# ODEFSEY
> **NDA208351** · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2016-03-01
## Drug
- **FDA Application Number:** NDA208351
- **Application type:** New Drug Application
- **Brand name:** ODEFSEY
- **Generic name:** EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE
- **Active ingredients:** EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GILEAD SCIENCES INC
- **Manufacturer:** Gilead Sciences, Inc.
- **First approval:** 2016-03-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208351)
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