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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 206836

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NDA 206836 describes DALFAMPRIDINE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma, Hikma, Micro Labs, Rising, and Sun Pharm, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DALFAMPRIDINE profile page.

The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

Summary for 206836

Tradename:	DALFAMPRIDINE
Applicant:	Actavis Labs Fl Inc
Ingredient:	dalfampridine
Patents:	0

Pharmacology for NDA: 206836

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 206836

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206836	ANDA	Actavis Pharma, Inc.	0591-2533	0591-2533-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2533-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jan 23, 2017	TE:	AB	RLD:	No

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