ANDA 78864, held by Pharmobedient. Nevirapine.
As of Nov 15, 2026, ANDA 78864 (Nevirapine), held by Pharmobedient, was first approved by FDA on May 22, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG ยท tablet;oral | Nevirapine | Discontinued |
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