NDA 217070, held by Aurobindo Pharma USA. Abacavir; Dolutegravir; Lamivudine.
As of Nov 14, 2026, NDA 217070 (Abacavir; Dolutegravir; Lamivudine), held by Aurobindo Pharma USA, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2023 | Original applicationNew formulation or manufacturer · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir; Dolutegravir; Lamivudine60MG;5MG;30MG · tablet; oral | Abacavir; Dolutegravir; Lamivudine | 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
