Orange Book product · Generic (ANDA)
FLECAINIDE ACETATE
FLECAINIDE ACETATE
At a glance
Apr 22, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
FLECAINIDE ACETATE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218093
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLECAINIDE ACETATE
- 1988TAMBOCORBrand (NDA)
NDA 018830 · ALVOGEN
- 2022FLECAINIDE ACETATEGeneric (ANDA)
ANDA 215599 · YICHANG HUMANWELL
- 2020FLECAINIDE ACETATEGeneric (ANDA)
ANDA 210683 · REGCON HOLDINGS
- 2017FLECAINIDE ACETATEGeneric (ANDA)
ANDA 202821 · AUROBINDO PHARMA LTD
- 2009FLECAINIDE ACETATEGeneric (ANDA)
ANDA 079164 · CHARTWELL
- 2003FLECAINIDE ACETATEGeneric (ANDA)
ANDA 076421 · SUN PHARM INDS LTD
- 2003FLECAINIDE ACETATEGeneric (ANDA)
ANDA 076278 · HIKMA
- 2002FLECAINIDE ACETATEGeneric (ANDA)
ANDA 075882 · ANI PHARMS
- 2002FLECAINIDE ACETATEGeneric (ANDA)
ANDA 076030 · ANI PHARMS
- 2001FLECAINIDE ACETATEGeneric (ANDA)
ANDA 075442 · AMNEAL PHARM
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.
