Sunday, February 23, 2020

Sunday, February 23, 2020

FDA OK'd 481 drugs in May


The U.S. Food and Drug Administration approved 481 drug products in May, 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 May

Approval DateDrug NameSubmissionActive IngredientsCompanySubmission ClassificationSubmission Status
May 1DIPROLENE NDA #018741SUPPL-40BETAMETHASONE DIPROPIONATEMERCK SHARP DOHMELabelingApproval
May 1DIPROLENE AF NDA #019555SUPPL-35BETAMETHASONE DIPROPIONATEMERCK SHARP DOHMELabelingApproval
May 1DIPROLENE NDA #019716SUPPL-33BETAMETHASONE DIPROPIONATEMERCK SHARP DOHMELabelingApproval
May 1NORMOCARB HF 25 NDA #021910SUPPL-8MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDEDIALYSIS SUPSLabelingApproval
May 1NORMOCARB HF 35 NDA #021910SUPPL-8MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDEDIALYSIS SUPSLabelingApproval
May 1GEMCITABINE HYDROCHLORIDE ANDA #079160SUPPL-9GEMCITABINE HYDROCHLORIDEACTAVIS TOTOWALabelingApproval
May 1GEMCITABINE HYDROCHLORIDE ANDA #079160SUPPL-10GEMCITABINE HYDROCHLORIDEACTAVIS TOTOWALabelingApproval
May 1LAMIVUDINE ANDA #090198ORIG-1LAMIVUDINEMACLEODS PHARMS LTD

Approval
May 1GEMCITABINE HYDROCHLORIDE ANDA #091365SUPPL-7GEMCITABINE HYDROCHLORIDEDR REDDYS LABS LTDLabelingApproval
May 1BLISOVI 24 FE ANDA #091398SUPPL-1ETHINYL ESTRADIOL; NORETHINDRONE ACETATELUPIN LTDLabelingApproval
May 1BLISOVI 24 FE ANDA #091398SUPPL-5ETHINYL ESTRADIOL; NORETHINDRONE ACETATELUPIN LTDLabelingApproval
May 1BLISOVI 24 FE ANDA #091398SUPPL-9ETHINYL ESTRADIOL; NORETHINDRONE ACETATELUPIN LTDManufacturing (CMC)Approval
May 1XOLAIR BLA #103976SUPPL-5234OMALIZUMABGENENTECH

Approval
May 1NADOLOL ANDA #201893SUPPL-1NADOLOLAUROBINDO PHARMA LTDManufacturing (CMC)Approval
May 1DACTINOMYCIN ANDA #203385SUPPL-1DACTINOMYCINMYLAN LABS LTDLabelingApproval
May 1DAPTOMYCIN ANDA #208375ORIG-1DAPTOMYCINDR REDDYS

Approval
May 1MEDROXYPROGESTERONE ACETATE ANDA #210760ORIG-1MEDROXYPROGESTERONE ACETATESUN PHARM

Approval
May 1CALCIUM CHLORIDE 10% ANDA #211553ORIG-1CALCIUM CHLORIDEMEDEFIL INC

Approval
May 2ETOPOPHOS PRESERVATIVE FREE NDA #020457SUPPL-19ETOPOSIDE PHOSPHATEBRISTOL MYERS SQUIBBLabelingApproval
May 2TOPAMAX NDA #020505SUPPL-60TOPIRAMATEJANSSEN PHARMSLabelingApproval
May 2TOPAMAX NDA #020844SUPPL-51TOPIRAMATEJANSSEN PHARMSLabelingApproval
May 2TOPAMAX SPRINKLE NDA #020844SUPPL-51TOPIRAMATEJANSSEN PHARMSLabelingApproval
May 2REBETOL NDA #020903SUPPL-55RIBAVIRINMERCK SHARP DOHMELabelingApproval
May 2REBETOL NDA #021546SUPPL-11RIBAVIRINSCHERINGLabelingApproval
May 2KUVAN NDA #022181SUPPL-19SAPROPTERIN DIHYDROCHLORIDEBIOMARIN PHARMLabelingApproval
May 2PREDNISONE ANDA #088832SUPPL-35PREDNISONEMYLANManufacturing (CMC)Approval
May 2OPDIVO BLA #125554SUPPL-73NIVOLUMABBRISTOL MYERS SQUIBB

Approval
May 2BLISOVI FE 1.5/30 ANDA #201585SUPPL-5ETHINYL ESTRADIOL; NORETHINDRONE ACETATELUPIN LTDLabelingApproval
May 2BLISOVI FE 1.5/30 ANDA #201585SUPPL-8ETHINYL ESTRADIOL; NORETHINDRONE ACETATELUPIN LTDManufacturing (CMC)Approval
May 2KUVAN NDA #205065SUPPL-5SAPROPTERIN DIHYDROCHLORIDEBIOMARIN PHARMLabelingApproval
May 2TIMOLOL MALEATE ANDA #207556ORIG-1TIMOLOL MALEATEINVATECH PHARMA

Approval
May 2LEVONORGESTREL ANDA #207660ORIG-1LEVONORGESTRELACCORD HLTHCARE

Approval
May 2QTERN NDA #209091SUPPL-2DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDEASTRAZENECA ABEfficacyApproval
May 2QTERNMET XR NDA #210874ORIG-1DAPAGLIFLOZIN;SAXAGLIPTIN;METFORMIN HYDROCHLORIDEASTRAZENECA ABType 4 - New CombinationApproval
May 2TIBSOVO NDA #211192SUPPL-1IVOSIDENIBAGIOS PHARMS INCEfficacyApproval
May 3FELDENE NDA #018147SUPPL-48PIROXICAMPFIZERLabelingApproval
May 3DAYPRO NDA #018841SUPPL-30OXAPROZINGD SEARLELabelingApproval
May 3CIPRO NDA #019537SUPPL-89CIPROFLOXACIN HYDROCHLORIDEBAYER HLTHCARELabelingApproval
May 3CIPRO NDA #019847SUPPL-60CIPROFLOXACINBAYER HLTHCARELabelingApproval
May 3CIPRO IN DEXTROSE 5% IN

