ANDA 206271, held by Pharmobedient. Nevirapine.
As of Nov 15, 2026, ANDA 206271 (Nevirapine), held by Pharmobedient, was first approved by FDA on Nov 9, 2015, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine100MG · tablet, extended release;oral | Nevirapine | Discontinued |
| Aug 21, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 9, 2015 | Original application | Approved |
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
