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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 208292

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NDA 208292 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 208292

Tradename:	DALFAMPRIDINE
Applicant:	Sun Pharm
Ingredient:	dalfampridine
Patents:	0

Pharmacology for NDA: 208292

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 208292

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	208292	ANDA	Sun Pharmaceutical Industries, Inc.	62756-429	62756-429-86	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	May 21, 2019	TE:	AB	RLD:	No

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