ANDA 76234, held by Impax Pharms. Flavoxate Hydrochloride.
As of Nov 15, 2026, ANDA 76234 (Flavoxate Hydrochloride), held by Impax Pharms, was first approved by FDA on Aug 28, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flavoxate Hydrochloride100MG ยท tablet;oral | Flavoxate Hydrochloride | Discontinued |
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
