NDA 202007, held by Cipla Limited. Abacavir Sulfate; Lamivudine.
As of Nov 14, 2026, NDA 202007 (Abacavir Sulfate; Lamivudine), held by Cipla Limited, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2011 | Original applicationNew formulation or manufacturer · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir Sulfate; Lamivudine60MG; 30MG · tablet, for suspension; 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
