# DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
> **NDA209670** · New Drug Application · Sponsor: MYLAN PHARMS INC · Approved 2017-08-02
## Drug
- **FDA Application Number:** NDA209670
- **Application type:** New Drug Application
- **Brand name:** DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
- **Generic name:** Dolutegravir
- **Active ingredients:** DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** MYLAN PHARMS INC
- **First approval:** 2017-08-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209670)
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