ANDA 212253, held by Novitium Pharma. Chlorzoxazone.
As of Nov 15, 2026, ANDA 212253 (Chlorzoxazone), held by Novitium Pharma, was first approved by FDA on Nov 27, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2019 | Original application | Approved |
| Chlorzoxazone375MG · tablet;oral | Chlorzoxazone | Rx |
| Chlorzoxazone750MG · tablet;oral | Chlorzoxazone | Rx |
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
