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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 May 08, 2024.

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 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 PHARMS Labeling Approval
02/03/2020 OCTREOTIDE ACETATE
ANDA #204669		 SUPPL-1 OCTREOTIDE ACETATE HERITAGE PHARMS 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 WEST-WARD PHARMS INT 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 AIPING PHARM INC Labeling Approval
02/25/2020 MIRTAZAPINE
ANDA #076219		 SUPPL-25 MIRTAZAPINE AIPING PHARM INC 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 AKORN 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 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 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 MYLAN 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
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