Orange Book product · Brand (NDA)
TAMBOCOR
FLECAINIDE ACETATE
At a glance
Aug 23, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 1988
38 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLECAINIDE ACETATE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018830
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026FLECAINIDE ACETATEGeneric (ANDA)
ANDA 218093 · OMSAV PHARMA
- 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.
