← FDA Drug Approvals (Drugs@FDA)
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
NDA · New Drug Application · Sponsor: LUPIN LTD · Approved 2023-01-19
Drug application
- FDA Application #
NDA214544- Application type
- New Drug Application
- Brand name
- DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
- Generic name
- Dolutegravir
- Active ingredients
- DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- LUPIN LTD
- First approval
- 2023-01-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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