Thursday, September 19, 2019

Thursday, September 19, 2019

FDA OK'd 227 drugs in June


The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.

The list includes original and supplemental approvals for new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs), the FDA said. Supplemental approvals might have been granted in the first week of April.

The FDA defines biologics as natural materials such as enzymes, antibodies or hormones in the human body.

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FDA Drug Approvals in June

Approval DateDrug NameSubmissionActive IngredientsCompanySubmission ClassificationSubmission Status
June 3MIRALAX NDA #022015SUPPL-35POLYETHYLENE GLYCOL 3350BAYER HEALTHCARE LLCLabelingApproval
June 3TESTOSTERONE ANDA #076737SUPPL-9TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
June 3TESTOSTERONE ANDA #076737SUPPL-13TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
June 3TESTOSTERONE ANDA #076744SUPPL-8TESTOSTERONEPAR PHARMLabelingApproval
June 3TESTOSTERONE ANDA #076744SUPPL-9TESTOSTERONEPAR PHARMLabelingApproval
June 3TESTOSTERONE ANDA #076744SUPPL-10TESTOSTERONEPAR PHARMLabelingApproval
June 3LANSOPRAZOLE ANDA #201921SUPPL-6LANSOPRAZOLENATCO PHARMA LTDLabelingApproval
June 3ELIQUIS NDA #202155SUPPL-21APIXABANBRISTOL MYERS SQUIBBLabelingApproval
June 3ZYTIGA NDA #202379SUPPL-27ABIRATERONE ACETATEJANSSEN BIOTECHLabelingApproval
June 3ZYTIGA NDA #202379SUPPL-28ABIRATERONE ACETATEJANSSEN BIOTECHEfficacyApproval
June 3BROMFENAC SODIUM ANDA #203368ORIG-1BROMFENAC SODIUMINNOPHARMA LICENSING

Approval
June 3ZERBAXA NDA #206829SUPPL-8CEFTOLOZANE SULFATE; TAZOBACTAM SODIUMCUBIST PHARMS LLCEfficacyApproval
June 3EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #206894ORIG-1EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATECIPLA

Approval
June 3ERLOTINIB ANDA #208396ORIG-1ERLOTINIBAPOTEX INC

Tentative Approval
June 3TESTOSTERONE ANDA #208560SUPPL-1TESTOSTERONELUPIN ATLANTISLabelingApproval
June 3LEFLUNOMIDE ANDA #212453ORIG-1LEFLUNOMIDEABHAI LLC

Approval
June 4TESTOSTERONE ANDA #208061SUPPL-2TESTOSTERONELUPIN LTDREMSApproval
June 4TESTOSTERONE ANDA #208620SUPPL-1TESTOSTERONEDR REDDYSLabelingApproval
June 4TESTOSTERONE ANDA #208620SUPPL-2TESTOSTERONEDR REDDYSLabelingApproval
June 4TESTOSTERONE ANDA #209533SUPPL-4TESTOSTERONECIPLAREMSApproval
June 4RANOLAZINE ANDA #211829ORIG-1RANOLAZINESCIEGEN PHARMS INC

Approval
June 4EMGALITY BLA #761063SUPPL-3GALCANEZUMAB-GNLMELI LILLY AND CO

Approval
June 5ESOMEPRAZOLE MAGNESIUM ANDA #209716ORIG-1ESOMEPRAZOLE MAGNESIUMAMNEAL PHARMS NY

Approval
June 5CARBIDOPA AND LEVODOPA ANDA #210341ORIG-1CARBIDOPA; LEVODOPAALEMBIC PHARMS LTD

Approval
June 6TAXOTERE NDA #020449SUPPL-80DOCETAXELSANOFI AVENTIS USLabelingApproval
June 6TAXOTERE NDA #020449SUPPL-82DOCETAXELSANOFI AVENTIS USLabelingApproval
June 6NUCALA BLA #125526SUPPL-13MEPOLIZUMABGLAXOSMITHKLINE LLC

Approval
June 6ANORO ELLIPTA NDA #203975SUPPL-10UMECLIDINIUM BROMIDE;

VILANTEROL TRIFENATATE

GLAXOSMITHKLINEEfficacyApproval
June 6INCRUSE ELLIPTA NDA #205382SUPPL-10UMECLIDINIUM BROMIDEGLAXO GRP ENGLANDEfficacyApproval
June 6DESMOPRESSIN ACETATE ANDA

