Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 22142, held by Mylan Labs Ltd. Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 22142 (Symfi), held by Mylan Labs Ltd, was first approved by FDA on Mar 22, 2018, with 1 approved supplement and 0 published complete response letters.
SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2018 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Symfi600MG;300MG;300MG · tablet;oral | Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2019 | Supplement 37Labeling · Standard review | Approved | |
| Mar 22, 2018 | Original applicationNew combination · Priority review | Approved |
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
