NDA 21969, held by Cipla Limited. Lamivudine; Stavudine; Nevirapine.
As of Nov 14, 2026, NDA 21969 (Lamivudine; Stavudine; Nevirapine), held by Cipla Limited, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2006 | Original applicationNew combination · Priority review | Tentative approval |
| Lamivudine; Stavudine; Nevirapine150MG; 30MG; 200MG · tablet; oral | Lamivudine; Stavudine; Nevirapine | None (tentative approval) |
| Lamivudine; Stavudine; Nevirapine150MG; 40MG; 200MG · tablet; oral | Lamivudine; Stavudine; 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