PLASTIC CONTAINER NDA #019857

SUPPL-69CIPROFLOXACINBAYER HLTHCARELabelingApproval
May 3LEVAQUIN NDA #020634SUPPL-72LEVOFLOXACINJANSSEN PHARMSLabelingApproval
May 3DAYPRO ALTA NDA #020776SUPPL-8OXAPROZIN POTASSIUMGD SEARLELabelingApproval
May 3CIPRO NDA #020780SUPPL-46CIPROFLOXACINBAYER HLTHCARELabelingApproval
May 3CELEBREX NDA #020998SUPPL-54CELECOXIBGD SEARLELabelingApproval
May 3AVELOX NDA #021085SUPPL-65MOXIFLOXACIN HYDROCHLORIDEBAYER HLTHCARELabelingApproval
May 3FACTIVE NDA #021158SUPPL-26GEMIFLOXACIN MESYLATELG CHEM LTDLabelingApproval
May 3AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDA #021277SUPPL-61MOXIFLOXACIN HYDROCHLORIDEBAYER HLTHCARELabelingApproval
May 3CIPRO XR NDA #021473SUPPL-40CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEBAYER HLTHCARELabelingApproval
May 3VANCOMYCIN HYDROCHLORIDE ANDA #065490SUPPL-10VANCOMYCIN HYDROCHLORIDESTRIDES PHARMAManufacturing (CMC)Approval
May 3LEVOFLOXACIN ANDA #076276SUPPL-8LEVOFLOXACINMYLANLabelingApproval
May 3LEVOFLOXACIN ANDA #076361SUPPL-13LEVOFLOXACINTEVALabelingApproval
May 3LEVOFLOXACIN ANDA #076710SUPPL-14LEVOFLOXACINDR REDDYS LABS INCLabelingApproval
May 3CIPROFLOXACIN ANDA #076717SUPPL-7CIPROFLOXACINHIKMA FARMACEUTICALabelingApproval
May 3CIPROFLOXACIN IN DEXTROSE 5% ANDA #076757SUPPL-9CIPROFLOXACINHIKMA FARMACEUTICALabelingApproval
May 3LEVOFLOXACIN ANDA #077097SUPPL-8LEVOFLOXACINMYLANLabelingApproval
May 3OFLOXACIN ANDA #077098SUPPL-12OFLOXACINDR REDDYS LABS LTDLabelingApproval
May 3CIPROFLOXACIN ANDA #077245SUPPL-23CIPROFLOXACINHOSPIRALabelingApproval
May 3LEVOFLOXACIN ANDA #077438SUPPL-17LEVOFLOXACINSANDOZLabelingApproval
May 3LEVOFLOXACIN ANDA #077652SUPPL-16LEVOFLOXACINZYDUS PHARMS USA INCLabelingApproval
May 3CIPROFLOXACIN EXTENDED RELEASE ANDA #077701SUPPL-15CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEDR REDDYS LABS LTDLabelingApproval
May 3CIPROFLOXACIN EXTENDED RELEASE ANDA #077701SUPPL-16CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEDR REDDYS LABS LTDLabelingApproval
May 3CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #077753SUPPL-20CIPROFLOXACINHOSPIRALabelingApproval
May 3CIPROFLOXACIN EXTENDED RELEASE ANDA #078166SUPPL-14CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEANCHEN PHARMSLabelingApproval
May 3CIPROFLOXACIN EXTENDED RELEASE ANDA #078183SUPPL-21CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEMYLAN PHARMS INCLabelingApproval
May 3CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252SUPPL-32CIPROFLOXACININFORLIFELabelingApproval
May 3LEVOFLOXACIN ANDA #078424SUPPL-18LEVOFLOXACINLUPINLabelingApproval
May 3CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078431SUPPL-10CIPROFLOXACINHIKMA FARMACEUTICALabelingApproval
May 3LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078579SUPPL-6LEVOFLOXACINHOSPIRA INCLabelingApproval
May 3CIPROFLOXACIN EXTENDED RELEASE ANDA #078712SUPPL-6CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEFOSUN PHARMALabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #078759SUPPL-3GEMCITABINE HYDROCHLORIDECIPLALabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #078759SUPPL-4GEMCITABINE HYDROCHLORIDECIPLALabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #078759SUPPL-5GEMCITABINE HYDROCHLORIDECIPLALabelingApproval
May 3ROCURONIUM BROMIDE ANDA #079195SUPPL-17ROCURONIUM BROMIDESANDOZ INCLabelingApproval
May 3OGEN .625 ANDA #083220SUPPL-44ESTROPIPATEPHARMACIA AND UPJOHNLabelingApproval
May 3OGEN 1.25 ANDA #083220SUPPL-44ESTROPIPATEPHARMACIA AND UPJOHNLabelingApproval
May 3OGEN 2.5 ANDA #083220SUPPL-44ESTROPIPATEPHARMACIA AND UPJOHNLabelingApproval
May 3OGEN 5 ANDA #083220SUPPL-44ESTROPIPATEPHARMACIA AND UPJOHNLabelingApproval
May 3DEPO-ESTRADIOL ANDA #085470SUPPL-23ESTRADIOL CYPIONATEPHARMACIA AND UPJOHNLabelingApproval
May 3LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343SUPPL-27LEVOFLOXACININFORLIFELabelingApproval
May 3LEVOFLOXACIN ANDA #090367SUPPL-4LEVOFLOXACINWOCKHARDTLabelingApproval
May 3LEVOFLOXACIN ANDA #090722SUPPL-14LEVOFLOXACINTORRENT PHARMSLabelingApproval
May 3LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375SUPPL-15LEVOFLOXACINHIKMA FARMACEUTICALabelingApproval
May 3KADCYLA BLA #125427SUPPL-105ADO-TRASTUZUMAB EMTANSINEGENENTECH

Approval
May 3GEMCITABINE HYDROCHLORIDE ANDA #200145SUPPL-10GEMCITABINE HYDROCHLORIDEMYLAN LABS LTDLabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #200145SUPPL-11GEMCITABINE HYDROCHLORIDEMYLAN LABS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #200250SUPPL-4LEVOFLOXACINGLENMARK GENERICSLabelingApproval
May 3LEVOFLOXACIN ANDA #200560SUPPL-13LEVOFLOXACINMYLAN ASILabelingApproval
May 3LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #200674SUPPL-8LEVOFLOXACINFRESENIUS KABI USALabelingApproval
May 3LEVOFLOXACIN ANDA #200839SUPPL-12LEVOFLOXACINMACLEODS PHARMS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #200839SUPPL-13LEVOFLOXACINMACLEODS PHARMS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #200839SUPPL-17LEVOFLOXACINMACLEODS PHARMS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #200839SUPPL-18LEVOFLOXACINMACLEODS PHARMS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #200839SUPPL-19LEVOFLOXACINMACLEODS PHARMS LTDLabelingApproval
May 3METOPROLOL TARTRATE ANDA #200981SUPPL-14METOPROLOL TARTRATERUBICONLabelingApproval
May 3LEVOFLOXACIN ANDA #202200SUPPL-8LEVOFLOXACINORCHID HLTHCARELabelingApproval
May 3LEVOFLOXACIN ANDA #202328SUPPL-10LEVOFLOXACINAUROBINDO PHARMA LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #202590SUPPL-10LEVOFLOXACINEMCURE PHARMS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #202801SUPPL-5LEVOFLOXACINHETERO LABS LTD VLabelingApproval
May 3OMEPRAZOLE ANDA #203270SUPPL-10OMEPRAZOLEAUROBINDO PHARMA LTDManufacturing (CMC)Approval
May 3LEVOFLOXACIN ANDA #203613SUPPL-4LEVOFLOXACINJUBILANT GENERICSLabelingApproval
May 3GANIRELIX ACETATE

ANDA #204246

SUPPL-1GANIRELIX ACETATESUN PHARMLabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #204549SUPPL-2GEMCITABINE HYDROCHLORIDEACTAVIS INCLabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #205242SUPPL-1GEMCITABINE HYDROCHLORIDEMYLAN LABS LTDLabelingApproval
May 3TRIUMEQ NDA #205551SUPPL-16ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINEVIIV HLTHCARELabelingApproval
May 3MOXIFLOXACIN HYDROCHLORIDE NDA #205572SUPPL-6MOXIFLOXACIN HYDROCHLORIDEFRESENIUS KABI USALabelingApproval
May 3MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

ANDA #205833

SUPPL-5MOXIFLOXACIN HYDROCHLORIDEMYLAN LABS LTDLabelingApproval
May 3LEVOFLOXACIN ANDA #205968SUPPL-3LEVOFLOXACINZYDUS PHARMSLabelingApproval
May 3ROCURONIUM BROMIDE ANDA #206206SUPPL-3ROCURONIUM BROMIDEAUROBINDO PHARMA LTDLabelingApproval
May 3QUETIAPINE FUMARATE ANDA #206260SUPPL-2QUETIAPINE FUMARATEPHARMADAX INCLabelingApproval
May 3GEMCITABINE HYDROCHLORIDE ANDA #206776SUPPL-2GEMCITABINE HYDROCHLORIDEAPOTEX INCLabelingApproval
May 3LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #206919SUPPL-5LEVOFLOXACINAUROBINDO PHARMA LTDLabelingApproval
May 3MELPHALAN HYDROCHLORIDE ANDA #207032ORIG-1MELPHALAN HYDROCHLORIDEUS WORLDMEDS LLC

Approval
May 3BAXDELA NDA #208610SUPPL-6DELAFLOXACIN MEGLUMINEMELINTALabelingApproval
May 3BAXDELA NDA #208611SUPPL-5DELAFLOXACIN MEGLUMINEMELINTALabelingApproval
May 3FENTANYL CITRATE

PRESERVATIVE FREE

ANDA #210762

ORIG-1FENTANYL CITRATEFRESENIUS KABI USA

Approval
May 3VYNDAQEL NDA #211996ORIG-1TAFAMIDIS MEGLUMINEFOLDRX PHARMACEUTICALS INCType 1 - New Molecular EntityApproval
May 3VYNDAMAX NDA #212161ORIG-1TAFAMIDISFOLDRX PHARMACEUTICALS INCType 2 - New Active IngredientApproval
May 3FUROSEMIDE ANDA #212174ORIG-1FUROSEMIDEAUROBINDO PHARMA LTD

