NDA 22541, held by Macleods Pharma. Lamivudine; Stavudine.
As of Nov 14, 2026, NDA 22541 (Lamivudine And Stavudine), held by Macleods Pharma, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 5, 2010 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine And Stavudine150MG; 30MG · 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
