ANDA 214196, held by Amneal. Etravirine.
As of Nov 15, 2026, ANDA 214196 (Etravirine), held by Amneal, was first approved by FDA on Jun 14, 2021, with 0 approved supplements and 0 published complete response letters.
Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older. Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2021 | Original application | Approved |
| Etravirine25MG · tablet;oral | Etravirine | Discontinued |
| Etravirine100MG · tablet;oral | Etravirine | Rx |
| Etravirine200MG · tablet;oral | Etravirine | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
