NDA 215448, held by Aurobindo Pharma USA. DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE.
As of Nov 13, 2026, NDA 215448 (DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE), held by Aurobindo Pharma USA, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2023 | Original applicationNew combination · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE50MG/200MG/25MG · tablet; oral | DOLUTEGRAVIR, EMTRICITABINE and 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
