Treats human immunodeficiency virus (HIV-1) infection. ANDA 90688, held by Macleods Pharms. Nevirapine.
As of Nov 15, 2026, ANDA 90688 (Nevirapine), held by Macleods Pharms, was first approved by FDA on Jan 14, 2019, with 2 approved supplements and 0 published complete response letters.
Nevirapine tablets are 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 tablets is not recommended to be initiated, unless the benefit outweighs the risk, in:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Rx |
| Sep 21, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jun 7, 2023 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jan 14, 2019 | 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
