LIDOCAINE HYDROCHLORIDE ANDA #040710 |
SUPPL-8 |
LIDOCAINE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
02/21/2020 |
KALEXATE ANDA #040905 |
SUPPL-6 |
SODIUM POLYSTYRENE SULFONATE |
KVK TECH |
Labeling |
Approval |
02/21/2020 |
ACANYA NDA #050819 |
SUPPL-23 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
BAUSCH |
Labeling |
Approval |
02/21/2020 |
ACANYA NDA #050819 |
SUPPL-24 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
BAUSCH |
Labeling |
Approval |
02/21/2020 |
ONEXTON NDA #050819 |
SUPPL-23 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
BAUSCH |
Labeling |
Approval |
02/21/2020 |
ONEXTON NDA #050819 |
SUPPL-24 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
BAUSCH |
Labeling |
Approval |
02/21/2020 |
NORTRIPTYLINE HYDROCHLORIDE ANDA #073556 |
SUPPL-55 |
NORTRIPTYLINE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
02/21/2020 |
CIMETIDINE ANDA #075285 |
SUPPL-44 |
CIMETIDINE |
L PERRIGO CO |
Labeling |
Approval |
02/21/2020 |
VALPROIC ACID ANDA #075379 |
SUPPL-11 |
VALPROIC ACID |
PHARM ASSOC |
Labeling |
Approval |
02/21/2020 |
VALPROIC ACID ANDA #075379 |
SUPPL-13 |
VALPROIC ACID |
PHARM ASSOC |
Labeling |
Approval |
02/21/2020 |
VALPROIC ACID ANDA #075379 |
SUPPL-16 |
VALPROIC ACID |
PHARM ASSOC |
Labeling |
Approval |
02/21/2020 |
VALPROIC ACID ANDA #075379 |
SUPPL-17 |
VALPROIC ACID |
PHARM ASSOC |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #076465 |
SUPPL-19 |
SERTRALINE HYDROCHLORIDE |
HERITAGE PHARMA AVET |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #076882 |
SUPPL-17 |
SERTRALINE HYDROCHLORIDE |
VIWIT PHARM |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #076882 |
SUPPL-18 |
SERTRALINE HYDROCHLORIDE |
VIWIT PHARM |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #076882 |
SUPPL-19 |
SERTRALINE HYDROCHLORIDE |
VIWIT PHARM |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077106 |
SUPPL-6 |
SERTRALINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077106 |
SUPPL-7 |
SERTRALINE HYDROCHLORIDE |
ZYDUS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077206 |
SUPPL-29 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077206 |
SUPPL-30 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077206 |
SUPPL-31 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077299 |
SUPPL-4 |
SERTRALINE HYDROCHLORIDE |
HERITAGE PHARMA AVET |
Labeling |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #077375 |
SUPPL-11 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077397 |
SUPPL-19 |
SERTRALINE HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077397 |
SUPPL-26 |
SERTRALINE HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077663 |
SUPPL-7 |
SERTRALINE HYDROCHLORIDE |
HERITAGE PHARMA AVET |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077670 |
SUPPL-27 |
SERTRALINE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077670 |
SUPPL-29 |
SERTRALINE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077670 |
SUPPL-31 |
SERTRALINE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077713 |
SUPPL-6 |
SERTRALINE HYDROCHLORIDE |
APPCO |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077765 |
SUPPL-17 |
SERTRALINE HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077864 |
SUPPL-2 |
SERTRALINE HYDROCHLORIDE |
