Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 213126, held by Rising. Chlorzoxazone.
As of Nov 15, 2026, ANDA 213126 (Chlorzoxazone), held by Rising, was first approved by FDA on Apr 5, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2022 | Original application | Approved | None posted |
| Chlorzoxazone375MG · tablet;oral | Chlorzoxazone | Rx |
| Chlorzoxazone500MG · 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
