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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 2019

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 April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/03/2019 MIRALAX
NDA #022015		 SUPPL-35 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076737		 SUPPL-9 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076737		 SUPPL-13 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-8 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-9 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/03/2019 TESTOSTERONE
ANDA #076744		 SUPPL-10 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/03/2019 LANSOPRAZOLE
ANDA #201921		 SUPPL-6 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
06/03/2019 ELIQUIS
NDA #202155		 SUPPL-21 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
06/03/2019 ZYTIGA
NDA #202379		 SUPPL-27 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
06/03/2019 ZYTIGA
NDA #202379		 SUPPL-28 ABIRATERONE ACETATE JANSSEN BIOTECH Efficacy Approval
06/03/2019 BROMFENAC SODIUM
ANDA #203368		 ORIG-1 BROMFENAC SODIUM RISING Approval
06/03/2019 ZERBAXA
NDA #206829		 SUPPL-8 CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC Efficacy Approval
06/03/2019 EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206894		 ORIG-1 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE CIPLA Approval
06/03/2019 TESTOSTERONE
ANDA #208560		 SUPPL-1 TESTOSTERONE LUPIN Labeling Approval
06/03/2019 LEVOTHYROXINE SODIUM
ANDA #209713		 SUPPL-3 LEVOTHYROXINE SODIUM LUPIN Manufacturing (CMC) Approval
06/03/2019 LEFLUNOMIDE
ANDA #212453		 ORIG-1 LEFLUNOMIDE ABHAI LLC Approval
06/04/2019 TESTOSTERONE
ANDA #208061		 SUPPL-2 TESTOSTERONE LUPIN LTD REMS Approval
06/04/2019 TESTOSTERONE
ANDA #208620		 SUPPL-1 TESTOSTERONE ENCUBE Labeling Approval
06/04/2019 TESTOSTERONE
ANDA #208620		 SUPPL-2 TESTOSTERONE ENCUBE Labeling Approval
06/04/2019 TESTOSTERONE
ANDA #209533		 SUPPL-4 TESTOSTERONE CIPLA REMS Approval
06/04/2019 RANOLAZINE
ANDA #211829		 ORIG-1 RANOLAZINE SCIEGEN PHARMS INC Approval
06/04/2019 EMGALITY
BLA #761063		 SUPPL-3 GALCANEZUMAB-GNLM ELI LILLY AND CO Approval
06/05/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #209716		 ORIG-1 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Approval
06/05/2019 CARBIDOPA AND LEVODOPA
ANDA #210341		 ORIG-1 CARBIDOPA; LEVODOPA ALEMBIC Approval
06/06/2019 TAXOTERE
NDA #020449		 SUPPL-80 DOCETAXEL SANOFI AVENTIS US Labeling Approval
06/06/2019 TAXOTERE
NDA #020449		 SUPPL-82 DOCETAXEL SANOFI AVENTIS US Labeling Approval
06/06/2019 NUCALA
BLA #125526		 SUPPL-13 MEPOLIZUMAB GLAXOSMITHKLINE LLC Approval
06/06/2019 ANORO ELLIPTA
NDA #203975		 SUPPL-10 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Efficacy Approval
06/06/2019 INCRUSE ELLIPTA
NDA #205382		 SUPPL-10 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Efficacy Approval
06/06/2019 DESMOPRESSIN ACETATE
ANDA #208357		 ORIG-1 DESMOPRESSIN ACETATE NOVAST LABS Approval
06/06/2019 NUCALA
BLA #761122		 ORIG-1 MEPOLIZUMAB GLAXOSMITHKLINE Approval
06/07/2019 THALOMID
NDA #020785		 SUPPL-67 THALIDOMIDE BRISTOL-MYERS Labeling Approval
06/07/2019 TINDAMAX
NDA #021618		 SUPPL-6 TINIDAZOLE MISSION PHARMA Labeling Approval
06/07/2019 VIVITROL
NDA #021897		 SUPPL-44 NALTREXONE ALKERMES REMS Approval
06/07/2019 EMFLAZA
NDA #208684		 SUPPL-3 DEFLAZACORT PTC THERAP Efficacy Approval
06/07/2019 EMFLAZA
NDA #208685		 SUPPL-3 DEFLAZACORT PTC THERAP Efficacy Approval
06/07/2019 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #210967		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE EUGIA PHARMA Approval