HIKMA PHARMS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077977 |
SUPPL-13 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077977 |
SUPPL-14 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #077977 |
SUPPL-15 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
02/21/2020 |
ROPINIROLE HYDROCHLORIDE ANDA #078110 |
SUPPL-12 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
02/21/2020 |
ROPINIROLE HYDROCHLORIDE ANDA #078110 |
SUPPL-14 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
02/21/2020 |
ROPINIROLE HYDROCHLORIDE ANDA #078110 |
SUPPL-17 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
02/21/2020 |
BUSPIRONE HYDROCHLORIDE ANDA #078246 |
SUPPL-2 |
BUSPIRONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Manufacturing (CMC) |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #078466 |
SUPPL-20 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE ANDA #078466 |
SUPPL-20 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #078626 |
SUPPL-13 |
SERTRALINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #078626 |
SUPPL-14 |
SERTRALINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/21/2020 |
SERTRALINE HYDROCHLORIDE ANDA #078626 |
SUPPL-15 |
SERTRALINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #079047 |
SUPPL-10 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-11 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-14 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-15 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-16 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-17 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-18 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
DIVALPROEX SODIUM ANDA #090161 |
SUPPL-19 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #091170 |
SUPPL-6 |
ZOLEDRONIC ACID |
BRECKENRIDGE |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #091170 |
SUPPL-7 |
ZOLEDRONIC ACID |
BRECKENRIDGE |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #091186 |
SUPPL-10 |
ZOLEDRONIC ACID |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #091186 |
SUPPL-11 |
ZOLEDRONIC ACID |
DR REDDYS LABS LTD |
Labeling |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #091431 |
SUPPL-3 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
02/21/2020 |
HALOPERIDOL ANDA #091637 |
SUPPL-7 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
02/21/2020 |
TRULICITY BLA #125469 |
SUPPL-33 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
02/21/2020 |
HALOPERIDOL ANDA #200742 |
SUPPL-5 |
HALOPERIDOL LACTATE |
SAGENT PHARMS |
Labeling |
Approval |
02/21/2020 |
LATANOPROST ANDA #201006 |
SUPPL-8 |
LATANOPROST |
BAUSCH AND LOMB |
Labeling |
Approval |
02/21/2020 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #202001 |
SUPPL-10 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TORRENT PHARMS LTD |
Labeling |
Approval |
02/21/2020 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #202001 |
SUPPL-11 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TORRENT PHARMS LTD |
Labeling |
Approval |
02/21/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #202239 |
SUPPL-10 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/21/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #202289 |