Approval
May 6SORILUX NDA #022563SUPPL-6CALCIPOTRIENEMAYNE PHARMAEfficacyApproval
May 6CIPROFLOXACIN EXTENDED RELEASE ANDA #077417SUPPL-8CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEACTAVIS LABS FL INCLabelingApproval
May 6CIPROFLOXACIN EXTENDED RELEASE ANDA #077809SUPPL-8CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDEACTAVIS LABS FL INCLabelingApproval
May 6CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024SUPPL-29CIPROFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024SUPPL-30CIPROFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6CIPROFLOXACIN ANDA #078062SUPPL-17CIPROFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6CIPROFLOXACIN ANDA #078062SUPPL-18CIPROFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6TYLENOL W/ CODEINE NO. 1 ANDA #085055SUPPL-56ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 1 ANDA #085055SUPPL-62ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 2 ANDA #085055SUPPL-56ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 2 ANDA #085055SUPPL-62ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 3 ANDA #085055SUPPL-56ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 3 ANDA #085055SUPPL-62ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 4 ANDA #085055SUPPL-56ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6TYLENOL W/ CODEINE NO. 4 ANDA #085055SUPPL-62ACETAMINOPHEN; CODEINE PHOSPHATEJANSSEN PHARMSLabelingApproval
May 6LEVOFLOXACIN ANDA #090787SUPPL-10LEVOFLOXACINAPOTEX INCLabelingApproval
May 6LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397SUPPL-18LEVOFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397SUPPL-19LEVOFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6LEVOFLOXACIN ANDA #091436SUPPL-9LEVOFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6LEVOFLOXACIN ANDA #091436SUPPL-10LEVOFLOXACINBAXTER HLTHCARE CORPLabelingApproval
May 6ENTYVIO BLA #125476SUPPL-27VEDOLIZUMABTAKEDA PHARMS USA

Approval
May 6LEVOFLOXACIN ANDA #201043SUPPL-18LEVOFLOXACINAUROBINDO PHARMA LTDLabelingApproval
May 6DICLOFENAC SODIUM ANDA #204306ORIG-1DICLOFENAC SODIUMMYLAN

Approval
May 6LITHIUM CARBONATE

ANDA #205532

SUPPL-2LITHIUM CARBONATEHERITAGE PHARMAManufacturing (CMC)Approval
May 6RUZURGI NDA #209321ORIG-1AMIFAMPRIDINEJACOBUS PHARMACEUTICAL CO INCType 2 - New Active IngredientApproval
May 6RUZURGI NDA #209321ORIG-2AMIFAMPRIDINEJACOBUS PHARMACEUTICAL CO INCType 2 - New Active IngredientTentative Approval
May 6ARSENIC TRIOXIDE ANDA #209873ORIG-1ARSENIC TRIOXIDESTI PHARMA LLC

Approval
May 6COLESEVELAM HYDROCHLORIDE ANDA #210316ORIG-1COLESEVELAM HYDROCHLORIDEALKEM LABS LTD

Approval
May 6FOSAPREPITANT DIMEGLUMINE ANDA #210689ORIG-1FOSAPREPITANT DIMEGLUMINELUPIN LTD

Tentative Approval
May 6ONPATTRO NDA #210922SUPPL-1PATISIRAN SODIUMALNYLAM PHARMS INCLabelingApproval
May 6POTASSIUM CHLORIDE ANDA #212183ORIG-1POTASSIUM CHLORIDEBELCHER PHARMS LLC

Approval
May 6TECENTRIQ BLA #761034SUPPL-13ATEZOLIZUMABGENENTECH INC

Approval
May 6TECENTRIQ BLA #761034SUPPL-14ATEZOLIZUMABGENENTECH INC

Approval
May 7NAVELBINE NDA #020388SUPPL-36VINORELBINE TARTRATEPIERRE FABRELabelingApproval
May 7CLARITIN HIVES RELIEF REDITAB NDA #020704SUPPL-35LORATADINEBAYER HEALTHCARE LLCLabelingApproval
May 7CLARITIN REDITABS NDA #020704SUPPL-35LORATADINEBAYER HEALTHCARE LLCLabelingApproval
May 7SUTENT NDA #021938SUPPL-36SUNITINIB MALATECPPI CVEfficacyApproval
May 7LEVOFLOXACIN ANDA #076890SUPPL-15LEVOFLOXACINCIPLA LTDLabelingApproval
May 7TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351SUPPL-2HYDROCHLOROTHIAZIDE; TELMISARTANLUPIN LTDLabelingApproval
May 7TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351SUPPL-4HYDROCHLOROTHIAZIDE; TELMISARTANLUPIN LTDLabelingApproval
May 7LOSARTAN POTASSIUM ANDA #091541SUPPL-12LOSARTAN POTASSIUMMICRO LABSLabelingApproval
May 7ENTYVIO BLA #125476SUPPL-24VEDOLIZUMABTAKEDA PHARMS USA

Approval
May 7TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #201192SUPPL-6HYDROCHLOROTHIAZIDE; TELMISARTANTORRENTLabelingApproval
May 7TELMISARTAN AND AMLODIPINE ANDA #201586SUPPL-6AMLODIPINE BESYLATE; TELMISARTANLUPIN LTDLabelingApproval
May 7LOSARTAN POTASSIUM ANDA #203030SUPPL-4LOSARTAN POTASSIUMUNICHEM LABS LTDLabelingApproval
May 7DESVENLAFAXINE SUCCINATE ANDA #204805ORIG-1DESVENLAFAXINE SUCCINATEINTELLIPHARMACEUTICS

Approval
May 7POTASSIUM CHLORIDE NDA #206814SUPPL-8POTASSIUM CHLORIDEGENUS LIFESCIENCESManufacturing (CMC)Approval
May 7ROSUVASTATIN CALCIUM ANDA #207375ORIG-1ROSUVASTATIN CALCIUMSHANDONG

Approval
May 7PENICILLAMINE ANDA #209921ORIG-1PENICILLAMINEAMERIGEN PHARMS LTD

Approval
May 7BUSULFAN ANDA #210448ORIG-1BUSULFANAPOTEX INC

Approval
May 8DECADRON NDA #011664SUPPL-64DEXAMETHASONEMERCKLabelingApproval
May 8LO/OVRAL-28 NDA #017802SUPPL-34ETHINYL ESTRADIOL; NORGESTRELWYETH PHARMSLabelingApproval
May 8NORMINEST FE NDA #017948SUPPL-46ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATEGD SEARLE LLCLabelingApproval
May 8NORQUEST FE NDA #018926SUPPL-13ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONEGD SEARLE LLCLabelingApproval
May 8TRIPHASIL-28 NDA #019190SUPPL-49ETHINYL ESTRADIOL; LEVONORGESTRELWYETH PHARMS INCLabelingApproval
May 8TRIPHASIL-21 NDA #019192SUPPL-48ETHINYL ESTRADIOL; LEVONORGESTRELWYETH PHARMSLabelingApproval
May 8NUVARING NDA #021187SUPPL-37ETHINYL ESTRADIOL; ETONOGESTRELORGANON SUB MERCKLabelingApproval
May 8OMNARIS NDA #022004SUPPL-18CICLESONIDECOVIS PHARMA BVLabelingApproval
May 8BETHANECHOL CHLORIDE ANDA #040725SUPPL-2BETHANECHOL CHLORIDEECI PHARMS LLCManufacturing (CMC)Approval
May 8BETHANECHOL CHLORIDE ANDA #040726SUPPL-2BETHANECHOL CHLORIDEECI PHARMS LLCManufacturing (CMC)Approval
May 8BETHANECHOL CHLORIDE ANDA #040727SUPPL-2BETHANECHOL CHLORIDEECI PHARMS LLCManufacturing (CMC)Approval
May 8BETHANECHOL CHLORIDE ANDA #040728SUPPL-2BETHANECHOL CHLORIDEECI PHARMS LLCManufacturing (CMC)Approval
May 8PROLIA BLA #125320SUPPL-196DENOSUMABAMGEN

