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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076421

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NDA 076421 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, 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 076421

Tradename:	FLECAINIDE ACETATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	flecainide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076421

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 28, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 28, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Mar 28, 2003	TE:	AB	RLD:	No

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