SUPPL-18 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
02/21/2020 |
REVATIO NDA #203109 |
SUPPL-15 |
SILDENAFIL CITRATE |
VIATRIS |
Labeling |
Approval |
02/21/2020 |
MEGESTROL ACETATE ANDA #203139 |
SUPPL-14 |
MEGESTROL ACETATE |
TWI PHARMS |
Labeling |
Approval |
02/21/2020 |
SILDENAFIL CITRATE ANDA #203963 |
SUPPL-2 |
SILDENAFIL CITRATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/21/2020 |
SILDENAFIL CITRATE ANDA #203963 |
SUPPL-3 |
SILDENAFIL CITRATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/21/2020 |
SILDENAFIL CITRATE ANDA #203963 |
SUPPL-4 |
SILDENAFIL CITRATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
02/21/2020 |
SODIUM POLYSTYRENE SULFONATE ANDA #204071 |
SUPPL-3 |
SODIUM POLYSTYRENE SULFONATE |
NUVO PHARMS INC |
Labeling |
Approval |
02/21/2020 |
VASOSTRICT NDA #204485 |
SUPPL-14 |
VASOPRESSIN |
ENDO OPERATIONS |
Labeling |
Approval |
02/21/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #204832 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
UNICHEM |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #205279 |
SUPPL-1 |
ZOLEDRONIC ACID |
ACCORD HLTHCARE |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #205279 |
SUPPL-6 |
ZOLEDRONIC ACID |
ACCORD HLTHCARE |
Labeling |
Approval |
02/21/2020 |
TOBRAMYCIN ANDA #205501 |
SUPPL-5 |
TOBRAMYCIN |
AMNEAL PHARMS |
Labeling |
Approval |
02/21/2020 |
SODIUM POLYSTYRENE SULFONATE ANDA #206815 |
SUPPL-1 |
SODIUM POLYSTYRENE SULFONATE |
CHARTWELL RX |
Labeling |
Approval |
02/21/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE ANDA #207549 |
SUPPL-3 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
AMNEAL |
Labeling |
Approval |
02/21/2020 |
METHYLPREDNISOLONE SODIUM SUCCINATE ANDA #207549 |
SUPPL-4 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
AMNEAL |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #207751 |
SUPPL-1 |
ZOLEDRONIC ACID |
EUGIA PHARMA |
Labeling |
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #207751 |
SUPPL-2 |
ZOLEDRONIC ACID |
EUGIA PHARMA |
Labeling |
Approval |
02/21/2020 |
NINLARO NDA #208462 |
SUPPL-6 |
IXAZOMIB CITRATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
02/21/2020 |
AIRDUO DIGIHALER NDA #208799 |
SUPPL-11 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
02/21/2020 |
AIRDUO RESPICLICK NDA #208799 |
SUPPL-11 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
02/21/2020 |
ROSUVASTATIN CALCIUM ANDA #208898 |
SUPPL-3 |
ROSUVASTATIN CALCIUM |
MSN |
Labeling |
Approval |
02/21/2020 |
TADALAFIL ANDA #210069 |
SUPPL-2 |
TADALAFIL |
DR REDDYS |
Manufacturing (CMC) |
Approval |
02/21/2020 |
GLYCOPYRROLATE ANDA #210083 |
ORIG-1 |
GLYCOPYRROLATE |
SAGENT |
|
Approval |
02/21/2020 |
ZOLEDRONIC ACID ANDA #210174 |
SUPPL-1 |
ZOLEDRONIC ACID |
AMNEAL |
Labeling |
Approval |
02/21/2020 |
CALCIUM ACETATE ANDA #211038 |
ORIG-1 |
CALCIUM ACETATE |
SUVEN PHARMS |
|
Approval |
02/21/2020 |
NEXLETOL NDA #211616 |
ORIG-1 |
BEMPEDOIC ACID |
ESPERION THERAPS INC |
Type 1 - New Molecular Entity |
Approval |
02/21/2020 |
NAPROXEN ANDA #212517 |
ORIG-1 |
NAPROXEN |
SCIEGEN PHARMS INC |
|
Approval |
02/21/2020 |
NICOTINE POLACRILEX ANDA #212983 |
ORIG-1 |
NICOTINE POLACRILEX |
DR REDDYS LABS SA |
|
Approval |
02/21/2020 |
VYEPTI BLA #761119 |
ORIG-1 |
EPTINEZUMAB-JJMR |
