← FDA DRUG APPROVALS
FDA ANDA · ANDA214095
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
Sponsor: APOTEX
APPLICATION
ANDA214095
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-30
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDEDiscontinued
EMTRICITABINE 200MG, RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE, TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE · TABLET · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.