ACTIVE SUBSTANCE / INN

TENOFOVIR ALAFENAMIDE

Brand name(s): EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE, Vemlidy, EMTRICITABINE; TENOFOVIR ALAFENAMIDE, TENOFOVIR ALAFENAMIDE, DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE, DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
NDA215187
NDA214544
ACTIVE SUBSTANCE
Tenofovir Alafenamide
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, Gilead Sciences Ireland UC, AUROBINDO PHARMA
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TENOFOVIR ALAFENAMIDEANDA213845SUNSHINE LAKENone (Tentative Approval)
EMTRICITABINE; TENOFOVIR ALAFENAMIDEANDA216875AUROBINDO PHARMANone (Tentative Approval)
EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDEANDA214058CIPLA LIMITEDNone (Tentative Approval)
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA214544LUPIN LTDNone (Tentative Approval)
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDENDA215187LUPIN PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
VemlidyGilead Sciences Ireland UCAuthorised09/01/2017Hepatitis B

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