# DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
> **NDA214544** · New Drug Application · Sponsor: LUPIN LTD · Approved 2023-01-19
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214544)
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