ANDA 91210, held by Gate Pharms. Linezolid.
As of Nov 15, 2026, ANDA 91210 (Linezolid), held by Gate Pharms, was first approved by FDA on Feb 5, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG ยท tablet;oral | Linezolid | Discontinued |
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