Approval
May 8PROLIA BLA #125320SUPPL-199DENOSUMABAMGEN

Approval
May 8XGEVA BLA #125320SUPPL-196DENOSUMABAMGEN

Approval
May 8XGEVA BLA #125320SUPPL-199DENOSUMABAMGEN

Approval
May 8YERVOY BLA #125377SUPPL-102IPILIMUMABBRISTOL MYERS SQUIBB

Approval
May 8ESZOPICLONE ANDA #203087ORIG-1ESZOPICLONEBRECKENRIDGE PHARM

Approval
May 8BUSULFAN ANDA #207050SUPPL-1BUSULFANPHARMASCIENCE INCLabelingApproval
May 8BUSULFAN ANDA #207050SUPPL-2BUSULFANPHARMASCIENCE INCLabelingApproval
May 8DAPSONE ANDA #207165ORIG-1DAPSONESAI LIFE SCIENCES

Approval
May 9CREON NDA #020725SUPPL-25PANCRELIPASE (AMYLASE; LIPASE; PROTEASE)ABBVIELabelingApproval
May 9LANTUS NDA #021081SUPPL-72INSULIN GLARGINE RECOMBINANTSANOFI AVENTIS USLabelingApproval
May 9LANTUS SOLOSTAR NDA #021081SUPPL-72INSULIN GLARGINE RECOMBINANTSANOFI AVENTIS USLabelingApproval
May 9ARMODAFINIL ANDA #200043ORIG-2ARMODAFINILMYLAN PHARMS INC

Approval
May 9MESALAMINE ANDA #207873ORIG-1MESALAMINETEVA PHARMS USA

Approval
May 9LACOSAMIDE ANDA #209301ORIG-1LACOSAMIDEHETERO LABS UNIT III

Tentative Approval
May 9HYDROXYPROGESTERONE CAPROATE ANDA #211142ORIG-1HYDROXYPROGESTERONE CAPROATEEUGIA PHARMA

Approval
May 9SPRAVATO NDA #211243SUPPL-1ESKETAMINE HYDROCHLORIDEJANSSEN PHARMSLabelingApproval
May 10ANAFRANIL NDA #019906SUPPL-43CLOMIPRAMINE HYDROCHLORIDESPECGX LLCLabelingApproval
May 10 EPIVIR NDA #020564SUPPL-39LAMIVUDINEVIIV HLTHCARELabelingApproval
May 10EPIVIR NDA #020596SUPPL-38LAMIVUDINEVIIV HLTHCARELabelingApproval
May 10COMBIVIR NDA #020857SUPPL-34LAMIVUDINE; ZIDOVUDINEVIIV HLTHCARELabelingApproval
May 10ANDROGEL NDA #021015SUPPL-45TESTOSTERONEABBVIELabelingApproval
May 10TRIZIVIR NDA #021205SUPPL-38ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINEVIIV HLTHCARELabelingApproval
May 10TESTIM NDA #021454SUPPL-27TESTOSTERONEAUXILIUM PHARMS LLCLabelingApproval
May 10FORTESTA NDA #021463SUPPL-20TESTOSTERONEENDO PHARMSLabelingApproval
May 10CADUET NDA #021540SUPPL-44AMLODIPINE BESYLATE; ATORVASTATIN CALCIUMPFIZERLabelingApproval
May 10EPZICOM NDA #021652SUPPL-24ABACAVIR SULFATE; LAMIVUDINEVIIV HLTHCARELabelingApproval
May 10ANDROGEL NDA #022309SUPPL-20TESTOSTERONEABBVIELabelingApproval
May 10ZOSYN NDA #050684SUPPL-94PIPERACILLIN SODIUM; TAZOBACTAM SODIUMWYETH PHARMSLabelingApproval
May 10ZOSYN IN PLASTIC CONTAINER

NDA #050750

SUPPL-41PIPERACILLIN SODIUM; TAZOBACTAM SODIUMWYETH PHARMSLabelingApproval
May 10LANSOPRAZOLE ANDA #091269SUPPL-8LANSOPRAZOLEDR REDDYS LABS LTDLabelingApproval
May 10LANSOPRAZOLE ANDA #091269SUPPL-12LANSOPRAZOLEDR REDDYS LABS LTDLabelingApproval
May 10LANSOPRAZOLE ANDA #091269SUPPL-13LANSOPRAZOLEDR REDDYS LABS LTDLabelingApproval
May 10LANSOPRAZOLE ANDA #091269SUPPL-14LANSOPRAZOLEDR REDDYS LABS LTDLabelingApproval
May 10LANSOPRAZOLE ANDA #091269SUPPL-16LANSOPRAZOLEDR REDDYS LABS LTDLabelingApproval
May 10Xeomin BLA #125360SUPPL-74incobotulinumtoxinAMERZ PHARMS

Approval
May 10CYRAMZA BLA #125477SUPPL-29RAMUCIRUMABELI LILLY AND CO

Approval
May 10LANSOPRAZOLE ANDA #202176SUPPL-7LANSOPRAZOLEWOCKHARDT USALabelingApproval
May 10LANSOPRAZOLE ANDA #202176SUPPL-8LANSOPRAZOLEWOCKHARDT USALabelingApproval
May 10TESTOSTERONE ANDA #204255SUPPL-4TESTOSTERONEPERRIGO ISRAELLabelingApproval
May 10VOGELXO NDA #204399SUPPL-10TESTOSTERONEUPSHER SMITH LABSLabelingApproval
May 10TESTOSTERONE ANDA #205328SUPPL-1TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
May 10SAPROPTERIN DIHYDROCHLORIDE ANDA #207200ORIG-1SAPROPTERIN DIHYDROCHLORIDEPAR PHARM INC

Approval
May 10NUPLAZID NDA #207318SUPPL-7PIMAVANSERIN TARTRATEACADIA PHARMS INCLabelingApproval
May 10CHLORTHALIDONE ANDA #207813ORIG-1CHLORTHALIDONEZYDUS PHARMS

Approval
May 10TESTOSTERONE ANDA #208061SUPPL-1TESTOSTERONELUPIN LTDLabelingApproval
May 10NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE ANDA #208499ORIG-1DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUMPERRIGO R AND D

Approval
May 10ESOMEPRAZOLE MAGNESIUM ANDA #209495ORIG-1ESOMEPRAZOLE MAGNESIUMGLENMARK PHARMS

Approval
May 10TESTOSTERONE ANDA #209533SUPPL-3TESTOSTERONECIPLALabelingApproval
May 10NUPLAZID NDA #210793SUPPL-2PIMAVANSERIN TARTRATEACADIA PHARMS INCLabelingApproval
May 10DEXAMETHASONE SODIUM PHOSPHATE ANDA #211036ORIG-1DEXAMETHASONE SODIUM PHOSPHATESOMERSET THERAPS LLC

Approval
May 10OXYBUTYNIN CHLORIDE ANDA #211682ORIG-1OXYBUTYNIN CHLORIDEEMCURE PHARMS LTD

Approval
May 13ALEVE NDA #020204SUPPL-63NAPROXEN SODIUMBAYERLabelingApproval
May 13ALEVE NDA #020204SUPPL-64NAPROXEN SODIUMBAYERLabelingApproval
May 13ALEVE NDA #020204SUPPL-65NAPROXEN SODIUMBAYERLabelingApproval
May 13EYLEA BLA #125387SUPPL-61AFLIBERCEPTREGENERON PHARMACEUTICALS

Approval
May 13ENTECAVIR ANDA #202122SUPPL-3ENTECAVIRTEVA PHARMS USALabelingApproval
May 13ENTECAVIR ANDA #202122SUPPL-5ENTECAVIRTEVA PHARMS USALabelingApproval
May 13ENTECAVIR ANDA #202122SUPPL-7ENTECAVIRTEVA PHARMS USALabelingApproval
May 13ODOMZO NDA #205266SUPPL-6SONIDEGIB PHOSPHATESUN PHARMA GLOBALLabelingApproval
May 13RISEDRONATE SODIUM ANDA #205280ORIG-1RISEDRONATE SODIUMORCHID HLTHCARE

Approval
May 13DOXORUBICIN HYDROCHLORIDE ANDA #206062ORIG-1DOXORUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOU

Approval
May 13CORLANOR NDA #206143SUPPL-7IVABRADINE HYDROCHLORIDEAMGEN INCLabelingApproval
May 13ENTECAVIR ANDA #206872SUPPL-2ENTECAVIRCIPLALabelingApproval
May 13ENTECAVIR ANDA #206872SUPPL-3ENTECAVIRCIPLALabelingApproval
May 13ENTECAVIR ANDA #208721SUPPL-1ENTECAVIRBRECKENRIDGE PHARMLabelingApproval
May 13FENOFIBRATE (MICRONIZED)

ANDA #209504

SUPPL-2FENOFIBRATEAMERIGEN PHARMS LTDLabelingApproval
May 13LABETALOL HYDROCHLORIDE ANDA #211325ORIG-1LABETALOL HYDROCHLORIDECADILA PHARMS LTD

Approval
May 13NEOSTIGMINE METHYLSULFATE ANDA #212512ORIG-1NEOSTIGMINE METHYLSULFATEBE PHARMS

Approval
May 14GEMZAR NDA #020509SUPPL-82GEMCITABINE HYDROCHLORIDELILLYLabelingApproval
May 14EDURANT NDA #202022SUPPL-13RILPIVIRINE HYDROCHLORIDEJANSSEN PRODSLabelingApproval
May 14VASOSTRICT NDA #204485SUPPL-9VASOPRESSINPAR STERILE PRODUCTSLabelingApproval
May 14FULVESTRANT ANDA #205935ORIG-1FULVESTRANTSANDOZ INC

Approval
May 14ALBENDAZOLE ANDA #211117ORIG-1ALBENDAZOLEEDENBRIDGE PHARMS

Approval
May 14GLYCOPYRROLATE ANDA #211334ORIG-1GLYCOPYRROLATESANDOZ INC

Approval
May 14BAVENCIO BLA #761049SUPPL-6AVELUMABEMD SERONO INC

Approval
May 15TRIGLIDE NDA #021350SUPPL-22FENOFIBRATESKYEPHARMA AGLabelingApproval
May 15LIPOFEN NDA #021612SUPPL-20FENOFIBRATECIPHER PHARMS INCLabelingApproval
May 15ANTARA (MICRONIZED) NDA #021695SUPPL-20FENOFIBRATELUPIN ATLANTISLabelingApproval
May 15FENOGLIDE NDA #022118SUPPL-10FENOFIBRATESALIXLabelingApproval
May 15FIBRICOR NDA #022418SUPPL-15FENOFIBRIC ACIDATHENALabelingApproval
May 15ALLOPURINOL ANDA #071450SUPPL-40ALLOPURINOLSUN PHARM INDUSTRIESLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #075753SUPPL-10FENOFIBRATERHODES PHARMSLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #075868SUPPL-20FENOFIBRATEIMPAX LABSLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #202676SUPPL-5FENOFIBRATEMYLAN PHARMS INCLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #205566SUPPL-3FENOFIBRATEGLENMARK PHARMS LTDLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #207378SUPPL-4FENOFIBRATEINVAGEN PHARMSLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #207805SUPPL-8FENOFIBRATEAUSTARPHARMALabelingApproval
May 15ZOLEDRONIC ACID ANDA #208513ORIG-1ZOLEDRONIC ACIDSHILPA MEDICARE LTD

Approval
May 15VENCLEXTA NDA #208573SUPPL-13VENETOCLAXABBVIE INCEfficacyApproval
May 15TRELEGY ELLIPTA NDA #209482SUPPL-5FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEGLAXOSMITHKLINELabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #209504SUPPL-4FENOFIBRATEAMERIGEN PHARMS LTDLabelingApproval
May 15IBUPROFEN ANDA #210149SUPPL-1IBUPROFENGUARDIAN DRUGManufacturing (CMC)Approval
May 15FENOFIBRATE (MICRONIZED) ANDA #210705SUPPL-1FENOFIBRATEAJANTA PHARMA LTDLabelingApproval
May 15FENOFIBRATE (MICRONIZED) ANDA #210782SUPPL-1FENOFIBRATETORRENTLabelingApproval
May 16FRAGMIN NDA #020287SUPPL-72DALTEPARIN SODIUMPFIZER INCEfficacyApproval
May 16AGGRASTAT NDA #020912SUPPL-27TIROFIBAN HYDROCHLORIDEMEDICURELabelingApproval
May 16AGGRASTAT NDA #020913SUPPL-26TIROFIBAN HYDROCHLORIDEMEDICURELabelingApproval
May 16TRACLEER NDA #021290SUPPL-39BOSENTANACTELION PHARMS LTDLabelingApproval
May 16LIVALO NDA #022363SUPPL-15PITAVASTATIN CALCIUMKOWA COEfficacyApproval
May 16GATTEX KIT NDA #203441SUPPL-13TEDUGLUTIDE RECOMBINANTNPS PHARMS INCEfficacyApproval
May 16TESTOSTERONE ANDA #204570SUPPL-1TESTOSTERONEACTAVIS LABS UT INCLabelingApproval
May 16CABAZITAXEL ANDA #207381ORIG-1CABAZITAXELMYLAN LABS LTD

Tentative Approval
May 16RIVAROXABAN ANDA #208549ORIG-1RIVAROXABANPRINSTON INC

Tentative Approval
May 16TRACLEER NDA #209279SUPPL-5BOSENTANACTELION PHARMSLabelingApproval
May 16JORNAY PM NDA #209311SUPPL-3METHYLPHENIDATE HYDROCHLORIDEIRONSHORE PHARMSLabelingApproval
May 16DOCETAXEL ANDA #210327ORIG-1DOCETAXELSHILPA MEDICARE LTD

Approval
May 16DOLUTEGRAVIR ANDA #210963ORIG-1DOLUTEGRAVIRLAURUS LABS LTD

Tentative Approval
May 16DICLOFENAC SODIUM ANDA #211253ORIG-1DICLOFENAC SODIUMGAGE DEVELOPMENT

Approval
May 16CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ANDA #212266ORIG-1CETIRIZINE HYDROCHLORIDEQUAGEN

Approval
May 16HERZUMA BLA #761091SUPPL-1TRASTUZUMAB-PKRBCELLTRION INC

Approval
May 16HERZUMA BLA #761091SUPPL-2TRASTUZUMAB-PKRBCELLTRION INC

Approval
May 17PLAVIX NDA #020839SUPPL-72CLOPIDOGREL BISULFATESANOFI AVENTIS USLabelingApproval
May 17ORFADIN NDA #021232SUPPL-23NITISINONESWEDISH ORPHANLabelingApproval
May 17SUMATRIPTAN SUCCINATE ANDA #078295SUPPL-8SUMATRIPTAN SUCCINATESUN PHARM INDSLabelingApproval
May 17SUMATRIPTAN SUCCINATE ANDA #078327SUPPL-11SUMATRIPTAN SUCCINATEAUROBINDO PHARMALabelingApproval
May 17IMIPENEM AND CILASTATIN ANDA #090825SUPPL-11CILASTATIN SODIUM; IMIPENEMHOSPIRA INCLabelingApproval
May 17IMIPENEM AND CILASTATIN ANDA #090825SUPPL-12CILASTATIN SODIUM; IMIPENEMHOSPIRA INCLabelingApproval
May 17AZELASTINE HYDROCHLORIDE ANDA #091444SUPPL-3AZELASTINE HYDROCHLORIDEWEST-WARD PHARMS INTLabelingApproval
May 17PROLEUKIN BLA #103293SUPPL-5146ALDESLEUKINCHIRON

Approval
May 17TELMISARTAN ANDA #202397SUPPL-6TELMISARTANMYLANLabelingApproval
May 17TELMISARTAN ANDA #203867SUPPL-7TELMISARTANSANDOZ INCLabelingApproval
May 17MELPHALAN HYDROCHLORIDE ANDA #204817ORIG-1MELPHALAN HYDROCHLORIDEALVOGEN INC

Approval
May 17ORFADIN NDA #206356SUPPL-6NITISINONESWEDISH ORPHANLabelingApproval
May 17MICAFUNGIN SODIUM ANDA #207344ORIG-1MICAFUNGIN SODIUMFRESENIUS KABI USA