#208357

ORIG-1DESMOPRESSIN ACETATENOVAST LABS

Approval
June 6NUCALA BLA #761122ORIG-1MEPOLIZUMABGLAXOSMITHKLINE

Approval
June 7THALOMID NDA #020785SUPPL-67THALIDOMIDECELGENELabelingApproval
June 7TINDAMAX NDA #021618SUPPL-6TINIDAZOLEMISSION PHARMALabelingApproval
June 7VIVITROL NDA #021897SUPPL-44NALTREXONEALKERMESREMSApproval
June 7EMFLAZA NDA #208684SUPPL-3DEFLAZACORTPTC THERAPEfficacyApproval
June 7EMFLAZA NDA #208685SUPPL-3DEFLAZACORTPTC THERAPEfficacyApproval
June 7TOFACITINIB ANDA #209633ORIG-1TOFACITINIBBRECKENRIDGE PHARMS

Tentative Approval
June 7DEXAMETHASONE SODIUM PHOSPHATE ANDA #210967ORIG-1DEXAMETHASONE SODIUM PHOSPHATEAUROBINDO PHARMA LTD

Approval
June 10KEYTRUDA BLA #125514SUPPL-52PEMBROLIZUMABMERCK SHARP DOHME

Approval
June 10OPSUMIT NDA #204410SUPPL-19MACITENTANACTELION PHARMS LTDREMSApproval
June 10ZEMBRACE SYMTOUCH NDA #208223SUPPL-5SUMATRIPTAN SUCCINATEDR REDDYSEfficacyApproval
June 10NIACIN ANDA #212017ORIG-1NIACINYICHANG HUMANWELL

Approval
June 10POLIVY BLA #761121ORIG-1POLATUZUMAB VEDOTIN-PIIQGENENTECH

Approval
June 11FURADANTIN NDA #009175SUPPL-46NITROFURANTOINCASPER PHARMA LLCLabelingApproval
June 11PEPCID COMPLETE NDA #020958SUPPL-29CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDEJ AND J CONSUMER INCLabelingApproval
June 11MEN'S ROGAINE NDA #021812SUPPL-14MINOXIDILJOHNSON AND JOHNSONLabelingApproval
June 11WOMEN'S ROGAINE NDA #021812SUPPL-14MINOXIDILJOHNSON AND JOHNSONLabelingApproval
June 11NUEDEXTA NDA #021879SUPPL-14DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE

SULFATE

AVANIR PHARMSLabelingApproval
June 11VIMPAT NDA #022253SUPPL-45LACOSAMIDEUCB INCLabelingApproval
June 11VIMPAT NDA #022254SUPPL-35LACOSAMIDEUCB INCLabelingApproval
June 11VIMPAT NDA #022255SUPPL-26LACOSAMIDEUCB INCLabelingApproval
June 11PROGRAF NDA #050708SUPPL-50TACROLIMUSASTELLASLabelingApproval
June 11PROGRAF NDA #050709SUPPL-42TACROLIMUSASTELLASLabelingApproval
June 11ACTEMRA BLA #125276SUPPL-127TOCILIZUMABGENENTECH

Approval
June 11ACTEMRA BLA #125472SUPPL-40TOCILIZUMABGENENTECH

Approval
June 11QUETIAPINE FUMARATE ANDA #202939SUPPL-2QUETIAPINE FUMARATEINTELLIPHARMACEUTICSManufacturing (CMC)Approval
June 11ASTAGRAF XL NDA #204096SUPPL-7TACROLIMUSASTELLASLabelingApproval
June 11TESTOSTERONE ANDA #205328SUPPL-2TESTOSTERONEACTAVIS LABS UT INCREMSApproval
June 11TIGECYCLINE ANDA #206335ORIG-1TIGECYCLINEAUROBINDO PHARMA LTD

Approval
June 11POTASSIUM CHLORIDE ANDA #209026ORIG-1POTASSIUM CHLORIDEPRINSTON INC

Approval
June 11PROGRAF NDA #210115SUPPL-2TACROLIMUSASTELLASLabelingApproval
June 11HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #210663ORIG-1HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATEBRECKENRIDGE PHARM