Lundbeck Seattle BioPharmaceuticals, Inc. |
|
Approval |
02/24/2020 |
FIRMAGON NDA #022201 |
SUPPL-16 |
DEGARELIX ACETATE |
FERRING |
Labeling |
Approval |
02/24/2020 |
MIRTAZAPINE ANDA #076119 |
SUPPL-26 |
MIRTAZAPINE |
TEVA |
Labeling |
Approval |
02/24/2020 |
MIRTAZAPINE ANDA #076119 |
SUPPL-27 |
MIRTAZAPINE |
TEVA |
Labeling |
Approval |
02/24/2020 |
MIRTAZAPINE ANDA #076119 |
SUPPL-30 |
MIRTAZAPINE |
TEVA |
Labeling |
Approval |
02/24/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #078385 |
SUPPL-18 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
02/24/2020 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #091273 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
02/24/2020 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #091273 |
SUPPL-10 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
02/24/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #091617 |
SUPPL-21 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
02/24/2020 |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE ANDA #201049 |
SUPPL-7 |
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
02/24/2020 |
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE ANDA #201049 |
SUPPL-8 |
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
02/24/2020 |
TOLTERODINE TARTRATE ANDA #201486 |
SUPPL-7 |
TOLTERODINE TARTRATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
02/24/2020 |
MORPHINE SULFATE ANDA #202348 |
SUPPL-5 |
MORPHINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
02/24/2020 |
MORPHINE SULFATE ANDA #202348 |
SUPPL-7 |
MORPHINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
02/24/2020 |
MORPHINE SULFATE ANDA #202348 |
SUPPL-8 |
MORPHINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
02/24/2020 |
ALBUTEROL SULFATE ANDA #203760 |
ORIG-1 |
ALBUTEROL SULFATE |
PADAGIS US |
|
Approval |
02/24/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE ANDA #204228 |
SUPPL-1 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
02/24/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE ANDA #204228 |
SUPPL-6 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
02/24/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE ANDA #204228 |
SUPPL-9 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
02/24/2020 |
MEGESTROL ACETATE ANDA #204688 |
SUPPL-2 |
MEGESTROL ACETATE |
CHARTWELL |
Labeling |
Approval |
02/24/2020 |
OMEGA-3-ACID ETHYL ESTERS ANDA #204940 |
SUPPL-7 |
OMEGA-3-ACID ETHYL ESTERS |
AMNEAL PHARMS |
Labeling |
Approval |
02/24/2020 |
ABACAVIR SULFATE AND LAMIVUDINE ANDA #204990 |
SUPPL-4 |
ABACAVIR SULFATE; LAMIVUDINE |
CHARTWELL RX |
Labeling |
Approval |
02/24/2020 |
ABACAVIR SULFATE AND LAMIVUDINE ANDA #204990 |
SUPPL-6 |
ABACAVIR SULFATE; LAMIVUDINE |
CHARTWELL RX |
Labeling |
Approval |
02/24/2020 |
ABACAVIR SULFATE AND LAMIVUDINE ANDA #204990 |
SUPPL-7 |
ABACAVIR SULFATE; LAMIVUDINE |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
02/24/2020 |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE ANDA #205811 |
SUPPL-2 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
02/24/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE ANDA #207476 |
SUPPL-1 |
OMEPRAZOLE; SODIUM BICARBONATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
02/24/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE ANDA #207476 |