Approval
May 17AZELASTINE HYDROCHLORIDE ANDA #207610ORIG-1AZELASTINE HYDROCHLORIDEHI TECH

Approval
May 17LURASIDONE HYDROCHLORIDE ANDA #208060ORIG-1LURASIDONE HYDROCHLORIDETEVA PHARMS USA

Approval
May 17TELMISARTAN ANDA #208605SUPPL-1TELMISARTANCADILA PHARMS LTDLabelingApproval
May 17CINACALCET HYDROCHLORIDE ANDA #210570ORIG-1CINACALCET HYDROCHLORIDEALKEM LABS LTD

Approval
May 17DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #210651ORIG-1AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATERHODES PHARMS

Approval
May 17NAYZILAM NDA #211321ORIG-1MIDAZOLAMPROXIMAGEN LLCType 3 - New Dosage FormApproval
May 17ZULRESSO NDA #211371SUPPL-1BREXANOLONESAGE THERAPEUTICSREMSApproval
May 17DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #211715ORIG-1AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATESUN PHARM INDUSTRIES

Approval
May 19MOMETASONE FUROATE ANDA #076624SUPPL-8MOMETASONE FUROATETAROLabelingApproval
May 19BENAZEPRIL HYDROCHLORIDE ANDA #076820SUPPL-18BENAZEPRIL HYDROCHLORIDEAMNEAL PHARMSLabelingApproval
May 19LETROZOLE ANDA #090289SUPPL-4LETROZOLETEVA PHARMSLabelingApproval
May 19LETROZOLE ANDA #090289SUPPL-5LETROZOLETEVA PHARMSLabelingApproval
May 19LETROZOLE ANDA #091303SUPPL-2LETROZOLEAPOTEX INCLabelingApproval
May 19LETROZOLE ANDA #091303SUPPL-3LETROZOLEAPOTEX INCLabelingApproval
May 19LETROZOLE ANDA #202716SUPPL-2LETROZOLEJIANGSU HENGRUI MEDLabelingApproval
May 19LETROZOLE ANDA #202716SUPPL-3LETROZOLEJIANGSU HENGRUI MEDLabelingApproval
May 20APOKYN NDA #021264SUPPL-16APOMORPHINE HYDROCHLORIDEUS WORLDMEDSLabelingApproval
May 20FASLODEX NDA #021344SUPPL-39FULVESTRANTASTRAZENECALabelingApproval
May 20PEMETREXED ANDA #090352ORIG-1PEMETREXED SODIUMTEVA PHARMS USA

Tentative Approval
May 20DONEPEZIL HYDROCHLORIDE ANDA #090686SUPPL-12DONEPEZIL HYDROCHLORIDETORRENT PHARMSLabelingApproval
May 20SOLIFENACIN SUCCINATE ANDA #202551ORIG-1SOLIFENACIN SUCCINATEWATSON LABS INC

Approval
May 20DONEPEZIL HYDROCHLORIDE ANDA #203656SUPPL-1DONEPEZIL HYDROCHLORIDEUNICHEM LABS LTDLabelingApproval
May 20DACTINOMYCIN ANDA #203999ORIG-1DACTINOMYCINX-GEN PHARMS INC

Approval
May 20DONEPEZIL HYDROCHLORIDE ANDA #204609SUPPL-2DONEPEZIL HYDROCHLORIDECADILA PHARMS LTDLabelingApproval
May 20SOLIFENACIN SUCCINATE ANDA #205483ORIG-1SOLIFENACIN SUCCINATEAJANTA PHARMA LTD

Approval
May 20SOLIFENACIN SUCCINATE ANDA #205575ORIG-1SOLIFENACIN SUCCINATEALEMBIC PHARMS LTD

Approval
May 20ALBENDAZOLE ANDA #208094ORIG-1ALBENDAZOLEACTAVIS ELIZABETH

Approval
May 20SOLIFENACIN SUCCINATE ANDA #209239ORIG-1SOLIFENACIN SUCCINATEGLENMARK PHARMS INC

Approval
May 20SOLIFENACIN SUCCINATE ANDA #209333ORIG-1SOLIFENACIN SUCCINATEQILU PHARM CO LTD

Approval
May 20SOLIFENACIN SUCCINATE ANDA #209719ORIG-1SOLIFENACIN SUCCINATEAMNEAL PHARMS CO

Approval
May 20SOLIFENACIN SUCCINATE ANDA #209818ORIG-1SOLIFENACIN SUCCINATEBRECKENRIDGE PHARM

Approval
May 20SOLIFENACIN SUCCINATE ANDA #209839ORIG-1SOLIFENACIN SUCCINATECIPLA

Approval
May 20METHYLPREDNISOLONE ACETATE ANDA #210043ORIG-1METHYLPREDNISOLONE ACETATEAMNEAL PHARMS CO

Approval
May 20SOLIFENACIN SUCCINATE ANDA #210224ORIG-1SOLIFENACIN SUCCINATEALKEM LABS LTD

Approval
May 20SOLIFENACIN SUCCINATE ANDA #210281ORIG-1SOLIFENACIN SUCCINATEJIANGXI BOYA SEEHOT

Approval
May 20FULVESTRANT NDA #210326ORIG-1FULVESTRANTFRESENIUS KABI USAType 5 - New Formulation or New ManufacturerApproval
May 20DIMETHYL FUMARATE ANDA #210492ORIG-1DIMETHYL FUMARATESUN PHARM INDS LTD

Tentative Approval
May 20SOLIFENACIN SUCCINATE ANDA #210582ORIG-1SOLIFENACIN SUCCINATECELLTRION

Approval
May 20SOLIFENACIN SUCCINATE ANDA #210688ORIG-1SOLIFENACIN SUCCINATEMSN LABS PVT LTD

Approval
May 20SOLIFENACIN SUCCINATE ANDA #211657ORIG-1SOLIFENACIN SUCCINATESCIEGEN PHARMS INC

Approval
May 21WELCHOL NDA #021176SUPPL-45COLESEVELAM HYDROCHLORIDEDAIICHI SANKYOLabelingApproval
May 21WELCHOL NDA #022362SUPPL-25COLESEVELAM HYDROCHLORIDEDAIICHI SANKYOLabelingApproval
May 21CLEOCIN NDA #050680SUPPL-17CLINDAMYCIN PHOSPHATEPHARMACIA AND UPJOHNLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #077518SUPPL-2DONEPEZIL HYDROCHLORIDECIPLA LTDLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #090056SUPPL-10DONEPEZIL HYDROCHLORIDEAUROBINDOLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #090290SUPPL-9DONEPEZIL HYDROCHLORIDESANDOZLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #201724SUPPL-5DONEPEZIL HYDROCHLORIDEALEMBIC PHARMS LTDLabelingApproval
May 21LOSARTAN POTASSIUM ANDA #202230SUPPL-10LOSARTAN POTASSIUMMACLEODS PHARMS LTDLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #202723SUPPL-4DONEPEZIL HYDROCHLORIDEDR REDDYSLabelingApproval
May 21DONEPEZIL HYDROCHLORIDE ANDA #202723SUPPL-5DONEPEZIL HYDROCHLORIDEDR REDDYSLabelingApproval
May 21PARICALCITOL ANDA #206699SUPPL-1PARICALCITOLAMNEAL PHARMS COLabelingApproval
May 21DALFAMPRIDINE ANDA #208292ORIG-1DALFAMPRIDINESUN PHARM

Approval
May 21YUPELRI NDA #210598SUPPL-1REVEFENACINMYLAN IRELAND LTDLabelingApproval
May 22SOTRADECOL ANDA #040541SUPPL-15SODIUM TETRADECYL SULFATEMYLAN INSTITUTIONALLabelingApproval
May 22OFLOXACIN ANDA #076093SUPPL-11OFLOXACINLARKEN LABSLabelingApproval
May 22SUMATRIPTAN SUCCINATE ANDA #090358SUPPL-15SUMATRIPTAN SUCCINATESUN PHARMLabelingApproval
May 22DULOXETINE HYDROCHLORIDE ANDA #090739SUPPL-13DULOXETINE HYDROCHLORIDEZYDUS HLTHCARELabelingApproval
May 22LEVOFLOXACIN ANDA #091678SUPPL-4LEVOFLOXACINHI TECH PHARMALabelingApproval
May 22DECITABINE NDA #205582SUPPL-9DECITABINESUN PHARMA GLOBALLabelingApproval
May 22ESOMEPRAZOLE MAGNESIUM ANDA #206296ORIG-1ESOMEPRAZOLE MAGNESIUMZYDUS PHARMS