Approval
June 12DIOVAN HCT NDA #020818SUPPL-75HYDROCHLOROTHIAZIDE; VALSARTANNOVARTISLabelingApproval
June 12DIOVAN NDA #021283SUPPL-53VALSARTANNOVARTISLabelingApproval
June 12EXFORGE NDA #021990SUPPL-33AMLODIPINE BESYLATE; VALSARTANNOVARTISLabelingApproval
June 12EXFORGE HCT NDA #022314SUPPL-27AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANNOVARTISLabelingApproval
June 12BUPROPION HYDROCHLORIDE ANDA #077284SUPPL-42BUPROPION HYDROCHLORIDEANCHEN PHARMSLabelingApproval
June 12MESALAMINE ANDA #202065ORIG-1MESALAMINESANDOZ INC

Approval
June 12PALIPERIDONE ANDA #204452ORIG-1PALIPERIDONEINVENTIA HLTHCARE

Approval
June 12LORATADINE ANDA #210033ORIG-1LORATADINEPERRIGO PHARMA INTL

Approval
June 12DAPAGLIFLOZIN ANDA #211545ORIG-1DAPAGLIFLOZINALKEM LABS LTD

Tentative Approval
June 12BUPRENORPHINE HYDROCHLORIDE ANDA #211594ORIG-1BUPRENORPHINE HYDROCHLORIDEALVOGEN MALTA

Tentative Approval
June 12VANCOMYCIN HYDROCHLORIDE ANDA #212332ORIG-1VANCOMYCIN HYDROCHLORIDEHAINAN POLY PHARM

Approval
June 13CLEOCIN HYDROCHLORIDE NDA

#050162

SUPPL-101CLINDAMYCIN HYDROCHLORIDEPHARMACIA AND UPJOHNLabelingApproval
June 13DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE ANDA #205295ORIG-1DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEFDC LTD

Approval
June 13NUZYRA NDA #209816SUPPL-2OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13NUZYRA NDA #209816SUPPL-3OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13NUZYRA NDA #209816SUPPL-4OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13NUZYRA NDA #209817SUPPL-1OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13NUZYRA NDA #209817SUPPL-2OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13NUZYRA NDA #209817SUPPL-3OMADACYCLINE TOSYLATEPARATEK PHARMS INCLabelingApproval
June 13BUDESONIDE NDA #211929ORIG-1BUDESONIDESUN PHARMA GLOBALType 5 - New Formulation or New ManufacturerApproval
June 13AMJEVITA BLA #761024SUPPL-4ADALIMUMAB-ATTOAMGEN INC

Approval
June 13KANJINTI BLA #761073ORIG-1TRASTUZUMAB-ANNSAMGEN INC

Approval
June 14LOTRISONE NDA #018827SUPPL-50BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLEMERCK SHARP DOHMELabelingApproval
June 14TRAMADOL HYDROCHLORIDE ANDA #202075SUPPL-2TRAMADOL HYDROCHLORIDEACI HEALTHCARE LTDREMSApproval
June 14APTENSIO XR NDA #205831SUPPL-5METHYLPHENIDATE

HYDROCHLORIDE

RHODES PHARMSEfficacyApproval
June 14DILTIAZEM HYDROCHLORIDE ANDA #208783ORIG-1DILTIAZEM HYDROCHLORIDENOVAST LABS

Approval
June 14OMEGA-3-ACID ETHYL ESTERS ANDA #210107ORIG-1OMEGA-3-ACID ETHYL ESTERSZYDUS

Approval
June 17CHILDREN'S CLARITIN NDA #021891SUPPL-31LORATADINEBAYER HEALTHCARE LLCLabelingApproval
June 17CLARITIN NDA #021891SUPPL-31LORATADINEBAYER HEALTHCARE LLCLabelingApproval
6/17/2019VICTOZA NDA #022341SUPPL-31LIRAGLUTIDE RECOMBINANTNOVO NORDISK INCEfficacyApproval
6/17/2019KEYTRUDA BLA #125514SUPPL-53PEMBROLIZUMABMERCK SHARP DOHME

Approval
6/17/2019SPINRAZA NDA #209531SUPPL-7NUSINERSEN SODIUMBIOGEN IDECLabelingApproval
6/17/2019SPINRAZA NDA #209531SUPPL-8NUSINERSEN SODIUMBIOGEN IDECLabelingApproval
6/17/2019POTASSIUM CHLORIDE ANDA #210097ORIG-1POTASSIUM CHLORIDEPII

