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ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2026-02-09

Drug application

FDA Application #
ANDA218575
Application type
Abbreviated New Drug Application (Generic)
Brand name
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Generic name
Elvitegravir, Cobicistat, Emtricitabine And Tenofovir Alafenamide
Active ingredients
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
APOTEX INC
First approval
2026-02-09

Source

Authoritative
Drugs@FDA application overview
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