Drug application
ODEFSEY (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR ALAFENAMIDE FUMARATE)
Drugs@FDA NDA 208351 · GILEAD SCIENCES INC
Key facts
| Drug name | ODEFSEY |
|---|---|
| Active ingredients | EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, TENOFOVIR ALAFENAMIDE FUMARATE |
| Application type | NDA |
| Application number | 208351 |
| Company | GILEAD SCIENCES INC |
| Dosage forms | TABLET, ORAL |
| Strength | 200MG;EQ 25MG BASE;EQ 25MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Mar 1, 2016 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: