Treats human immunodeficiency virus (HIV-1) infection. ANDA 202523, held by Mylan Pharms Inc. Nevirapine.
As of Nov 15, 2026, ANDA 202523 (Nevirapine), held by Mylan Pharms Inc, was first approved by FDA on May 22, 2012, with 4 approved supplements and 0 published complete response letters.
Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Rx |
| Mar 21, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 21, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 21, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 21, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 22, 2012 | Original application | Approved | None posted |
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
