ANDA 212047, held by Somerset Theraps LLC. Chlorzoxazone.
As of Nov 15, 2026, ANDA 212047 (Chlorzoxazone), held by Somerset Theraps LLC, was first approved by FDA on Jan 27, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2023 | Original application | Approved | None posted |
| 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
