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ACTIVE SUBSTANCE / INN

EMTRICITABINE

Brand name(s): EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE, ODEFSEY, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, SYMTUZA, GENVOYA, Emtriva, EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE, ATRIPLA
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA208351
HIV Infections
ACTIVE SUBSTANCE
Emtricitabine
REGULATORS
FDA · EMA
SPONSORS / MAH
JANSSEN PRODS, GILEAD SCIENCES INC, Gilead Sciences Ireland UC
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EMTRICITABINEANDA091168CIPLAPrescription
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEANDA091593CIPLA LIMITEDNone (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATEANDA214053APOTEXDiscontinued
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEANDA203053HETERO LABS LTD VPrescription
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEANDA204131CHARTWELL RXPrescription
GENVOYANDA207561GILEAD SCIENCES INCPrescription
SYMTUZANDA210455JANSSEN PRODSPrescription
ATRIPLANDA021937GILEAD SCIENCESDiscontinued
ODEFSEYNDA208351GILEAD SCIENCES INCPrescription
EMTRICITABINEANDA090488MATRIX LABS LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
EmtrivaGilead Sciences Ireland UCAuthorised24/10/2003HIV Infections

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