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EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2026-01-30

Drug application

FDA Application #
ANDA214095
Application type
Abbreviated New Drug Application (Generic)
Brand name
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
Generic name
Emtricitabine
Active ingredients
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
APOTEX
First approval
2026-01-30

Source

Authoritative
Drugs@FDA application overview
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