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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206858

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NDA 206858 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 206858

Tradename:	DALFAMPRIDINE
Applicant:	Rising
Ingredient:	dalfampridine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jul 6, 2020	TE:		RLD:	No

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