Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 212254, held by Novitium Pharma. Chlorzoxazone.
As of Nov 15, 2026, ANDA 212254 (Chlorzoxazone), held by Novitium Pharma, was first approved by FDA on Sep 12, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 |
|---|---|---|---|
| Sep 12, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorzoxazone500MG · 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
