# DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
> **NDA215448** · New Drug Application · Sponsor: AUROBINDO PHARMA USA · Approved 2023-05-26
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215448)
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