06/10/2019 KEYTRUDA
BLA #125514		 SUPPL-52 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/10/2019 OPSUMIT
NDA #204410		 SUPPL-19 MACITENTAN ACTELION REMS Approval
06/10/2019 ZEMBRACE SYMTOUCH
NDA #208223		 SUPPL-5 SUMATRIPTAN SUCCINATE TONIX MEDS Efficacy Approval
06/10/2019 NIACIN
ANDA #212017		 ORIG-1 NIACIN YICHANG HUMANWELL Approval
06/10/2019 POLIVY
BLA #761121		 ORIG-1 POLATUZUMAB VEDOTIN-PIIQ GENENTECH Approval
06/11/2019 FURADANTIN
NDA #009175		 SUPPL-46 NITROFURANTOIN CASPER PHARMA LLC Labeling Approval
06/11/2019 PEPCID COMPLETE
NDA #020958		 SUPPL-29 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE J AND J CONSUMER INC Labeling Approval
06/11/2019 MEN'S ROGAINE
NDA #021812		 SUPPL-14 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
06/11/2019 WOMEN'S ROGAINE
NDA #021812		 SUPPL-14 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
06/11/2019 NUEDEXTA
NDA #021879		 SUPPL-14 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE AVANIR PHARMS Labeling Approval
06/11/2019 VIMPAT
NDA #022253		 SUPPL-45 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 VIMPAT
NDA #022254		 SUPPL-35 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 VIMPAT
NDA #022255		 SUPPL-26 LACOSAMIDE UCB INC Labeling Approval
06/11/2019 PROGRAF
NDA #050708		 SUPPL-50 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 PROGRAF
NDA #050709		 SUPPL-42 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 ACTEMRA
BLA #125276		 SUPPL-127 TOCILIZUMAB GENENTECH Approval
06/11/2019 ACTEMRA
BLA #125472		 SUPPL-40 TOCILIZUMAB GENENTECH Approval
06/11/2019 QUETIAPINE FUMARATE
ANDA #202939		 SUPPL-2 QUETIAPINE FUMARATE INTELLIPHARMACEUTICS Manufacturing (CMC) Approval
06/11/2019 ASTAGRAF XL
NDA #204096		 SUPPL-7 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 TESTOSTERONE
ANDA #205328		 SUPPL-2 TESTOSTERONE ACTAVIS LABS UT INC REMS Approval
06/11/2019 TIGECYCLINE
ANDA #206335		 ORIG-1 TIGECYCLINE EUGIA PHARMA Approval
06/11/2019 POTASSIUM CHLORIDE
ANDA #209026		 ORIG-1 POTASSIUM CHLORIDE PRINSTON INC Approval
06/11/2019 PROGRAF
NDA #210115		 SUPPL-2 TACROLIMUS ASTELLAS Labeling Approval
06/11/2019 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA #210663		 ORIG-1 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE NOSTRUM LABS INC Approval
06/12/2019 DIOVAN HCT
NDA #020818		 SUPPL-75 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 DIOVAN
NDA #021283		 SUPPL-53 VALSARTAN NOVARTIS Labeling Approval
06/12/2019 EXFORGE
NDA #021990		 SUPPL-33 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 EXFORGE HCT
NDA #022314		 SUPPL-27 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
06/12/2019 BUPROPION HYDROCHLORIDE
ANDA #077284		 SUPPL-42 BUPROPION HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
06/12/2019 MESALAMINE
ANDA #202065		 ORIG-1 MESALAMINE SANDOZ Approval
06/12/2019 PALIPERIDONE
ANDA #204452		 ORIG-1 PALIPERIDONE INVENTIA Approval
06/12/2019 LORATADINE
ANDA #210033		 ORIG-1 LORATADINE PERRIGO PHARMA INTL Approval
06/12/2019 DAPAGLIFLOZIN
ANDA #211545		 ORIG-1 DAPAGLIFLOZIN ALKEM LABS LTD Tentative Approval
06/12/2019 VANCOMYCIN HYDROCHLORIDE
ANDA #212332		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HAINAN POLY PHARM Approval
06/13/2019 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-101 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
06/13/2019 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #205295		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE FDC LTD Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-2 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-3 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209816		 SUPPL-4 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-1 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-2 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 NUZYRA
