NDA 209670, held by Mylan Pharms Inc. Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 209670 (Dolutegravir, Lamivudine, And Tenofovir Disoproxil Fumarate), held by Mylan Pharms Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2017 | Original applicationNew combination · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dolutegravir, Lamivudine, And Tenofovir Disoproxil Fumarate50MG;300MG;300MG · tablet;oral | Dolutegravir;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
