ANDA 76421, held by Sun Pharm Inds Ltd. Flecainide Acetate.
As of Nov 14, 2026, ANDA 76421 (Flecainide Acetate), held by Sun Pharm Inds Ltd, was first approved by FDA on Mar 28, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2003 | Original application | Approved | None posted |
| Flecainide Acetate50MG · tablet;oral | Flecainide Acetate | Rx |
| Flecainide Acetate100MG · tablet;oral | Flecainide Acetate | Rx |
| Flecainide Acetate150MG · tablet;oral | Flecainide Acetate | Rx |
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