Treats human immunodeficiency virus (HIV-1) infection. ANDA 78584, held by Hetero Labs Ltd Iii. Nevirapine.
As of Nov 15, 2026, ANDA 78584 (Nevirapine), held by Hetero Labs Ltd Iii, was first approved by FDA on May 22, 2012, with 5 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 are 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/mm3.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Rx |
| Oct 23, 2024 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jun 24, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jun 24, 2020 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 20, 2013 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 14, 2012 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 22, 2012 | 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
