NDA 205861, held by Macleods Pharms Ltd. Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate.
As of Nov 14, 2026, NDA 205861 (Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate), held by Macleods Pharms Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2014 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate600MG;300MG;300MG · tablet;oral | Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate | 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
