NDA 22097, held by Strides Acrolab. Stavudine; Lamivudine; Efavirenz.
As of Nov 14, 2026, NDA 22097 (Stavudine; Lamivudine; Efavirenz), held by Strides Acrolab, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2007 | Original applicationNew combination · Priority review | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stavudine; Lamivudine; Efavirenz40MG; 150MG; 600MG · tablet; oral | Stavudine; Lamivudine; Efavirenz | 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
