Active ingredient
Etravirine
16 finished FDA listings contain Etravirine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ETRAVIRINE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 100 mg/1 · 200 mg/1 · 25 mg/1
- Brand names in FDA listings
- Intelence
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 475969
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022187 | JANSSEN R AND D | 2008-01-18 | 5 |
| ANDA 214196 | AMNEAL | 2021-06-14 | 5 |
| ANDA 215402 | PHARMOBEDIENT | 2022-04-13 | 4 |
| ANDA 219152 | BIONPHARMA | 2025-10-02 | 2 |
Official labeling on DailyMed
- ETRAVIRINE TABLET [AVKARE] · version 3 · 2026-01-14
- ETRAVIRINE TABLET [BIONPHARMA INC.] · version 1 · 2026-01-02
- ETRAVIRINE TABLET [AMNEAL PHARMACEUTICALS NY LLC] · version 10 · 2025-10-06
- ETRAVIRINE TABLET [PATRIOT PHARMACEUTICALS] · version 3 · 2025-04-07
- ETRAVIRINE TABLET [CARNEGIE PHARMACEUTICALS LLC] · version 6 · 2024-03-07
- ETRAVIRINE TABLET [LEADING PHARMA, LLC] · version 2 · 2024-01-10
- INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP] · version 24 · 2023-08-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.