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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 210683

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NDA 210683 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Chartwell, Hikma, Regcon Holdings, Sun Pharm Inds Ltd, and Yichang Humanwell, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the FLECAINIDE ACETATE profile page.

The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

Summary for 210683

Tradename:	FLECAINIDE ACETATE
Applicant:	Regcon Holdings
Ingredient:	flecainide acetate
Patents:	0

Pharmacology for NDA: 210683

Medical Subject Heading (MeSH) Categories for 210683

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 210683

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683	ANDA	Bryant Ranch Prepack	71335-2577	71335-2577-1	30 TABLET in 1 BOTTLE (71335-2577-1)
FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	210683	ANDA	Bryant Ranch Prepack	71335-2577	71335-2577-2	60 TABLET in 1 BOTTLE (71335-2577-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 16, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 16, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Sep 16, 2020	TE:	AB	RLD:	No

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