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DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
NDA · New Drug Application · Sponsor: AUROBINDO PHARMA USA · Approved 2023-05-26
Drug application
- FDA Application #
NDA215448- Application type
- New Drug Application
- Brand name
- DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
- Generic name
- Dolutegravir, Emtricitabine And Tenofovir Alafenamide
- Active ingredients
- DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- AUROBINDO PHARMA USA
- First approval
- 2023-05-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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