ANDA 81019, held by Watson Labs. Chlorzoxazone.
As of Nov 15, 2026, ANDA 81019 (Chlorzoxazone), held by Watson Labs, was first approved by FDA on Jul 29, 1991, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 1991 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorzoxazone500MG ยท tablet;oral | Chlorzoxazone | Discontinued |
| Apr 7, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Mar 21, 1996 | Supplement 1Labeling | Approved | None posted |
| Jul 29, 1991 | 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
