NDA 219804, held by Aspen SA Operations (Pty) Ltd. Dolutegravir; Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 14, 2026, NDA 219804 (DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE), held by Aspen SA Operations (Pty) Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2026 | Original applicationNew combination · Standard 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
