NDA 22085, held by Matrix Labs. Lamivudine; Stavudine.
As of Nov 14, 2026, NDA 22085 (Lamivudine; Stavudine), held by Matrix Labs, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2007 | Original applicationNew combination · Priority review | Tentative approval |
| Lamivudine; Stavudine150MG; 30MG · tablet; oral | Lamivudine; Stavudine | None (tentative approval) |
| Lamivudine; Stavudine150MG; 40MG · tablet; oral | Lamivudine; Stavudine | 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
