Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 22141, held by Mylan Labs Ltd. Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 22141 (Cimduo), held by Mylan Labs Ltd, was first approved by FDA on Feb 28, 2018, with 1 approved supplement and 0 published complete response letters.
CIMDUO (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2018 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cimduo300MG;300MG · tablet;oral | Lamivudine; Tenofovir Disoproxil Fumarate | RxReference drug |
| Jul 10, 2018 | Supplement 24 | Approved | |
| Feb 28, 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