Approval
June 18RAPAMUNE NDA #021083SUPPL-66SIROLIMUSPF PRISM CVLabelingApproval
June 18HALOPERIDOL DECANOATE ANDA #075305SUPPL-22HALOPERIDOL DECANOATEWEST-WARD PHARMS INTManufacturing (CMC)Approval
June 18INFLECTRA BLA #125544SUPPL-9INFLIXIMAB-DYYBCELLTRION INC

Approval
June 18ACETAZOLAMIDE ANDA #203917ORIG-1ACETAZOLAMIDEMYLAN

Approval
June 18ONZETRA XSAIL NDA #206099SUPPL-5SUMATRIPTAN SUCCINATEAVANIR PHARMSLabelingApproval
June 18DICLOFENAC SODIUM ANDA #208786ORIG-1DICLOFENAC SODIUMMYLAN LABS LTD

Approval
June 18BIKTARVY NDA #210251SUPPL-5BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATEGILEAD SCIENCES INCEfficacyApproval
June 18XERAVA NDA #211109SUPPL-1ERAVACYCLINE DIHYDROCHLORIDETETRAPHASE PHARMSManufacturing (CMC)Approval
June 19QUALAQUIN NDA #021799SUPPL-29QUININE SULFATESUN PHARM INDUSTRIESLabelingApproval
June 19CLEOCIN PHOSPHATE NDA #050441SUPPL-81CLINDAMYCIN PHOSPHATEPHARMACIA AND UPJOHNLabelingApproval
June 19CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #050639SUPPL-40CLINDAMYCIN PHOSPHATEPHARMACIA AND UPJOHNLabelingApproval
June 19SCOPOLAMINE ANDA #203753ORIG-1SCOPOLAMINEMYLAN TECHNOLOGIES

Approval
June 19MYCOPHENOLATE MOFETIL ANDA #204077SUPPL-1MYCOPHENOLATE MOFETILZHEJIANG HISUN PHARMManufacturing (CMC)Approval
June 19OTREXUP NDA #204824SUPPL-9METHOTREXATEANTARES PHARMA INCLabelingApproval
June 19OTREXUP PFS NDA #204824SUPPL-9METHOTREXATEANTARES PHARMA INCLabelingApproval
June 19BIMATOPROST ANDA #207601ORIG-1BIMATOPROSTSOMERSET THERAPS LLC

Approval
June 19LUBIPROSTONE ANDA #209450ORIG-1LUBIPROSTONEAMNEAL PHARMS NY

Tentative Approval
June 19IVERMECTIN ANDA #210225ORIG-1IVERMECTINPERRIGO UK FINCO

Tentative Approval
June 19CLINDAMYCIN PHOSPHATE ANDA

#210778

ORIG-1CLINDAMYCIN PHOSPHATEGLENMARK PHARMS LTD

Tentative Approval
June 20POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER NDA #019904SUPPL-20POTASSIUM CHLORIDEBAXTER HLTHCARELabelingApproval
June 20POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER NDA #019904SUPPL-20POTASSIUM CHLORIDEBAXTER HLTHCARELabelingApproval
June 20POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER NDA #019904SUPPL-20POTASSIUM CHLORIDEBAXTER HLTHCARELabelingApproval
June 20POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER NDA #019904SUPPL-20POTASSIUM CHLORIDEBAXTER HLTHCARELabelingApproval
June 20TRISENOX NDA #021248SUPPL-18ARSENIC TRIOXIDECEPHALONLabelingApproval
June 20BOTOX BLA #103000SUPPL-5309OnabotulinumtoxinAALLERGAN

Approval
June 20BOTOX COSMETIC BLA #103000SUPPL-5309OnabotulinumtoxinAALLERGAN

Approval
June 20AVASTIN BLA #125085SUPPL-331BEVACIZUMABGENENTECH

Approval
June 20KETOROLAC TROMETHAMINE ANDA #203492ORIG-1KETOROLAC TROMETHAMINEMICRO LABS LTD INDIA

Tentative Approval
June 20MYXREDLIN NDA #208157ORIG-1INSULIN HUMAN; SODIUM CHLORIDECELERITY PHARMSType 5 - New Formulation or New ManufacturerApproval
June 20DEXTENZA NDA #208742SUPPL-1DEXAMETHASONEOCULAR THERAPEUTIXEfficacyApproval
June 20SODIUM BICARBONATE ANDA #211091ORIG-1SODIUM BICARBONATEEXELA PHARMA SCS LLC

