Treats human immunodeficiency virus (HIV-1) infection. ANDA 77521, held by Aurobindo. Nevirapine.
As of Nov 15, 2026, ANDA 77521 (Nevirapine), held by Aurobindo, was first approved by FDA on May 22, 2012, with 6 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: 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 |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Rx |
| Mar 31, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| Dec 10, 2019 | Supplement 18Labeling · Standard review | Approved | None posted |
| Dec 10, 2019 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 20, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jan 20, 2015 | Supplement 16Labeling · Standard review | Approved | None posted |
| Feb 1, 2013 | Supplement 12Labeling · 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
