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ACTIVE SUBSTANCE / INN

TENOFOVIR ALAFENAMIDE FUMARATE

Brand name(s): TENOFOVIR ALAFENAMIDE FUMARATE, VEMLIDY, DESCOVY, SYMTUZA, GENVOYA, EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE, BIKTARVY, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, ODEFSEY
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA214030
NDA208351
ACTIVE SUBSTANCE
Tenofovir Alafenamide Fumarate
REGULATORS
FDA
SPONSORS / MAH
GILEAD SCIENCES INC, JANSSEN PRODS, LAURUS LABS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATEANDA214053APOTEXDiscontinued
GENVOYANDA207561GILEAD SCIENCES INCPrescription
SYMTUZANDA210455JANSSEN PRODSPrescription
ODEFSEYNDA208351GILEAD SCIENCES INCPrescription
VEMLIDYNDA208464GILEAD SCIENCES INCPrescription
BIKTARVYNDA210251GILEAD SCIENCES INCPrescription
TENOFOVIR ALAFENAMIDE FUMARATEANDA214030LAURUS LABS LTDNone (Tentative Approval)
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDEANDA214095APOTEXPrescription
TENOFOVIR ALAFENAMIDE FUMARATEANDA213867APOTEXDiscontinued
DESCOVYNDA208215GILEAD SCIENCES INCPrescription

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