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BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA LTD · Approved 2025-10-14
Drug application
- FDA Application #
ANDA218766- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
- Generic name
- Bictegravir, Emtricitabine And Tenofovir Alafenamide
- Active ingredients
- BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
- Dosage form
- TABLET
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- CIPLA LTD
- First approval
- 2025-10-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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