SUPPL-5 |
OMEPRAZOLE; SODIUM BICARBONATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
02/24/2020 |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE ANDA #208518 |
SUPPL-1 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
02/24/2020 |
CLOBAZAM ANDA #209796 |
ORIG-1 |
CLOBAZAM |
HETERO LABS LTD III |
|
Approval |
02/24/2020 |
RANOLAZINE ANDA #210054 |
SUPPL-8 |
RANOLAZINE |
AJANTA PHARMA LTD |
Labeling |
Approval |
02/24/2020 |
ALBENDAZOLE ANDA #210434 |
SUPPL-1 |
ALBENDAZOLE |
CIPLA LTD |
Labeling |
Approval |
02/24/2020 |
AKYNZEO NDA #210493 |
SUPPL-1 |
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE |
HELSINN HLTHCARE |
Manufacturing (CMC) |
Approval |
02/24/2020 |
HEPARIN SODIUM ANDA #211004 |
ORIG-1 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
02/24/2020 |
FEXOFENADINE HYDROCHLORIDE ANDA #212971 |
ORIG-1 |
FEXOFENADINE HYDROCHLORIDE |
L PERRIGO CO |
|
Approval |
02/25/2020 |
STRATTERA NDA #021411 |
SUPPL-49 |
ATOMOXETINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
02/25/2020 |
DACOGEN NDA #021790 |
SUPPL-23 |
DECITABINE |
OTSUKA |
Labeling |
Approval |
02/25/2020 |
DOCEFREZ NDA #022534 |
SUPPL-11 |
DOCETAXEL |
SUN PHARM |
Labeling |
Approval |
02/25/2020 |
DOCETAXEL NDA #022534 |
SUPPL-11 |
DOCETAXEL |
SUN PHARM |
Labeling |
Approval |
02/25/2020 |
MIRTAZAPINE ANDA #076219 |
SUPPL-24 |
MIRTAZAPINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
MIRTAZAPINE ANDA #076219 |
SUPPL-25 |
MIRTAZAPINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
MIRTAZAPINE ANDA #076307 |
SUPPL-20 |
MIRTAZAPINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
02/25/2020 |
MIRTAZAPINE ANDA #076307 |
SUPPL-22 |
MIRTAZAPINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
02/25/2020 |
SILDENAFIL CITRATE ANDA #078380 |
SUPPL-6 |
SILDENAFIL CITRATE |
TEVA PHARMS |
Labeling |
Approval |
02/25/2020 |
SILDENAFIL CITRATE ANDA #078380 |
SUPPL-7 |
SILDENAFIL CITRATE |
TEVA PHARMS |
Labeling |
Approval |
02/25/2020 |
SILDENAFIL CITRATE ANDA #078380 |
SUPPL-9 |
SILDENAFIL CITRATE |
TEVA PHARMS |
Labeling |
Approval |
02/25/2020 |
SODIUM POLYSTYRENE SULFONATE ANDA #090313 |
SUPPL-2 |
SODIUM POLYSTYRENE SULFONATE |
UPSHER SMITH LABS |
Labeling |
Approval |
02/25/2020 |
RANOLAZINE ANDA #201046 |
SUPPL-1 |
RANOLAZINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
RANOLAZINE ANDA #201046 |
SUPPL-2 |
RANOLAZINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
RANOLAZINE ANDA #201046 |
SUPPL-4 |
RANOLAZINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
RANOLAZINE ANDA #201046 |
SUPPL-7 |
RANOLAZINE |
CHARTWELL RX |
Labeling |
Approval |
02/25/2020 |
SODIUM POLYSTYRENE SULFONATE ANDA #202333 |
SUPPL-1 |
SODIUM POLYSTYRENE SULFONATE |
EPIC PHARMA LLC |
Labeling |
Approval |
02/25/2020 |
CELECOXIB ANDA #207872 |
ORIG-1 |
CELECOXIB |
TIANJIN TIANYAO |
|
Approval |
02/25/2020 |
NERLYNX NDA #208051 |
SUPPL-5 |
NERATINIB MALEATE |
PUMA BIOTECH |
Efficacy |
Approval |
02/25/2020 |
NERLYNX NDA #208051 |
SUPPL-6 |
NERATINIB MALEATE |
PUMA BIOTECH |
Efficacy |
Approval |
02/25/2020 |
AZELASTINE HYDROCHLORIDE ANDA #210092 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
GLAND PHARMA LTD |
|
Approval |
02/26/2020 |
ZEJULA NDA #208447 |