Approval
June 20GANCICLOVIR SODIUM ANDA #212001ORIG-1GANCICLOVIR SODIUMCUSTOPHARM INC

Approval
June 21COLAZAL NDA #020610SUPPL-21BALSALAZIDE DISODIUMVALEANT PHARMS INTLLabelingApproval
June 21TESTOSTERONE ANDA #091073SUPPL-2TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
June 21GEMCITABINE HYDROCHLORIDE NDA #200795SUPPL-10GEMCITABINE HYDROCHLORIDEHOSPIRA INCLabelingApproval
June 21DOCETAXEL NDA #201195SUPPL-13DOCETAXELACCORD HLTHCARELabelingApproval
June 21TESTOSTERONE ANDA #204571SUPPL-3TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
June 21TESTOSTERONE ANDA #204571SUPPL-5TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
June 21CAPECITABINE ANDA #204668ORIG-1CAPECITABINESUN PHARM

Approval
June 21DEXTROAMPHETAMINE SULFATE ANDA #205077ORIG-1DEXTROAMPHETAMINE SULFATEPII

Approval
June 21LINEZOLID ANDA #205442SUPPL-1LINEZOLIDHOSPIRA INCLabelingApproval
June 21LINEZOLID ANDA #205442SUPPL-2LINEZOLIDHOSPIRA INCLabelingApproval
June 21TESTOSTERONE ANDA #207373SUPPL-1TESTOSTERONEAMNEAL PHARMS LLCLabelingApproval
June 21MESALAMINE ANDA #208362ORIG-1MESALAMINEAMRING PHARMS

Approval
June 21SYMDEKO (COPACKAGED) NDA #210491SUPPL-3IVACAFTOR; IVACAFTOR,

TEZACAFTOR

VERTEX PHARMS INCEfficacyApproval
June 21VYLEESI NDA #210557ORIG-1BREMELANOTIDE ACETATEAMAG PHARMS INCType 1 - New Molecular EntityApproval
June 21BROMFENAC SODIUM ANDA #210560ORIG-1BROMFENAC SODIUMALEMBIC PHARMS LTD

Approval
June 21ROFLUMILAST ANDA #212490ORIG-1ROFLUMILASTALKEM LABS LTD

Tentative Approval
June 24TOPOTECAN HYDROCHLORIDE NDA #022453SUPPL-11TOPOTECAN HYDROCHLORIDETEVA PHARMS USALabelingApproval
June 24SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA #091348SUPPL-10SULFAMETHOXAZOLE;

TRIMETHOPRIM

AUROBINDO PHARMAManufacturing (CMC)Approval
June 24LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #091629SUPPL-20HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMAUROBINDO PHARMALabelingApproval
June 24LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #201682SUPPL-6HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMIPCA LABS LTDLabelingApproval
June 24LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #202289SUPPL-12HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMMACLEODS PHARMS LTDLabelingApproval
June 24LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #204832SUPPL-3HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMUNICHEM LABS LTDLabelingApproval
June 24LONHALA MAGNAIR KIT NDA #208437SUPPL-3GLYCOPYRROLATESUNOVION RESPLabelingApproval
June 24PENICILLAMINE ANDA #210976ORIG-1PENICILLAMINEWATSON LABS INC

Approval
June 24OSELTAMIVIR PHOSPHATE ANDA #211823ORIG-1OSELTAMIVIR PHOSPHATEALEMBIC PHARMS LTD

Approval
June 24Apremilast ANDA #211878ORIG-1APREMILASTANNORA

Tentative Approval
June 24DAPTOMYCIN ANDA #211961ORIG-1DAPTOMYCINACCORD HLTHCARE

Approval
June 24MVASI BLA #761028SUPPL-4BEVACIZUMAB-AWWBAMGEN INC

Approval
June 25XALKORI NDA #202570SUPPL-28CRIZOTINIBPF PRISM CVLabelingApproval
June 25BORTEZOMIB ANDA #202963ORIG-1BORTEZOMIBDR REDDYS LABS LTD

Tentative Approval
June 25DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE ANDA #207523ORIG-1DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOMERSET THERAPS LLC