NDA #209817		 SUPPL-3 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
06/13/2019 ORTIKOS
NDA #211929		 ORIG-1 BUDESONIDE SUN PHARM INDS INC Type 5 - New Formulation or New Manufacturer Approval
06/13/2019 AMJEVITA
BLA #761024		 SUPPL-4 ADALIMUMAB-ATTO AMGEN INC Approval
06/13/2019 KANJINTI
BLA #761073		 ORIG-1 TRASTUZUMAB-ANNS AMGEN INC Approval
06/14/2019 LOTRISONE
NDA #018827		 SUPPL-50 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE ORGANON Labeling Approval
06/14/2019 SOMATULINE DEPOT
NDA #022074		 SUPPL-21 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
06/14/2019 TRAMADOL HYDROCHLORIDE
ANDA #202075		 SUPPL-2 TRAMADOL HYDROCHLORIDE ACI REMS Approval
06/14/2019 APTENSIO XR
NDA #205831		 SUPPL-5 METHYLPHENIDATE HYDROCHLORIDE RHODES PHARMS Efficacy Approval
06/14/2019 DILTIAZEM HYDROCHLORIDE
ANDA #208783		 ORIG-1 DILTIAZEM HYDROCHLORIDE NOVAST LABS Approval
06/14/2019 OMEGA-3-ACID ETHYL ESTERS
ANDA #210107		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS ZYDUS LIFESCIENCES Approval
06/15/2019 CARBON DIOXIDE, USP
NDA #213507		 ORIG-1 CARBON DIOXIDE A-OX WELDING SUPPLY CO, INC. Medical Gas Approval
06/17/2019 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-31 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
06/17/2019 CLARITIN
NDA #021891		 SUPPL-31 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
06/17/2019 VICTOZA
NDA #022341		 SUPPL-31 LIRAGLUTIDE NOVO NORDISK INC Efficacy Approval
06/17/2019 KEYTRUDA
BLA #125514		 SUPPL-53 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/17/2019 SPINRAZA
NDA #209531		 SUPPL-7 NUSINERSEN SODIUM BIOGEN IDEC Labeling Approval
06/17/2019 SPINRAZA
NDA #209531		 SUPPL-8 NUSINERSEN SODIUM BIOGEN IDEC Labeling Approval
06/17/2019 POTASSIUM CHLORIDE
ANDA #210097		 ORIG-1 POTASSIUM CHLORIDE STRIDES PHARMA Approval
06/18/2019 RAPAMUNE
NDA #021083		 SUPPL-66 SIROLIMUS PF PRISM CV Labeling Approval
06/18/2019 HALOPERIDOL DECANOATE
ANDA #075305		 SUPPL-22 HALOPERIDOL DECANOATE HIKMA Manufacturing (CMC) Approval
06/18/2019 INFLECTRA
BLA #125544		 SUPPL-9 INFLIXIMAB-DYYB CELLTRION INC Approval
06/18/2019 ACETAZOLAMIDE
ANDA #203917		 ORIG-1 ACETAZOLAMIDE RISING Approval
06/18/2019 ONZETRA XSAIL
NDA #206099		 SUPPL-5 SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
06/18/2019 DICLOFENAC SODIUM
ANDA #208786		 ORIG-1 DICLOFENAC SODIUM RISING Approval
06/18/2019 BIKTARVY
NDA #210251		 SUPPL-5 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
06/18/2019 XERAVA
NDA #211109		 SUPPL-1 ERAVACYCLINE DIHYDROCHLORIDE TETRAPHASE PHARMS Manufacturing (CMC) Approval
06/19/2019 QUALAQUIN
NDA #021799		 SUPPL-29 QUININE SULFATE SUN PHARM INDUSTRIES Labeling Approval
06/19/2019 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-81 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
06/19/2019 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-40 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
06/19/2019 SCOPOLAMINE
ANDA #203753		 ORIG-1 SCOPOLAMINE MYLAN TECHNOLOGIES Approval
06/19/2019 IMMPHENTIV
NDA #203826		 SUPPL-9 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
06/19/2019 PHENYLEPHRINE HYDROCHLORIDE
NDA #203826		 SUPPL-9 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
06/19/2019 MYCOPHENOLATE MOFETIL
ANDA #204077		 SUPPL-1 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM Manufacturing (CMC) Approval
06/19/2019 OTREXUP
