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 October 01, 2020.

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 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 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 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 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 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 MEITHEAL 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 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 CADILA 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
02/10/2020 COLCHICINE
ANDA #210757
ORIG-1 COLCHICINE GRANULES PHARMS Tentative 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 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 EMCURE PHARMS LTD Labeling Approval
02/11/2020 RIFAMPIN
ANDA #204101
SUPPL-7 RIFAMPIN EMCURE PHARMS LTD Labeling Approval
02/11/2020 RIFAMPIN
ANDA #204101
SUPPL-8 RIFAMPIN EMCURE PHARMS LTD 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 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 ARCALYST
BLA #125249
SUPPL-45 RILONACEPT REGENERON PHARMACEUTICALS 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 MAYNE PHARMA INC Labeling Approval
02/12/2020 OXYCODONE HYDROCHLORIDE
ANDA #204092
SUPPL-7 OXYCODONE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
02/12/2020 LAMOTRIGINE
ANDA #204158
SUPPL-2 LAMOTRIGINE PAR PHARM Labeling Approval
02/12/2020 LAMOTRIGINE
ANDA #204158
SUPPL-3 LAMOTRIGINE PAR PHARM Labeling Approval
02/12/2020 LAMOTRIGINE
ANDA #204158
SUPPL-4 LAMOTRIGINE PAR PHARM 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 GLASSHOUSE PHARMS Labeling Approval
02/12/2020 CLINDAMYCIN PHOSPHATE
ANDA #209846
SUPPL-4 CLINDAMYCIN PHOSPHATE GLASSHOUSE PHARMS 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 GLAXOSMITHKLINE CONS 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 PHARMS LTD Labeling Approval
02/14/2020 LITHIUM CARBONATE
ANDA #204445
SUPPL-3 LITHIUM CARBONATE ALEMBIC PHARMS LTD Labeling Approval
02/14/2020 LITHIUM CARBONATE
ANDA #204445
SUPPL-5 LITHIUM CARBONATE ALEMBIC PHARMS LTD Labeling Approval
02/14/2020 LITHIUM CARBONATE
ANDA #204779
SUPPL-2 LITHIUM CARBONATE UNIQUE PHARM LABS Labeling Approval
02/14/2020 LITHIUM CARBONATE
ANDA #204779
SUPPL-3 LITHIUM CARBONATE UNIQUE PHARM LABS Labeling Approval
02/14/2020 LITHIUM CARBONATE
ANDA #204779
SUPPL-4 LITHIUM CARBONATE UNIQUE PHARM LABS 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 PHARMA USA 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 HERITAGE PHARMA Labeling Approval
02/18/2020 KETOCONAZOLE
ANDA #076942
SUPPL-24 KETOCONAZOLE TOLMAR 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 LABS LTD Approval
02/18/2020 MELPHALAN HYDROCHLORIDE
ANDA #210947
ORIG-1 MELPHALAN HYDROCHLORIDE INGENUS PHARMS LLC Approval
02/18/2020 PREGABALIN
ANDA #211593
ORIG-1 PREGABALIN ALVOGEN PINE BROOK Tentative 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 INC 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 TEIKOKU PHARMA Labeling Approval
02/19/2020 OLOPATADINE HYDROCHLORIDE
ANDA #208637
ORIG-1 OLOPATADINE HYDROCHLORIDE WATSON LABS INC Approval
02/19/2020 ZOLEDRONIC ACID
ANDA #208968
ORIG-1 ZOLEDRONIC ACID INGENUS PHARMS LLC 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 PHARMS 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 Approval
02/20/2020 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #213413
ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE LEADING PHARMA LLC 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 MAYNE PHARMA 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 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 CADILA Labeling Approval
02/21/2020 SERTRALINE HYDROCHLORIDE
ANDA #077106
SUPPL-7 SERTRALINE HYDROCHLORIDE CADILA 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 Labeling Approval
02/21/2020 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077375
SUPPL-11 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE MYLAN 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 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 FOSUN PHARMA 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 MYLAN PHARMS INC Labeling Approval
02/21/2020 SERTRALINE HYDROCHLORIDE
ANDA #078626
SUPPL-14 SERTRALINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
02/21/2020 SERTRALINE HYDROCHLORIDE
ANDA #078626
SUPPL-15 SERTRALINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
