ANDA 218093, held by Micro Labs. Flecainide Acetate.
As of Nov 14, 2026, ANDA 218093 (Flecainide Acetate), held by Micro Labs, was first approved by FDA on Apr 22, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2026 | 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