SUPPL-12 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
02/26/2020 |
BARHEMSYS NDA #209510 |
ORIG-1 |
AMISULPRIDE |
ACACIA |
Type 1 - New Molecular Entity |
Approval |
02/26/2020 |
NEXLIZET NDA #211617 |
ORIG-1 |
BEMPEDOIC ACID; EZETIMIBE |
ESPERION THERAPS INC |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
02/26/2020 |
AMINOCAPROIC ACID ANDA #212814 |
ORIG-1 |
AMINOCAPROIC ACID |
VISTAPHARM LLC |
|
Approval |
02/27/2020 |
EXCEDRIN (MIGRAINE RELIEF) NDA #020802 |
SUPPL-34 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
HALEON US HOLDINGS |
Labeling |
Approval |
02/27/2020 |
NAPROXEN SODIUM NDA #021920 |
SUPPL-27 |
NAPROXEN SODIUM |
BIONPHARMA |
Labeling |
Approval |
02/27/2020 |
EPITOL ANDA #070541 |
SUPPL-60 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
02/27/2020 |
EPITOL ANDA #070541 |
SUPPL-64 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
02/27/2020 |
EPITOL ANDA #073524 |
SUPPL-45 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
02/27/2020 |
EPITOL ANDA #073524 |
SUPPL-48 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
02/27/2020 |
CHLORHEXIDINE GLUCONATE ANDA #074356 |
SUPPL-12 |
CHLORHEXIDINE GLUCONATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
02/27/2020 |
ASPIRIN AND DIPYRIDAMOLE ANDA #078804 |
SUPPL-6 |
ASPIRIN; DIPYRIDAMOLE |
BARR |
Labeling |
Approval |
02/27/2020 |
ASPIRIN AND DIPYRIDAMOLE ANDA #078804 |
SUPPL-7 |
ASPIRIN; DIPYRIDAMOLE |
BARR |
Labeling |
Approval |
02/27/2020 |
RANOLAZINE ANDA #211745 |
ORIG-1 |
RANOLAZINE |
MICRO LABS |
|
Approval |
02/27/2020 |
NURTEC ODT NDA #212728 |
ORIG-1 |
RIMEGEPANT SULFATE |
PFIZER |
Type 1 - New Molecular Entity |
Approval |
02/27/2020 |
MYLOTARG BLA #761060 |
SUPPL-3 |
GEMTUZUMAB OZOGAMICIN |
WYETH PHARMS INC |
|
Approval |
02/28/2020 |
AGRYLIN NDA #020333 |
SUPPL-26 |
ANAGRELIDE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
02/28/2020 |
BYETTA NDA #021773 |
SUPPL-43 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
02/28/2020 |
BYDUREON NDA #022200 |
SUPPL-30 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
02/28/2020 |
BYDUREON PEN NDA #022200 |
SUPPL-30 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
02/28/2020 |
LIDOCAINE HYDROCHLORIDE ANDA #040078 |
SUPPL-22 |
LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
02/28/2020 |
LIDOCAINE HYDROCHLORIDE ANDA #040078 |
SUPPL-24 |
LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
02/28/2020 |
VERAPAMIL HYDROCHLORIDE ANDA #071489 |
SUPPL-23 |
VERAPAMIL HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
02/28/2020 |
VERAPAMIL HYDROCHLORIDE ANDA #071489 |
SUPPL-24 |
VERAPAMIL HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
02/28/2020 |
CARBAMAZEPINE ANDA #074649 |
SUPPL-34 |
CARBAMAZEPINE |
TARO |
Labeling |
Approval |
02/28/2020 |
KETOCONAZOLE ANDA #075273 |
SUPPL-18 |
KETOCONAZOLE |
TEVA |
Labeling |
Approval |
02/28/2020 |
KETOCONAZOLE ANDA #075362 |
SUPPL-13 |
KETOCONAZOLE |
HERITAGE PHARMA |
Labeling |
Approval |
02/28/2020 |
CHLORHEXIDINE GLUCONATE ANDA #075561 |
SUPPL-8 |
CHLORHEXIDINE GLUCONATE |
BAJAJ |
Labeling |
Approval |
02/28/2020 |
CARBAMAZEPINE ANDA #075687 |
SUPPL-28 |
CARBAMAZEPINE |
TARO PHARM INDS |
Labeling |
Approval |
02/28/2020 |
VALACYCLOVIR HYDROCHLORIDE ANDA #076588 |
SUPPL-21 |
