NDA 212527, held by Cipla USA Inc.. Dolutegravir Lamivudine Tenofovir Alafenamide.
As of Nov 14, 2026, NDA 212527 (Dolutegravir Lamivudine Tenofovir Alafenamide), held by Cipla USA Inc., was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2022 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dolutegravir Lamivudine Tenofovir AlafenamideEQ 50MG BASE; 300MG; 25MG · tablet | Dolutegravir Lamivudine Tenofovir Alafenamide | 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
