Last Updated: September 27, 2026

Details for New Drug Application (NDA): 206646

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NDA 206646 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 is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

Summary for 206646

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Oct 24, 2018	TE:		RLD:	No

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