NDA 205355, held by Hetero Labs Ltd Iii. Lamivudine; Tenofovir Disoproxil Fumarate; Nevirapine.
As of Nov 15, 2026, NDA 205355 (Lamivudine; Tenofovir Disoproxil Fumarate; Nevirapine), held by Hetero Labs Ltd Iii, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2014 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine; Tenofovir Disoproxil Fumarate; Nevirapine300MG; 300MG; 200MG · tablet; oral | Lamivudine; Tenofovir Disoproxil Fumarate; 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
