FDA Orange Book · active-ingredient family
Flecainide acetate
Flecainide acetate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAMBOCOR · NDA 018830
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAMBOCORRLD×4 | ALVOGEN | NDA 018830 | — | Aug 23, 1988 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLECAINIDE ACETATE×3 | OMSAV PHARMA | ANDA 218093 | AB | Apr 22, 2026 | |
| FLECAINIDE ACETATE×3 | YICHANG HUMANWELL | ANDA 215599 | AB | Sep 08, 2022 | |
| FLECAINIDE ACETATE×3 | REGCON HOLDINGS | ANDA 210683 | AB | Sep 16, 2020 | |
| FLECAINIDE ACETATE×3 | AUROBINDO PHARMA LTD | ANDA 202821 | AB | Nov 03, 2017 | |
| FLECAINIDE ACETATE×3 | CHARTWELL | ANDA 079164 | — | Jul 09, 2009 | |
| FLECAINIDE ACETATE×3 | SUN PHARM INDS LTD | ANDA 076421 | AB | Mar 28, 2003 | |
| FLECAINIDE ACETATE×3 | HIKMA | ANDA 076278 | AB | Jan 14, 2003 | |
| FLECAINIDE ACETATE×3 | ANI PHARMS | ANDA 075882 | AB | Oct 28, 2002 | |
| FLECAINIDE ACETATE×3 | ANI PHARMS | ANDA 076030 | — | Oct 28, 2002 | |
| FLECAINIDE ACETATE×3 | AMNEAL PHARM | ANDA 075442 | AB | Jul 31, 2001 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Flecainide acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