NDA #204824		 SUPPL-9 METHOTREXATE OTTER PHARMS Labeling Approval
06/19/2019 OTREXUP PFS
NDA #204824		 SUPPL-9 METHOTREXATE OTTER PHARMS Labeling Approval
06/19/2019 BIMATOPROST
ANDA #207601		 ORIG-1 BIMATOPROST SOMERSET THERAPS LLC Approval
06/20/2019 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-20 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/20/2019 POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-20 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/20/2019 POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-20 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/20/2019 POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-20 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/20/2019 TRISENOX
NDA #021248		 SUPPL-18 ARSENIC TRIOXIDE CEPHALON Labeling Approval
06/20/2019 VANCOCIN HYDROCHLORIDE
ANDA #061667		 SUPPL-26 VANCOMYCIN HYDROCHLORIDE ANI PHARMS Labeling Approval
06/20/2019 BOTOX
BLA #103000		 SUPPL-5309 OnabotulinumtoxinA ALLERGAN Approval
06/20/2019 BOTOX COSMETIC
BLA #103000		 SUPPL-5309 OnabotulinumtoxinA ALLERGAN Approval
06/20/2019 AVASTIN
BLA #125085		 SUPPL-331 BEVACIZUMAB GENENTECH Approval
06/20/2019 KETOROLAC TROMETHAMINE
ANDA #203492		 ORIG-1 KETOROLAC TROMETHAMINE MICRO LABS LTD INDIA Tentative Approval
06/20/2019 MYXREDLIN
BLA #208157		 ORIG-1 INSULIN HUMAN BAXTER HLTHCARE CORP Approval
06/20/2019 DEXTENZA
NDA #208742		 SUPPL-1 DEXAMETHASONE OCULAR THERAPEUTIX Efficacy Approval
06/20/2019 SODIUM BICARBONATE
ANDA #211091		 ORIG-1 SODIUM BICARBONATE EXELA PHARMA Approval
06/20/2019 GANCICLOVIR SODIUM
ANDA #212001		 ORIG-1 GANCICLOVIR SODIUM CUSTOPHARM INC Approval
06/21/2019 COLAZAL
NDA #020610		 SUPPL-21 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
06/21/2019 TESTOSTERONE
ANDA #091073		 SUPPL-2 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/21/2019 GEMCITABINE HYDROCHLORIDE
NDA #200795		 SUPPL-10 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
06/21/2019 DOCETAXEL
NDA #201195		 SUPPL-13 DOCETAXEL ACCORD HLTHCARE Labeling Approval
06/21/2019 TESTOSTERONE
ANDA #204571		 SUPPL-3 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/21/2019 TESTOSTERONE
ANDA #204571		 SUPPL-5 TESTOSTERONE ACTAVIS LABS UT INC Labeling Approval
06/21/2019 CAPECITABINE
ANDA #204668		 ORIG-1 CAPECITABINE SUN PHARM Approval
06/21/2019 DEXTROAMPHETAMINE SULFATE
ANDA #205077		 ORIG-1 DEXTROAMPHETAMINE SULFATE STRIDES PHARMA Approval
06/21/2019 LINEZOLID
ANDA #205442		 SUPPL-1 LINEZOLID HOSPIRA Labeling Approval
06/21/2019 LINEZOLID
ANDA #205442		 SUPPL-2 LINEZOLID HOSPIRA Labeling Approval
06/21/2019 TESTOSTERONE
ANDA #207373		 SUPPL-1 TESTOSTERONE AMNEAL Labeling Approval
06/21/2019 MESALAMINE
ANDA #208362		 ORIG-1 MESALAMINE AMRING PHARMS Approval
06/21/2019 SYMDEKO (COPACKAGED)
NDA #210491		 SUPPL-3 IVACAFTOR; IVACAFTOR, TEZACAFTOR VERTEX PHARMS INC Efficacy Approval
06/21/2019 VYLEESI (AUTOINJECTOR)
NDA #210557		 ORIG-1 BREMELANOTIDE ACETATE PALATIN TECHNOLOGIES Type 1 - New Molecular Entity Approval
06/21/2019 BROMFENAC SODIUM
ANDA #210560		 ORIG-1 BROMFENAC SODIUM ALEMBIC Approval
06/24/2019 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-11 TOPOTECAN HYDROCHLORIDE MEITHEAL Labeling Approval
06/24/2019 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #091348		 SUPPL-10 SULFAMETHOXAZOLE; TRIMETHOPRIM AUROBINDO PHARMA Manufacturing (CMC) Approval
06/24/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-20 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
06/24/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 SUPPL-6 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