Approval
June 25GEMCITABINE HYDROCHLORIDE NDA #209604SUPPL-4GEMCITABINE HYDROCHLORIDEACCORD HLTHCARELabelingApproval
June 25SPRAVATO NDA #211243SUPPL-2ESKETAMINE HYDROCHLORIDEJANSSEN PHARMSREMSApproval
June 26ZAVESCA NDA #021348SUPPL-15MIGLUSTATACTELION PHARMS LTDLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #077665SUPPL-8CLOPIDOGREL BISULFATEMYLAN PHARMS INCLabelingApproval
June 26LINEZOLID ANDA #200222SUPPL-4LINEZOLIDTEVA PHARMSLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #202928SUPPL-8CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #202928SUPPL-9CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #202928SUPPL-11CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #202928SUPPL-14CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDLabelingApproval
June 26CLOPIDOGREL BISULFATE ANDA #202928SUPPL-15CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDLabelingApproval
June 26ATORVASTATIN CALCIUM ANDA #208478ORIG-1ATORVASTATIN CALCIUMPERRIGO R AND D

Tentative Approval
June 26DOXYCYCLINE HYCLATE ANDA #208818SUPPL-1DOXYCYCLINE HYCLATELUPIN LTDLabelingApproval
June 26MIRABEGRON ANDA #209485ORIG-1MIRABEGRONLUPIN LTD

Tentative Approval
June 26DAPSONE ANDA #210191ORIG-1DAPSONETARO PHARMS

Approval
June 26DOPTELET NDA #210238SUPPL-1AVATROMBOPAG MALEATEAKARX INCEfficacyApproval
June 26FEBUXOSTAT ANDA #210461ORIG-1FEBUXOSTATMSN LABORATORIES

Tentative Approval
June 26TOBRAMYCIN ANDA #210915ORIG-1TOBRAMYCINTEVA PHARMS USA

Approval
June 26DAPAGLIFLOZIN ANDA #211467ORIG-1DAPAGLIFLOZINMICRO LABS LTD

Tentative Approval
June 26SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA #212231ORIG-1SULFAMETHOXAZOLE;

TRIMETHOPRIM

SOMERSET THERAPS LLC

Approval
June 26DAPTOMYCIN ANDA #212513ORIG-1DAPTOMYCINBE PHARMS

Approval
June 26RENFLEXIS BLA #761054SUPPL-9INFLIXIMAB-ABDASAMSUNG BIOEPIS CO LTD

Approval
June 26DUPIXENT BLA #761055SUPPL-14DUPILUMABREGENERON PHARMACEUTICALS

Approval
June 27FLUDEOXYGLUCOSE F18 NDA #021870SUPPL-15FLUDEOXYGLUCOSE F-18FEINSTEINLabelingApproval
June 27SOLIRIS BLA #125166SUPPL-431ECULIZUMABALEXION PHARM

Approval
June 27TESTOSTERONE ANDA #204268SUPPL-4TESTOSTERONEPERRIGO ISRAELLabelingApproval
June 27LINEZOLID ANDA #205154SUPPL-1LINEZOLIDMYLAN LABS LTDLabelingApproval
June 27LINEZOLID ANDA #205154SUPPL-3LINEZOLIDMYLAN LABS LTDLabelingApproval
June 27TESTOSTERONE ANDA #205781SUPPL-4TESTOSTERONEPERRIGO UK FINCOLabelingApproval
June 27LINEZOLID ANDA #206917SUPPL-1LINEZOLIDAUROBINDO PHARMA LTDLabelingApproval
June 27EZETIMIBE AND SIMVASTATIN ANDA #208699ORIG-1EZETIMIBE; SIMVASTATINGLENMARK PHARMS LTD

Approval
June 27AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ANDA #211546ORIG-1AMPHETAMINE ASPARTATE;AMPHETAMINE SULFATE;DEXTROAMPHETAMINE SACCHARATE;DEXTROAMPHETAMINE SULFATESPECGX LLC

Tentative Approval
June 27ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #211610ORIG-1ACETAMINOPHEN; CODEINE PHOSPHATEWES PHARMA INC

