Details for New Drug Application (NDA): 022525

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NDA 022525 describes NAMENDA XR, which is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the NAMENDA XR profile page.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for 022525

Tradename:	NAMENDA XR
Applicant:	Abbvie
Ingredient:	memantine hydrochloride
Patents:	1

Pharmacology for NDA: 022525

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 022525

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	14MG
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	21MG
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022525

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-002	Jun 21, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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