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FDA ANDA · ANDA075882

FLECAINIDE ACETATE

flecainide acetate tablet

Sponsor: ANI PHARMS

APPLICATION
ANDA075882
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-28
LATEST ACTION
2021-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 150MG · TABLET · ORAL
FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 50MG · TABLET · ORAL
FLECAINIDE ACETATEPrescription
FLECAINIDE ACETATE 100MG · TABLET · ORAL

Approval history

2021-11-03Manufacturing (CMC) · Supplement 13 · unknownAP
2002-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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