ANDA 40861, held by Pharmobedient. Chlorzoxazone.
As of Nov 15, 2026, ANDA 40861 (Chlorzoxazone), held by Pharmobedient, was first approved by FDA on Jun 1, 2010, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2010 | Original application | Approved |
| Chlorzoxazone375MG · tablet;oral | Chlorzoxazone | Rx |
| Chlorzoxazone750MG · tablet;oral | Chlorzoxazone | Rx |
| Mar 13, 2014 | Supplement 2Labeling | Approved | None posted |
| Jun 1, 2010 | Original application | Approved |
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
