ANDA 88081, held by Chartwell Molecular. Quinidine Gluconate.
As of Nov 15, 2026, ANDA 88081 (Quinalan), held by Chartwell Molecular, was first approved by FDA on Feb 10, 1986, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Quinalan324MG ยท tablet, extended release;oral | Quinidine Gluconate | 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
