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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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