06/24/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #202289		 SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
06/24/2019 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #204832		 SUPPL-3 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM UNICHEM Labeling Approval
06/24/2019 LONHALA MAGNAIR KIT
NDA #208437		 SUPPL-3 GLYCOPYRROLATE SUMITOMO PHARMA AM Labeling Approval
06/24/2019 PENICILLAMINE
ANDA #210976		 ORIG-1 PENICILLAMINE WATSON LABS INC Approval
06/24/2019 OSELTAMIVIR PHOSPHATE
ANDA #211823		 ORIG-1 OSELTAMIVIR PHOSPHATE ALEMBIC Approval
06/24/2019 DAPTOMYCIN
ANDA #211961		 ORIG-1 DAPTOMYCIN ACCORD HLTHCARE Approval
06/24/2019 MVASI
BLA #761028		 SUPPL-4 BEVACIZUMAB-AWWB AMGEN INC Approval
06/25/2019 XALKORI
NDA #202570		 SUPPL-28 CRIZOTINIB PF PRISM CV Labeling Approval
06/25/2019 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #207523		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOMERSET Approval
06/25/2019 GEMCITABINE HYDROCHLORIDE
NDA #209604		 SUPPL-4 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
06/25/2019 SPRAVATO
NDA #211243		 SUPPL-2 ESKETAMINE HYDROCHLORIDE JANSSEN PHARMS REMS Approval
06/26/2019 ZAVESCA
NDA #021348		 SUPPL-15 MIGLUSTAT ACTELION Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-8 CLOPIDOGREL BISULFATE RISING Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-9 CLOPIDOGREL BISULFATE RISING Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-10 CLOPIDOGREL BISULFATE RISING Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #077665		 SUPPL-11 CLOPIDOGREL BISULFATE RISING Labeling Approval
06/26/2019 LINEZOLID
ANDA #200222		 SUPPL-4 LINEZOLID TEVA PHARMS Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-8 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-9 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-11 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-14 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
06/26/2019 CLOPIDOGREL BISULFATE
ANDA #202928		 SUPPL-15 CLOPIDOGREL BISULFATE MACLEODS PHARMS LTD Labeling Approval
06/26/2019 DOXYCYCLINE HYCLATE
ANDA #208818		 SUPPL-1 DOXYCYCLINE HYCLATE LUPIN LTD Labeling Approval
06/26/2019 DAPSONE
ANDA #210191		 ORIG-1 DAPSONE TARO Approval
06/26/2019 DOPTELET
NDA #210238		 SUPPL-1 AVATROMBOPAG MALEATE AKARX INC Efficacy Approval
06/26/2019 TOBRAMYCIN
ANDA #210915		 ORIG-1 TOBRAMYCIN TEVA PHARMS USA Approval
06/26/2019 DAPAGLIFLOZIN
ANDA #211467		 ORIG-1 DAPAGLIFLOZIN MICRO LABS LTD Tentative Approval
06/26/2019 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #212231		 ORIG-1 SULFAMETHOXAZOLE; TRIMETHOPRIM SOMERSET Approval
06/26/2019 DAPTOMYCIN
ANDA #212513		 ORIG-1 DAPTOMYCIN BE PHARMS Approval
06/26/2019 RENFLEXIS
BLA #761054		 SUPPL-9 INFLIXIMAB-ABDA SAMSUNG BIOEPIS CO LTD Approval
06/26/2019 DUPIXENT
BLA #761055		 SUPPL-14 DUPILUMAB REGENERON PHARMACEUTICALS Approval
06/27/2019 FLUDEOXYGLUCOSE F18
NDA #021870		 SUPPL-15 FLUDEOXYGLUCOSE F-18 FEINSTEIN Labeling Approval
06/27/2019 SOLIRIS
BLA #125166		 SUPPL-431 ECULIZUMAB ALEXION PHARM Approval
06/27/2019 TESTOSTERONE
ANDA #204268		 SUPPL-4 TESTOSTERONE PADAGIS ISRAEL Labeling Approval
06/27/2019 LINEZOLID
ANDA #205154		 SUPPL-1 LINEZOLID MYLAN LABS LTD Labeling Approval
06/27/2019 LINEZOLID
ANDA #205154		 SUPPL-3 LINEZOLID MYLAN LABS LTD Labeling Approval
06/27/2019 TESTOSTERONE
ANDA #205781		 SUPPL-4 TESTOSTERONE PADAGIS ISRAEL Labeling Approval
06/27/2019 LINEZOLID
ANDA #206917		 SUPPL-1 LINEZOLID EUGIA PHARMA Labeling Approval
06/27/2019 EZETIMIBE AND SIMVASTATIN
ANDA #208699		 ORIG-1 EZETIMIBE; SIMVASTATIN GLENMARK PHARMS LTD Approval
