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ACTIVE SUBSTANCE / INN

RILPIVIRINE HYDROCHLORIDE

Brand name(s): COMPLERA, EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE, RILPIVIRINE HYDROCHLORIDE, EDURANT, EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE, ODEFSEY, EDURANT PED, JULUCA
FDA LISTED
PRESCRIPTION
NDA210192
NDA202022
ACTIVE SUBSTANCE
Rilpivirine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
JANSSEN PRODS, LAURUS, GILEAD SCIENCES INC
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RILPIVIRINE HYDROCHLORIDEANDA218798SOMERSET THERAPS LLCPrescription
ODEFSEYNDA208351GILEAD SCIENCES INCPrescription
JULUCANDA210192VIIV HLTHCAREPrescription
COMPLERANDA202123GILEAD SCIENCES INCPrescription
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATEANDA220232LAURUSPrescription
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDEANDA214095APOTEXPrescription
EDURANTNDA202022JANSSEN PRODSPrescription
EDURANT PEDNDA219016JANSSEN PRODSPrescription

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