Treats HIV-1 infection. ANDA 78195, held by Strides Pharma. Nevirapine.
As of Nov 15, 2026, ANDA 78195 (Nevirapine), held by Strides Pharma, was first approved by FDA on May 22, 2012, with 1 approved supplement and 0 published complete response letters.
Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine200MG · tablet;oral | Nevirapine | Discontinued |
| Jan 2, 2020 | Supplement 13Labeling · 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
