NDA 215187, held by Lupin Pharms. Dolutegravir;Lamivudine;Tenofovir Alafenamide.
As of Nov 14, 2026, NDA 215187 (Dolutegravir;Lamivudine;Tenofovir Alafenamide), held by Lupin Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2023 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dolutegravir;Lamivudine;Tenofovir Alafenamide50MG;300MG;25MG · tablet; oral | 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
