Assyro AI

Orange Book product · Generic (ANDA)

FLECAINIDE ACETATE

FLECAINIDE ACETATE

Generic (ANDA)ANDA 076421TE ABRX SUN PHARM INDS LTD

At a glance

Mar 28, 2003

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 28, 2003

    23 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLECAINIDE ACETATE

Strength

50MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 076421

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FLECAINIDE ACETATE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.