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DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
NDA · New Drug Application · Sponsor: CIPLA USA INC. · Approved 2022-03-30
Drug application
- FDA Application #
NDA212527
- Application type
- New Drug Application
- Brand name
- DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
- Generic name
- Dolutegravir Lamivudine Tenofovir Alafenamide
- Active ingredients
- DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
- Dosage form
- TABLET
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- CIPLA USA INC.
- First approval
- 2022-03-30
Source
- Authoritative
- Drugs@FDA application overview
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