NDA 22293, held by Aurobindo Pharma. Abacavir Sulfate.
As of Nov 13, 2026, NDA 22293 (Abacavir Sulfate), held by Aurobindo Pharma, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2008 | Original applicationNew formulation or manufacturer · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abacavir Sulfate60MG · tablet; oral | Abacavir Sulfate | 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
