NDA 202381, held by Mylan Labs. Abacavir Sulfate; Lamivudine.
As of Nov 14, 2026, NDA 202381 (Abacavir Sulfate; Lamivudine), held by Mylan Labs, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2012 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir Sulfate; Lamivudine60MG; 30MG · tablet; oral | Abacavir Sulfate; 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
