NDA 22346, held by Pharmacare Ltd. Stavudine; Lamivudine; Nevirapine.
As of Nov 13, 2026, NDA 22346 (Stavudine; Lamivudine; Nevirapine), held by Pharmacare Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2009 | Original applicationNew combination · Standard review | Tentative approval |
| Stavudine; Lamivudine; Nevirapine30MG; 150MG; 200MG · tablet; oral | Stavudine; Lamivudine; Nevirapine | None (tentative approval) |
| Stavudine; Lamivudine; Nevirapine40MG; 150MG; 200MG · tablet; oral | Stavudine; Lamivudine; 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
