Details for New Drug Application (NDA): 022250

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NDA 022250 describes AMPYRA, which is a drug marketed by Merz and is included in one NDA. It is available from one supplier. Additional details are available on the AMPYRA profile page.

The generic ingredient in AMPYRA 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 022250

Tradename:	AMPYRA
Applicant:	Merz
Ingredient:	dalfampridine
Patents:	0

Pharmacology for NDA: 022250

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 022250

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250	NDA	Merz Pharmaceuticals, LLC	0259-5010	0259-5010-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)
AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250	NDA	Merz Pharmaceuticals, LLC	10144-427	10144-427-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jan 22, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022250

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Get Started Free	⤷ Get Started Free
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Get Started Free	⤷ Get Started Free
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Get Started Free	⤷ Get Started Free
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Get Started Free	⤷ Get Started Free
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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