ANDA 88431, held by Cycle. Quinidine Gluconate.
As of Nov 15, 2026, ANDA 88431 (Quinidine Gluconate), held by Cycle, was first approved by FDA on Jan 6, 1984, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 6, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Quinidine Gluconate324MG 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
