ANDA 81008, held by Ferndale Labs. Chlorzoxazone.
As of Nov 15, 2026, ANDA 81008 (Strifon Forte Dsc), held by Ferndale Labs, was first approved by FDA on Dec 23, 1988, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Strifon Forte Dsc500MG ยท tablet;oral | Chlorzoxazone | Discontinued |
| Nov 20, 1991 | Supplement 1Manufacturing | Approved | None posted |
| Nov 20, 1991 | Supplement 2Manufacturing | Approved | None posted |
| Nov 20, 1991 | Supplement 3Labeling | Approved | None posted |
| Dec 23, 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