Approval
June 27METHYLPREDNISOLONE ANDA #212262ORIG-1METHYLPREDNISOLONESUNGEN PHARMA

Approval
June 27DARZALEX BLA #761036SUPPL-20DARATUMUMABJANSSEN BIOTECH

Approval
June 27ZIRABEV BLA #761099ORIG-1BEVACIZUMAB-BVZRPFIZER INC

Approval
June 28ANTIVERT NDA #010721SUPPL-63MECLIZINE HYDROCHLORIDECASPER PHARMA LLCEfficacyApproval
June 28THIOLA NDA #019569SUPPL-6TIOPRONINMISSION PHARMALabelingApproval
June 28LEVAQUIN NDA #020634SUPPL-71LEVOFLOXACINJANSSEN PHARMSLabelingApproval
June 28ERY-TAB ANDA #062298SUPPL-72ERYTHROMYCINARBOR PHARMS LLCLabelingApproval
June 28MINOCYCLINE HYDROCHLORIDE ANDA #065485SUPPL-11MINOCYCLINE HYDROCHLORIDEBARR LABS INCLabelingApproval
June 28FLUCONAZOLE ANDA #077253SUPPL-14FLUCONAZOLEGLENMARK GENERICSLabelingApproval
June 28FLUCONAZOLE ANDA #077253SUPPL-16FLUCONAZOLEGLENMARK GENERICSLabelingApproval
June 28FLUCONAZOLE ANDA #077253SUPPL-17FLUCONAZOLEGLENMARK GENERICSLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #090041SUPPL-5MEMANTINE HYDROCHLORIDEAMNEAL PHARMSLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #090043SUPPL-6MEMANTINE HYDROCHLORIDEUPSHER SMITH LABSLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #090051SUPPL-2MEMANTINE HYDROCHLORIDELUPIN LTDLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #090244SUPPL-1MEMANTINE HYDROCHLORIDEAPOTEX INCLabelingApproval
June 28LANSOPRAZOLE ANDA #090331SUPPL-16LANSOPRAZOLESANDOZLabelingApproval
June 28LANSOPRAZOLE ANDA #090331SUPPL-18LANSOPRAZOLESANDOZLabelingApproval
June 28LANSOPRAZOLE ANDA #090331SUPPL-19LANSOPRAZOLESANDOZLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #090961SUPPL-1MEMANTINE HYDROCHLORIDECADILALabelingApproval
June 28LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #091264SUPPL-8LEVOCETIRIZINE DIHYDROCHLORIDEHETERO LABS LTD IIILabelingApproval
June 28LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #091264SUPPL-10LEVOCETIRIZINE DIHYDROCHLORIDEHETERO LABS LTD IIILabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #202840SUPPL-9MEMANTINE HYDROCHLORIDEMACLEODS PHARMS LTDLabelingApproval
June 28MEMANTINE HYDROCHLORIDE ANDA #203175SUPPL-4MEMANTINE HYDROCHLORIDEAUROBINDO PHARMA LTDLabelingApproval
June 28VORICONAZOLE ANDA #203503SUPPL-1VORICONAZOLEGLENMARK PHARMS LTDLabelingApproval
June 28VORICONAZOLE ANDA #203503SUPPL-2VORICONAZOLEGLENMARK PHARMS LTDLabelingApproval
June 28VORICONAZOLE ANDA #203503SUPPL-3VORICONAZOLEGLENMARK PHARMS LTDLabelingApproval
June 28TRANEXAMIC ACID ANDA #203521SUPPL-10TRANEXAMIC ACIDEMCURE PHARMS LTDLabelingApproval
June 28LINEZOLID ANDA #204696SUPPL-2LINEZOLIDSAGENT PHARMSLabelingApproval
June 28PEMETREXED ANDA #205238ORIG-1PEMETREXEDSUN PHARM INDS LTD

Tentative Approval
June 28MEMANTINE HYDROCHLORIDE ANDA #206855SUPPL-1MEMANTINE HYDROCHLORIDEPURACAP PHARM LLCLabelingApproval
June 28TRAMADOL HYDROCHLORIDE ANDA #208708ORIG-1TRAMADOL HYDROCHLORIDERUBICON

Approval
June 28CINACALCET HYDROCHLORIDE ANDA #210548ORIG-1CINACALCET HYDROCHLORIDELUPIN LTD

Approval
June 28CLONAZEPAM ANDA #211033ORIG-1CLONAZEPAMALEMBIC PHARMS LTD

Approval
June 28ISOPROTERENOL HYDROCHLORIDE ANDA #211738ORIG-1ISOPROTERENOL HYDROCHLORIDECIPLA

Approval
June 28THIOLA EC NDA #211843ORIG-1TIOPRONINMISSION PHARMACAL COType 3 - New Dosage FormApproval
June 28OGIVRI BLA #761074SUPPL-5TRASTUZUMAB-DKSTMYLAN GMBH

Approval
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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