06/27/2019 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #211610		 ORIG-1 ACETAMINOPHEN; CODEINE PHOSPHATE WES PHARMA INC Approval
06/27/2019 METHYLPREDNISOLONE
ANDA #212262		 ORIG-1 METHYLPREDNISOLONE PRAXGEN Approval
06/27/2019 DARZALEX
BLA #761036		 SUPPL-20 DARATUMUMAB JANSSEN BIOTECH Approval
06/27/2019 ZIRABEV
BLA #761099		 ORIG-1 BEVACIZUMAB-BVZR PFIZER INC Approval
06/28/2019 ANTIVERT
NDA #010721		 SUPPL-63 MECLIZINE HYDROCHLORIDE CASPER PHARMA LLC Efficacy Approval
06/28/2019 THIOLA
NDA #019569		 SUPPL-6 TIOPRONIN MISSION PHARMA Labeling Approval
06/28/2019 LEVAQUIN
NDA #020634		 SUPPL-71 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
06/28/2019 ERY-TAB
ANDA #062298		 SUPPL-72 ERYTHROMYCIN AZURITY Labeling Approval
06/28/2019 MINOCYCLINE HYDROCHLORIDE
ANDA #065485		 SUPPL-11 MINOCYCLINE HYDROCHLORIDE BARR LABS INC Labeling Approval
06/28/2019 FLUCONAZOLE
ANDA #077253		 SUPPL-14 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 FLUCONAZOLE
ANDA #077253		 SUPPL-16 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 FLUCONAZOLE
ANDA #077253		 SUPPL-17 FLUCONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090041		 SUPPL-5 MEMANTINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090043		 SUPPL-6 MEMANTINE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090048		 SUPPL-5 MEMANTINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090051		 SUPPL-2 MEMANTINE HYDROCHLORIDE LUPIN LTD Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090244		 SUPPL-1 MEMANTINE HYDROCHLORIDE CHARTWELL Labeling Approval
06/28/2019 LANSOPRAZOLE
ANDA #090331		 SUPPL-16 LANSOPRAZOLE SANDOZ Labeling Approval
06/28/2019 LANSOPRAZOLE
ANDA #090331		 SUPPL-18 LANSOPRAZOLE SANDOZ Labeling Approval
06/28/2019 LANSOPRAZOLE
ANDA #090331		 SUPPL-19 LANSOPRAZOLE SANDOZ Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #090961		 SUPPL-1 MEMANTINE HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
06/28/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091264		 SUPPL-8 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Labeling Approval
06/28/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091264		 SUPPL-10 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #202840		 SUPPL-9 MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #203175		 SUPPL-4 MEMANTINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
06/28/2019 VORICONAZOLE
ANDA #203503		 SUPPL-1 VORICONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 VORICONAZOLE
ANDA #203503		 SUPPL-2 VORICONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 VORICONAZOLE
ANDA #203503		 SUPPL-3 VORICONAZOLE GLENMARK PHARMS LTD Labeling Approval
06/28/2019 TRANEXAMIC ACID
ANDA #203521		 SUPPL-10 TRANEXAMIC ACID AVET LIFESCIENCES Labeling Approval
06/28/2019 LINEZOLID
ANDA #204696		 SUPPL-2 LINEZOLID SAGENT PHARMS INC Labeling Approval
06/28/2019 PEMETREXED
ANDA #205238		 ORIG-1 PEMETREXED SUN PHARM INDS LTD Tentative Approval
06/28/2019 MEMANTINE HYDROCHLORIDE
ANDA #206855		 SUPPL-1 MEMANTINE HYDROCHLORIDE PURACAP PHARM LLC Labeling Approval
06/28/2019 TRAMADOL HYDROCHLORIDE
ANDA #208708		 ORIG-1 TRAMADOL HYDROCHLORIDE RUBICON Approval
06/28/2019 CINACALCET HYDROCHLORIDE
ANDA #210548		 ORIG-1 CINACALCET HYDROCHLORIDE LUPIN LTD Approval
06/28/2019 CLONAZEPAM
ANDA #211033		 ORIG-1 CLONAZEPAM ALEMBIC Approval
06/28/2019 ISOPROTERENOL HYDROCHLORIDE
ANDA #211738		 ORIG-1 ISOPROTERENOL HYDROCHLORIDE CIPLA Approval
06/28/2019 THIOLA EC
NDA #211843		 ORIG-1 TIOPRONIN MISSION PHARMACAL Type 3 - New Dosage Form Approval
06/28/2019 OGIVRI
BLA #761074		 SUPPL-5 TRASTUZUMAB-DKST MYLAN GMBH Approval
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