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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 022250


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NDA 022250 describes AMPYRA, which is a drug marketed by Merz Pharms 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. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 022250
Tradename:AMPYRA
Applicant:Merz Pharms
Ingredient:dalfampridine
Patents:0
Pharmacology for NDA: 022250
Mechanism of ActionPotassium 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, a subsidiary of Merz Therapeutics GmbH 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 22, 2010TE:ABRLD:Yes

Expired US Patents for NDA 022250

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

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