Approval
May 22GEMCITABINE HYDROCHLORIDE ANDA #206776SUPPL-3GEMCITABINE HYDROCHLORIDEAPOTEX INCLabelingApproval
May 22PHYTONADIONE ANDA #207719ORIG-1PHYTONADIONEDR REDDYS LABS LTD

Approval
May 22SIKLOS NDA #208843SUPPL-2HYDROXYUREAADDMEDICA SASLabelingApproval
May 22EPIDIOLEX NDA #210365SUPPL-4CANNABIDIOLGW RES LTDManufacturing (CMC)Approval
May 22ERLOTINIB ANDA #211083ORIG-1ERLOTINIBACCORD HLTHCARE INC

Tentative Approval
May 22TRIENTINE HYDROCHLORIDE

ANDA #211134

ORIG-1TRIENTINE HYDROCHLORIDEMSN LABS PVT LTD

Approval
May 22CYPROHEPTADINE HYDROCHLORIDE ANDA #212423ORIG-1CYPROHEPTADINE HYDROCHLORIDEQUAGEN

Approval
May 23LYRICA NDA #021446SUPPL-36PREGABALINPF PRISM CVEfficacyApproval
May 23LYRICA NDA #022488SUPPL-14PREGABALINPF PRISM CVEfficacyApproval
May 23LEVOFLOXACIN ANDA #091678SUPPL-6LEVOFLOXACINHI TECH PHARMALabelingApproval
May 23ENSKYCE ANDA #201887SUPPL-8DESOGESTREL; ETHINYL ESTRADIOLLUPIN LTDLabelingApproval
May 23ENSKYCE ANDA #201887SUPPL-10DESOGESTREL; ETHINYL ESTRADIOLLUPIN LTDLabelingApproval
May 23ENSKYCE ANDA #201887SUPPL-13DESOGESTREL; ETHINYL ESTRADIOLLUPIN LTDManufacturing (CMC)Approval
May 23FLUOXETINE HYDROCHLORIDE ANDA #206993ORIG-1FLUOXETINE HYDROCHLORIDECADILA PHARMS LTD

Approval
May 23PEMETREXED SODIUM ANDA #208262ORIG-1PEMETREXED SODIUMWOCKHARDT BIO AG

Tentative Approval
May 23POTASSIUM CHLORIDE ANDA #210902ORIG-1POTASSIUM CHLORIDEAMNEAL PHARMS LLC

Approval
May 23PEMETREXED DISODIUM NDA #211090ORIG-1PEMETREXED DISODIUMBIOCON PHARMA LTD

Tentative Approval
May 23SLYND NDA #211367ORIG-1DROSPIRENONEEXELTIS USA INCType 2 - New Active Ingredient and Type 3 - New Dosage FormApproval
May 23METHYLPHENIDATE HYDROCHLORIDE ANDA #211796ORIG-1METHYLPHENIDATE HYDROCHLORIDEGRANULES PHARMS

Approval
May 23CLOBAZAM ANDA #212398ORIG-1CLOBAZAMACCORD HLTHCARE

Approval
May 23TRUXIMA BLA #761088SUPPL-1RITUXIMAB-ABBSCELLTRION INC

Approval
May 23TRUXIMA BLA #761088SUPPL-2RITUXIMAB-ABBSCELLTRION INC

Approval
May 24DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020201SUPPL-40DOBUTAMINE HYDROCHLORIDEHOSPIRALabelingApproval
May 24EXJADE NDA #021882SUPPL-31DEFERASIROXNOVARTISEfficacyApproval
May 24OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078394SUPPL-14IBUPROFEN; OXYCODONE

HYDROCHLORIDE

WATSON LABSLabelingApproval
May 24CALCIPOTRIENE ANDA #090633SUPPL-5CALCIPOTRIENEGLENMARK PHARMS INCLabelingApproval
May 24CALCIPOTRIENE ANDA #090633SUPPL-6CALCIPOTRIENEGLENMARK PHARMS INCLabelingApproval
May 24PROLIA BLA #125320SUPPL-195DENOSUMABAMGEN

Approval
May 24XGEVA BLA #125320SUPPL-195DENOSUMABAMGEN

Approval
May 24METOCLOPRAMIDE HYDROCHLORIDE ANDA #202191SUPPL-5METOCLOPRAMIDE HYDROCHLORIDENOVEL LABS INCLabelingApproval
May 24JAKAFI NDA #202192SUPPL-17RUXOLITINIB PHOSPHATEINCYTE CORPEfficacyApproval
May 24VRAYLAR NDA #204370SUPPL-6CARIPRAZINE HYDROCHLORIDEALLERGAN SALES LLCEfficacyApproval
May 24JADENU NDA #206910SUPPL-14DEFERASIROXNOVARTIS PHARMS CORPEfficacyApproval
May 24JADENU SPRINKLE NDA #207968SUPPL-8DEFERASIROXNOVARTIS PHARMS CORPEfficacyApproval
May 24ALIQOPA NDA #209936SUPPL-2COPANLISIB DIHYDROCHLORIDEBAYER HEALTHCARELabelingApproval
May 24BRAFTOVI NDA #210496SUPPL-3ENCORAFENIBARRAY BIOPHARMA INCEfficacyApproval
May 24DAPAGLIFLOZIN ANDA #211156ORIG-1DAPAGLIFLOZININVENTIA HLTHCARE

Tentative Approval
May 24PIQRAY NDA #212526ORIG-1ALPELISIBNOVARTIS PHARMS CORPType 1 - New Molecular EntityApproval
May 28REVLIMID NDA #021880SUPPL-57LENALIDOMIDECELGENEEfficacyApproval
May 28PREZISTA NDA #021976SUPPL-56DARUNAVIR ETHANOLATEJANSSEN PRODSLabelingApproval
May 28LINEZOLID ANDA #200904SUPPL-4LINEZOLIDSANDOZ INCLabelingApproval
May 28LINEZOLID ANDA #200904SUPPL-8LINEZOLIDSANDOZ INCLabelingApproval
May 28PREZISTA NDA #202895SUPPL-27DARUNAVIR ETHANOLATEJANSSEN PRODSLabelingApproval
May 28CLOPIDOGREL BISULFATE ANDA #204359SUPPL-3CLOPIDOGREL BISULFATECSPC OUYILabelingApproval
May 28CLOPIDOGREL BISULFATE ANDA #204359SUPPL-4CLOPIDOGREL BISULFATECSPC OUYILabelingApproval
May 28CLOPIDOGREL BISULFATE ANDA #204359SUPPL-5CLOPIDOGREL BISULFATECSPC OUYILabelingApproval
May 28CLOPIDOGREL BISULFATE ANDA #204359SUPPL-7CLOPIDOGREL BISULFATECSPC OUYIManufacturing (CMC)Approval
May 28CLOPIDOGREL BISULFATE ANDA #204359SUPPL-8CLOPIDOGREL BISULFATECSPC OUYILabelingApproval
May 28LOPERAMIDE HYDROCHLORIDE ANDA #206548SUPPL-1LOPERAMIDE HYDROCHLORIDEAUROBINDO PHARMA LTDManufacturing (CMC)Approval
May 28LINEZOLID ANDA #207354SUPPL-3LINEZOLIDNANG KUANG PHARM COLabelingApproval
May 28LINEZOLID ANDA #207354SUPPL-4LINEZOLIDNANG KUANG PHARM COLabelingApproval
May 28RANOLAZINE ANDA #208862ORIG-1RANOLAZINEACTAVIS ELIZABETH

