Treats human immunodeficiency virus (HIV-1) infection. ANDA 203080, held by Micro Labs Ltd. Nevirapine.
As of Nov 15, 2026, ANDA 203080 (Nevirapine), held by Micro Labs Ltd, was first approved by FDA on May 22, 2012, with 3 approved supplements and 0 published complete response letters.
Nevirapine tablet 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 tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4 + cell counts greater than 250 cells/mm 3 or adult males with CD4 + cell counts greater than 400 cells/mm 3.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Rx |
| May 23, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 21, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 21, 2020 | Supplement 3Labeling · 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
