FDA Orange Book · active-ingredient family
Flecainide acetate
Flecainide acetate: 1 brand, 10 generics; first approved Oct 31, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
10
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- TAMBOCORRLDALVOGENNDA 01883019884 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- FLECAINIDE ACETATEOMSAV PHARMAANDA 21809320263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEYICHANG HUMANWELLANDA 21559920223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEREGCON HOLDINGSANDA 21068320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEAUROBINDO PHARMA LTDANDA 20282120173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATECHARTWELLANDA 07916420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - FLECAINIDE ACETATESUN PHARM INDS LTDANDA 07642120033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEHIKMAANDA 07627820033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEANI PHARMSANDA 07588220023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - FLECAINIDE ACETATEANI PHARMSANDA 07603020023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - FLECAINIDE ACETATEAMNEAL PHARMANDA 07544220013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
41 yr 5 mo ago
Most recent approval
4 mo ago
Approvals span 1985–2026 across 11 FDA applications.
Brand (NDA) 19%
Generic (ANDA) 1091%
Flecainide acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
