NDA 210649, held by Macleods Pharms. Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 210649 (Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate), held by Macleods Pharms, was first approved by FDA on Mar 15, 2019, with 0 approved supplements and 2 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2019 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 12, 2018 | NDA 210649Facility Inspections | Approved |
| Mar 13, 2018 | NDA 210649Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate400MG;300MG;300MG · tablet;oral | Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | Discontinued |
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
