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ACTIVE SUBSTANCE / INN

DOLUTEGRAVIR SODIUM

Brand name(s): TRIUMEQ, TRIUMEQ PD, DOLUTEGRAVIR SODIUM, TIVICAY PD, DOVATO, TIVICAY, JULUCA
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA210192
ANDA209602
ACTIVE SUBSTANCE
Dolutegravir Sodium
REGULATORS
FDA
SPONSORS / MAH
VIIV HLTHCARE, MYLAN LABS LTD
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DOLUTEGRAVIR SODIUMANDA209602MYLAN LABS LTDNone (Tentative Approval)
DOVATONDA211994VIIV HLTHCAREPrescription
TRIUMEQ PDNDA215413VIIV HLTHCAREPrescription
JULUCANDA210192VIIV HLTHCAREPrescription
TIVICAY PDNDA213983VIIV HLTHCAREPrescription
TIVICAYNDA204790VIIV HLTHCAREDiscontinued
TIVICAYNDA204790VIIV HLTHCAREPrescription
TRIUMEQNDA205551VIIV HLTHCAREPrescription

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