NDA 18830, held by Alvogen. Flecainide Acetate.
As of Nov 13, 2026, NDA 18830 (Tambocor), held by Alvogen, was first approved by FDA on Oct 31, 1985, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 1985 | Original applicationNew molecular entity · Standard review | Approved |
| Tambocor100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Flecainide Acetate | DiscontinuedReference drug |
| Tambocor200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Flecainide Acetate | Discontinued |
| Tambocor150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Flecainide Acetate | DiscontinuedReference drug |
| Tambocor50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Flecainide Acetate | DiscontinuedReference drug |
| Sep 22, 2016 | Supplement 24Manufacturing · Standard review | Approved | |
| Apr 28, 2000 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1999 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1985 | Original applicationNew molecular entity · Standard review | Approved |
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
