NDA 22459, held by Hetero Drugs Ltd. Lamivudine; Tenofovir.
As of Nov 14, 2026, NDA 22459 (Lamivudine/Tenofovir Disoproxil Fumarate Fdc Tabs), held by Hetero Drugs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2009 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine/Tenofovir Disoproxil Fumarate Fdc Tabs300MG/300MG · tablet; oral | Lamivudine; Tenofovir | 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