02/21/2020 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #079047
SUPPL-10 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE MYLAN 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 UPJOHN 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 PAR STERILE PRODUCTS 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 NOVELGENIX THERAPS 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 AUROBINDO PHARMA LTD Labeling Approval
02/21/2020 ZOLEDRONIC ACID
ANDA #207751
SUPPL-2 ZOLEDRONIC ACID AUROBINDO PHARMA LTD Labeling Approval
02/21/2020 NINLARO
NDA #208462
SUPPL-6 IXAZOMIB CITRATE MILLENNIUM PHARMS 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 PEMFEXY
NDA #209472
SUPPL-1 PEMETREXED EAGLE PHARMS Manufacturing (CMC) Tentative Approval
02/21/2020 TADALAFIL
ANDA #210069
SUPPL-2 TADALAFIL DR REDDYS LABS LTD Manufacturing (CMC) Approval
02/21/2020 GLYCOPYRROLATE
ANDA #210083
ORIG-1 GLYCOPYRROLATE RICONPHARMA LLC Approval
02/21/2020 ZOLEDRONIC ACID
ANDA #210174
SUPPL-1 ZOLEDRONIC ACID PUNISKA 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 SANDOZ Labeling Approval
02/24/2020 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091273
SUPPL-10 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE SANDOZ 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 MYLAN 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 PERRIGO PHARMS CO 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 BRECKENRIDGE 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 LUPIN LTD Labeling Approval
02/24/2020 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #204990
SUPPL-6 ABACAVIR SULFATE; LAMIVUDINE LUPIN LTD Labeling Approval
02/24/2020 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #204990
SUPPL-7 ABACAVIR SULFATE; LAMIVUDINE LUPIN LTD 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 ASENAPINE MALEATE
ANDA #206107
ORIG-1 ASENAPINE MALEATE SIGMAPHARM LABS LLC Tentative 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 PAR PHARM INC 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 PHARMA GLOBAL Labeling Approval
02/25/2020 DOCETAXEL
NDA #022534
SUPPL-11 DOCETAXEL SUN PHARMA GLOBAL Labeling Approval
02/25/2020 MIRTAZAPINE
ANDA #076219
SUPPL-24 MIRTAZAPINE UPSHER SMITH LABS Labeling Approval
02/25/2020 MIRTAZAPINE
ANDA #076219
SUPPL-25 MIRTAZAPINE UPSHER SMITH LABS 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 DISCOVERY THERAP Labeling Approval
02/25/2020 RANOLAZINE
ANDA #201046
SUPPL-1 RANOLAZINE LUPIN LTD Labeling Approval
02/25/2020 RANOLAZINE
ANDA #201046
SUPPL-2 RANOLAZINE LUPIN LTD Labeling Approval
02/25/2020 RANOLAZINE
ANDA #201046
SUPPL-4 RANOLAZINE LUPIN LTD Labeling Approval
02/25/2020 RANOLAZINE
ANDA #201046
SUPPL-7 RANOLAZINE LUPIN LTD 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 Approval
02/27/2020 EXCEDRIN (MIGRAINE)
NDA #020802
SUPPL-34 ACETAMINOPHEN; ASPIRIN; CAFFEINE GLAXOSMITHKLINE CONS Labeling Approval
02/27/2020 NAPROXEN SODIUM
NDA #021920
SUPPL-27 NAPROXEN SODIUM BIONPHARMA INC 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 HI TECH PHARMA 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 BIOHAVEN PHARM 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 MYLAN LABS LTD 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 SUCROFERRIC 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 INC Approval
02/28/2020 LITHIUM CARBONATE
ANDA #205663
SUPPL-5 LITHIUM CARBONATE UNIQUE PHARM LABS Labeling Approval
02/28/2020 OXYBUTYNIN CHLORIDE
ANDA #206121
SUPPL-5 OXYBUTYNIN CHLORIDE UNIQUE PHARM LABS Labeling Approval
02/28/2020 PYRIMETHAMINE
ANDA #207127
ORIG-1 PYRIMETHAMINE CEROVENE INC Approval
02/28/2020 LANSOPRAZOLE
ANDA #207156
SUPPL-1 LANSOPRAZOLE LANNETT CO INC Labeling Approval
02/28/2020 LANSOPRAZOLE
ANDA #207156
SUPPL-2 LANSOPRAZOLE LANNETT CO INC Labeling Approval
02/28/2020 LANSOPRAZOLE
ANDA #207156
SUPPL-3 LANSOPRAZOLE LANNETT CO INC 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 ASTRAZENECA AB Labeling Approval
02/28/2020 TERIFLUNOMIDE
ANDA #209702
ORIG-1 TERIFLUNOMIDE MYLAN Approval
02/28/2020 DIHYDROERGOTAMINE MESYLATE
ANDA #211393
ORIG-1 DIHYDROERGOTAMINE MESYLATE CUSTOPHARM INC 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 GLAXOSMITHKLINE 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 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #212689
ORIG-2 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE ZYDUS PHARMS Tentative 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

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