Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 89853, held by Aurobindo Pharma Ltd. Chlorzoxazone.
As of Nov 15, 2026, ANDA 89853 (Chlorzoxazone), held by Aurobindo Pharma Ltd, was first approved by FDA on May 4, 1988, with 5 approved supplements and 0 published complete response letters.
INDICATIONS 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 |
|---|---|---|---|
| May 4, 1988 | Original application | Approved | None posted |
| Chlorzoxazone500MG · tablet;oral | Chlorzoxazone | Rx |
| Chlorzoxazone375MG · tablet;oral | Chlorzoxazone | Rx |
| Chlorzoxazone750MG · tablet;oral | Chlorzoxazone | Rx |
| Aug 17, 2023 | Supplement 9Manufacturing | Approved | None posted |
| Jun 5, 1996 | Supplement 4Labeling | Approved | None posted |
| Dec 30, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Aug 1, 1989 | Supplement 2Labeling | Approved | None posted |
| Nov 4, 1988 | Supplement 1Manufacturing | Approved | None posted |
| May 4, 1988 | Original application | Approved | None posted |
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