VALACYCLOVIR HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
02/28/2020 |
TERIL ANDA #076729 |
SUPPL-17 |
CARBAMAZEPINE |
TARO |
Labeling |
Approval |
02/28/2020 |
CARBAMAZEPINE ANDA #078115 |
SUPPL-19 |
CARBAMAZEPINE |
TARO |
Labeling |
Approval |
02/28/2020 |
TERBINAFINE HYDROCHLORIDE ANDA #078199 |
SUPPL-9 |
TERBINAFINE HYDROCHLORIDE |
CHARTWELL |
Labeling |
Approval |
02/28/2020 |
TERBINAFINE HYDROCHLORIDE ANDA #078199 |
SUPPL-10 |
TERBINAFINE HYDROCHLORIDE |
CHARTWELL |
Labeling |
Approval |
02/28/2020 |
TERBINAFINE HYDROCHLORIDE ANDA #078199 |
SUPPL-11 |
TERBINAFINE HYDROCHLORIDE |
CHARTWELL |
Labeling |
Approval |
02/28/2020 |
GEMCITABINE HYDROCHLORIDE ANDA #079160 |
SUPPL-11 |
GEMCITABINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
02/28/2020 |
GEMCITABINE HYDROCHLORIDE ANDA #200145 |
SUPPL-12 |
GEMCITABINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
02/28/2020 |
OXYBUTYNIN CHLORIDE ANDA #202332 |
SUPPL-4 |
OXYBUTYNIN CHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
02/28/2020 |
AUBAGIO NDA #202992 |
SUPPL-10 |
TERIFLUNOMIDE |
SANOFI AVENTIS US |
Labeling |
Approval |
02/28/2020 |
VELPHORO NDA #205109 |
SUPPL-8 |
FERRIC OXYHYDROXIDE |
VIFOR FRESENIUS |
Labeling |
Approval |
02/28/2020 |
GEMCITABINE HYDROCHLORIDE ANDA #205242 |
SUPPL-4 |
GEMCITABINE HYDROCHLORIDE |
MYLAN LABS LTD |
Labeling |
Approval |
02/28/2020 |
MEMANTINE HYDROCHLORIDE ANDA #205365 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
ANI PHARMS |
|
Approval |
02/28/2020 |
LITHIUM CARBONATE ANDA #205663 |
SUPPL-5 |
LITHIUM CARBONATE |
UNIQUE |
Labeling |
Approval |
02/28/2020 |
OXYBUTYNIN CHLORIDE ANDA #206121 |
SUPPL-5 |
OXYBUTYNIN CHLORIDE |
UNIQUE |
Labeling |
Approval |
02/28/2020 |
PYRIMETHAMINE ANDA #207127 |
ORIG-1 |
PYRIMETHAMINE |
CEROVENE INC |
|
Approval |
02/28/2020 |
LANSOPRAZOLE ANDA #207156 |
SUPPL-1 |
LANSOPRAZOLE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/28/2020 |
LANSOPRAZOLE ANDA #207156 |
SUPPL-2 |
LANSOPRAZOLE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/28/2020 |
LANSOPRAZOLE ANDA #207156 |
SUPPL-3 |
LANSOPRAZOLE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
02/28/2020 |
MEMANTINE HYDROCHLORIDE ANDA #208173 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
HIKMA |
|
Approval |
02/28/2020 |
BYDUREON BCISE NDA #209210 |
SUPPL-11 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Labeling |
Approval |
02/28/2020 |
TERIFLUNOMIDE ANDA #209702 |
ORIG-1 |
TERIFLUNOMIDE |
NORVIUM BIOSCIENCE |
|
Approval |
02/28/2020 |
DIHYDROERGOTAMINE MESYLATE ANDA #211393 |
ORIG-1 |
DIHYDROERGOTAMINE MESYLATE |
HIKMA |
|
Approval |
02/28/2020 |
OXYBUTYNIN CHLORIDE ANDA #211655 |
SUPPL-1 |
OXYBUTYNIN CHLORIDE |
AJANTA PHARMA LTD |
Labeling |
Approval |
02/28/2020 |
ADVIL DUAL ACTION WITH ACETAMINOPHEN NDA #211733 |
ORIG-1 |
ACETAMINOPHEN; IBUPROFEN |
HALEON US HOLDINGS |
Type 4 - New Combination |
Approval |
02/28/2020 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE ANDA #212689 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
ZYDUS PHARMS |
|
Approval |
02/28/2020 |
DIVALPROEX SODIUM ANDA #213181 |
ORIG-1 |
DIVALPROEX SODIUM |
AJANTA PHARMA LTD |
|
Approval |
02/29/2020 |
NAPROXEN SODIUM ANDA #212033 |
SUPPL-1 |
NAPROXEN SODIUM |
YICHANG HUMANWELL |
Manufacturing (CMC) |
Approval |