NDA 201152, held by Boehringer Ingelheim. Nevirapine.
As of Nov 13, 2026, NDA 201152 (Viramune Xr), held by Boehringer Ingelheim, was first approved by FDA on Mar 25, 2011, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2012 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2012 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Viramune Xr400MG · tablet, extended release;oral | Nevirapine | DiscontinuedReference drug |
| Viramune Xr100MG · tablet, extended release;oral | Nevirapine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Jun 10, 2022 | Supplement 14Labeling · Standard review | Approved | |
| Sep 24, 2018 | Supplement 13Labeling · Standard review | Approved | |
| Mar 27, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Jan 27, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Nov 8, 2012 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2012 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2011 | Supplement 2Labeling · Standard review | Approved | |
| May 6, 2011 | Supplement 1REMS | Approved | |
| Mar 25, 2011 | Original applicationNew dosage form · Standard review | 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
