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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206765

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NDA 206765 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

Summary for 206765

Tradename:	DALFAMPRIDINE
Applicant:	Alkem Labs Ltd
Ingredient:	dalfampridine
Patents:	0

Pharmacology for NDA: 206765

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 206765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206765	ANDA	Golden State Medical Supply, Inc.	51407-876	51407-876-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-876-60)
DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206765	ANDA	Bryant Ranch Prepack	63629-9450	63629-9450-1	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9450-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jul 30, 2018	TE:	AB	RLD:	No

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