Treats human immunodeficiency virus (HIV-1) infection. ANDA 77702, held by Aurobindo. Nevirapine.
As of Nov 15, 2026, ANDA 77702 (Nevirapine), held by Aurobindo, was first approved by FDA on May 22, 2012, with 6 approved supplements and 0 published complete response letters.
Nevirapine oral suspension 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 oral suspension 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 |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine50MG/5ML · suspension;oral | Nevirapine | Rx |
| Dec 12, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Dec 13, 2022 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jun 16, 2015 | Supplement 9Manufacturing | Approved | None posted |
| Feb 4, 2013 | Supplement 7Manufacturing | 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