Approval
May 28MELPHALAN HYDROCHLORIDE ANDA #209826ORIG-1MELPHALAN HYDROCHLORIDEGLAND PHARMA LTD

Approval
May 28RANOLAZINE ANDA #210054ORIG-1RANOLAZINEAJANTA PHARMA LTD

Approval
May 28HEPARIN SODIUM ANDA #211007ORIG-1HEPARIN SODIUMNANJING KING-FRIEND

Approval
May 28RANOLAZINE ANDA #211291ORIG-1RANOLAZINECIPLA

Approval
May 28RANOLAZINE ANDA #211707ORIG-1RANOLAZINESUN PHARM

Approval
May 29SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #016677SUPPL-169SODIUM CHLORIDEBAXTER HLTHCARELabelingApproval
May 29SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018016SUPPL-67SODIUM CHLORIDEBAXTER HLTHCARELabelingApproval
May 29SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #020178SUPPL-21SODIUM CHLORIDEBAXTER HLTHCARELabelingApproval
May 29BROVANA NDA #021912SUPPL-32ARFORMOTEROL TARTRATESUNOVIONLabelingApproval
May 29PERFOROMIST NDA #022007SUPPL-15FORMOTEROL FUMARATEMYLAN SPECLTLabelingApproval
May 29ARCAPTA NEOHALER NDA #022383SUPPL-7INDACATEROL MALEATESUNOVION PHARMS INCLabelingApproval
May 29ROCURONIUM BROMIDE ANDA #091115SUPPL-11ROCURONIUM BROMIDETAMARANGLabelingApproval
May 29STRIVERDI RESPIMAT NDA #203108SUPPL-8OLODATEROL HYDROCHLORIDEBOEHRINGER

INGELHEIM

LabelingApproval
May 29ANORO ELLIPTA NDA #203975SUPPL-9UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEGLAXOSMITHKLINELabelingApproval
May 29MOVANTIK NDA #204760SUPPL-8NALOXEGOL OXALATEASTRAZENECA PHARMSLabelingApproval
May 29DAPIPRAZOLE HYDROCHLORIDE ANDA #204902ORIG-1DAPIPRAZOLE HYDROCHLORIDEBARADAINA LLC

Approval
May 29PREZCOBIX NDA #205395SUPPL-14COBICISTAT; DARUNAVIR ETHANOLATEJANSSEN PRODSLabelingApproval
May 29STIOLTO RESPIMAT NDA #206756SUPPL-11OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDEBOEHRINGER INGELHEIMLabelingApproval
May 29UTIBRON NDA #207930SUPPL-4GLYCOPYRROLATE ; INDACATEROL

MALEATE

SUNOVION PHARMS INCLabelingApproval
May 29BEVESPI AEROSPHERE NDA #208294SUPPL-5FORMOTEROL FUMARATE; GLYCOPYRROLATEASTRAZENECA PHARMSLabelingApproval
May 29PLENVU NDA #209381SUPPL-2ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATESALIXLabelingApproval
May 29XOSPATA NDA #211349SUPPL-1GILTERITINIB FUMARATEASTELLASEfficacyApproval
May 29FULPHILA BLA #761075SUPPL-4PEGFILGRASTIM-JMDBMYLAN GMBH

Approval
May 30ANDROGEL NDA #021015SUPPL-46TESTOSTERONEABBVIEREMSApproval
May 30TESTIM NDA #021454SUPPL-29TESTOSTERONEAUXILIUM PHARMS LLCREMSApproval
May 30FORTESTA NDA #021463SUPPL-21TESTOSTERONEENDO PHARMSREMSApproval
May 30ALLEGRA NDA #021963SUPPL-7FEXOFENADINE HYDROCHLORIDESANOFI AVENTIS USLabelingApproval
May 30ANDROGEL NDA #022309SUPPL-21TESTOSTERONEABBVIEREMSApproval
May 30MOZOBIL NDA #022311SUPPL-20PLERIXAFORGENZYMELabelingApproval
May 30MYOZYME BLA #125141SUPPL-222ALGLUCOSIDASE ALFAGENZYME

Approval
May 30LUMIZYME BLA #125291SUPPL-148ALGLUCOSIDASE ALFAGENZYME

Approval
May 30FYCOMPA NDA #202834SUPPL-16PERAMPANELEISAI INCLabelingApproval
May 30VOGELXO NDA #204399SUPPL-11TESTOSTERONEUPSHER SMITH LABSREMSApproval
May 30VIGABATRIN ANDA #208218SUPPL-4VIGABATRINPAR PHARM INCREMSApproval
May 30FYCOMPA NDA #208277SUPPL-4PERAMPANELEISAI INCLabelingApproval
May 30VIGABATRIN ANDA #209822SUPPL-2VIGABATRINTEVA PHARMS USAREMSApproval
May 30VIGABATRIN ANDA #209824SUPPL-2VIGABATRINTEVA PHARMS USAREMSApproval
May 30VIGABATRIN ANDA #210155SUPPL-2VIGABATRINAMNEAL PHARMSREMSApproval
May 30VIGADRONE ANDA #210196SUPPL-1VIGABATRINSHANGHAIREMSApproval
May 30SYMTUZA NDA #210455SUPPL-4COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATEJANSSEN PRODSLabelingApproval
May 30VIGABATRIN ANDA #211481SUPPL-1VIGABATRINDR REDDYS LABS LTDREMSApproval
May 31SABRIL NDA #020427SUPPL-19VIGABATRINLUNDBECK PHARMS LLCREMSApproval
May 31SABRIL NDA #022006SUPPL-21VIGABATRINLUNDBECK PHARMS LLCREMSApproval
May 31GLIMEPIRIDE ANDA #076802SUPPL-20GLIMEPIRIDETEVALabelingApproval
May 31GLIMEPIRIDE ANDA #077091SUPPL-15GLIMEPIRIDEDR REDDYS LABS LTDLabelingApproval
May 31GLIMEPIRIDE ANDA #077091SUPPL-17GLIMEPIRIDEDR REDDYS LABS LTDLabelingApproval
May 31GLIMEPIRIDE ANDA #077274SUPPL-9GLIMEPIRIDEEPIC PHARMA LLCLabelingApproval
May 31GLIMEPIRIDE ANDA #077624SUPPL-7GLIMEPIRIDEMYLANLabelingApproval
May 31GLIMEPIRIDE ANDA #077911SUPPL-4GLIMEPIRIDECARLSBADLabelingApproval
May 31GLIMEPIRIDE ANDA #077911SUPPL-5GLIMEPIRIDECARLSBADLabelingApproval
May 31GLIMEPIRIDE ANDA #078181SUPPL-14GLIMEPIRIDEACCORD HLTHCARELabelingApproval
May 31MEMANTINE HYDROCHLORIDE ANDA #200891SUPPL-6MEMANTINE HYDROCHLORIDEALEMBIC PHARMS LTDLabelingApproval
May 31GLIMEPIRIDE ANDA #202759SUPPL-8GLIMEPIRIDEAUROBINDO PHARMA LTDLabelingApproval
May 31PROCYSBI NDA #203389SUPPL-22CYSTEAMINE BITARTRATEHORIZON PHARMA USALabelingApproval
May 31TESTOSTERONE ANDA #204255SUPPL-5TESTOSTERONEPERRIGO ISRAELREMSApproval
May 31ENTECAVIR ANDA #205740SUPPL-2ENTECAVIRHETERO LABS LTD VLabelingApproval
May 31ENTECAVIR ANDA #205740SUPPL-3ENTECAVIRHETERO LABS LTD VLabelingApproval
May 31DEXTROAMP SACCHARATE, AMP ASPARTATE, DETROAMP SULFATE AND AMP SULFATE ANDA #206159ORIG-1AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATEPAR PHARM INC

Approval
May 31BUSULFAN ANDA #209580SUPPL-1BUSULFANAMNEAL PHARMS COLabelingApproval
May 31BUSULFAN ANDA #209580SUPPL-2BUSULFANAMNEAL PHARMS COLabelingApproval
May 31ATOVAQUONE ANDA #210510ORIG-1ATOVAQUONEABHAI LLC

Approval
May 31CARFILZOMIB ANDA #211185ORIG-1CARFILZOMIBAPOTEX INC

Tentative Approval
May 31FELBAMATE ANDA #211333ORIG-1FELBAMATEVISTAPHARM

Approval
May 31SILDENAFIL CITRATE ANDA #212260ORIG-1SILDENAFIL CITRATENOVITIUM PHARMA

Approval
Source: U.S. Food and Drug Administration

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