Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2020

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

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

This report was produced on February 16, 2020.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
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 GENERICS Labeling Approval
02/02/2020 INDOMETHACIN
ANDA #091276
SUPPL-4 INDOMETHACIN GLENMARK GENERICS Labeling Approval
02/02/2020 INDOMETHACIN
ANDA #091549
SUPPL-9 INDOMETHACIN AMNEAL PHARMS Labeling 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 PHARMS INC Labeling Approval
02/03/2020 OCTREOTIDE ACETATE
ANDA #204669
SUPPL-1 OCTREOTIDE ACETATE HERITAGE PHARMS INC Labeling Approval
02/03/2020 DECITABINE
NDA #205582
SUPPL-12 DECITABINE SUN PHARMA GLOBAL 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 TASIMELTEON
ANDA #211607
ORIG-1 TASIMELTEON APOTEX CORP Tentative Approval
02/03/2020 CYCLOPHOSPHAMIDE
ANDA #211608
SUPPL-2 CYCLOPHOSPHAMIDE CIPLA Labeling Approval
02/04/2020 ORAVIG
NDA #022404
SUPPL-5 MICONAZOLE FORTOVIA 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 LTD Labeling Approval
02/04/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #083329
SUPPL-46 CHLORPROMAZINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/04/2020 ARIPIPRAZOLE
ANDA #090165
SUPPL-1 ARIPIPRAZOLE ZYDUS 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 MYLAN LABS LTD 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 YILING PHARM LTD Manufacturing (CMC) Approval
02/04/2020 ARIPIPRAZOLE
ANDA #202102
SUPPL-16 ARIPIPRAZOLE ALEMBIC PHARMS LTD 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 INC 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 INC 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 PHARMS 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 CHLORPROMAZINE HYDROCHLORIDE
ANDA #080365
SUPPL-167 CHLORPROMAZINE HYDROCHLORIDE DR REDDYS Labeling Approval
02/05/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #080439
SUPPL-225 CHLORPROMAZINE HYDROCHLORIDE SANDOZ 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 FOSUN PHARMA Labeling Approval
02/05/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #083329
SUPPL-47 CHLORPROMAZINE HYDROCHLORIDE WEST-WARD PHARMS INT 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 ZYDUS 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 GENERICS Labeling Approval
02/05/2020 ARIPIPRAZOLE
ANDA #202102
SUPPL-17 ARIPIPRAZOLE ALEMBIC PHARMS LTD 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 ORCHID HLTHCARE Labeling Approval
02/05/2020 ARIPIPRAZOLE
ANDA #202547
SUPPL-2 ARIPIPRAZOLE ORCHID HLTHCARE 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 IDEC INC Efficacy Approval
02/05/2020 ARIPIPRAZOLE
ANDA #204094
SUPPL-8 ARIPIPRAZOLE APOTEX INC 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 AUROLIFE PHARMA LLC 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 PHARM CO LTD Labeling Approval
02/05/2020 ABILIFY MYCITE KIT
NDA #207202
SUPPL-4 ARIPIPRAZOLE OTSUKA PHARM CO LTD 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 EYEVANCE 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 PHARMS 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 INC 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 SOMMER PHARMS II LLC Approval
02/06/2020 LEVALBUTEROL HYDROCHLORIDE
ANDA #207625
SUPPL-4 LEVALBUTEROL HYDROCHLORIDE AUROBINDO PHARMA LTD 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 PHARM INDS LTD Labeling Approval
02/07/2020 INFANTS' FEVERALL
NDA #018337
SUPPL-35 ACETAMINOPHEN TARO PHARM INDS LTD 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 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 AUROBINDO PHARMA LTD 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 LEADING PHARMA LLC Approval
02/07/2020 FULVESTRANT
ANDA #211422
ORIG-1 FULVESTRANT CHIA TAI TIANQING Approval
02/07/2020 DOXERCALCIFEROL
ANDA #211670
ORIG-1 DOXERCALCIFEROL NANJING KING-FRIEND Approval
02/07/2020 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211690
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE XIROMED 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 LABS LTD Labeling Approval
02/09/2020 TERIFLUNOMIDE
ANDA #209572
SUPPL-1 TERIFLUNOMIDE ALEMBIC PHARMS LTD Labeling Approval
02/10/2020 LOTREL
NDA #020364
SUPPL-66 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE NOVARTIS Labeling Approval
02/10/2020 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
ANDA #062938
SUPPL-16 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE PERRIGO CO TENNESSEE 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 PAR PHARM Labeling Approval
02/10/2020 LAMOTRIGINE
ANDA #201791
SUPPL-7 LAMOTRIGINE PAR PHARM Labeling Approval
02/10/2020 MORPHINE SULFATE
ANDA #202310
SUPPL-1 MORPHINE SULFATE LANNETT CO INC Labeling Approval
02/10/2020 MORPHINE SULFATE
ANDA #202310
SUPPL-3 MORPHINE SULFATE LANNETT CO INC 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 INC Labeling Approval
02/10/2020 MORPHINE SULFATE
ANDA #208809
SUPPL-2 MORPHINE SULFATE HI TECH Labeling Approval
02/10/2020 MORPHINE SULFATE
ANDA #208809
SUPPL-5 MORPHINE SULFATE HI TECH Labeling Approval
02/10/2020 FLUOCINONIDE
ANDA #208989
ORIG-1 FLUOCINONIDE ZYDUS PHARMS 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 Labeling Approval
02/11/2020 ZINACEF
NDA #050558
SUPPL-75 CEFUROXIME SODIUM TELIGENT Labeling Approval
02/11/2020 FORTAZ
NDA #050578
SUPPL-64 CEFTAZIDIME TELIGENT Labeling Approval
02/11/2020 CEFEPIME HYDROCHLORIDE
ANDA #203704
SUPPL-7 CEFEPIME HYDROCHLORIDE QILU Labeling Approval
02/11/2020 SPRAVATO
NDA #211243
SUPPL-3 ESKETAMINE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
02/12/2020 FORTAZ
NDA #050578
SUPPL-62 CEFTAZIDIME TELIGENT 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 KETOROLAC; PHENYLEPHRINE
ANDA #208417
ORIG-1 KETOROLAC;PHENYLEPHRINE PAR STERILE PRODUCTS Tentative Approval
02/12/2020 ALIQOPA
NDA #209936
SUPPL-4 COPANLISIB DIHYDROCHLORIDE BAYER HEALTHCARE Labeling Approval
02/12/2020 PIZENSY
NDA #211281
ORIG-1 LACTITOL MONOHYDRATE (BLI400) BRAINTREE LABS Type 1 - New Molecular Entity 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 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
02/13/2020 DEFERASIROX
ANDA #211852
ORIG-1 DEFERASIROX CIPLA Approval
02/13/2020 RANOLAZINE
ANDA #212284
ORIG-1 RANOLAZINE MANKIND PHARMA Approval
02/13/2020 URSODIOL
ANDA #213200
ORIG-1 URSODIOL RISING Approval
02/13/2020 CHLORTHALIDONE
ANDA #213412
ORIG-1 CHLORTHALIDONE ALKEM LABS LTD Approval
02/14/2020 PATANOL
NDA #020688
SUPPL-32 OLOPATADINE HYDROCHLORIDE NOVARTIS Efficacy Approval
02/14/2020 PATADAY
NDA #021545
SUPPL-22 OLOPATADINE HYDROCHLORIDE NOVARTIS Efficacy Approval
02/14/2020 VOLTAREN
NDA #022122
SUPPL-14 DICLOFENAC SODIUM GLAXOSMITHKLINE CONS Efficacy Approval

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