NDA 21988, held by Strides Acrolab. Lamivudine; Zidovudine; Nevirapine.
As of Nov 13, 2026, NDA 21988 (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets), held by Strides Acrolab, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2007 | Original applicationNew combination · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets150MG; 300MG; 200MG · tablet; oral | Lamivudine; Zidovudine; Nevirapine | None (tentative approval) |
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
