Details for New Drug Application (NDA): 021487

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NDA 021487 describes NAMENDA, which is a drug marketed by Allergan and Abbvie and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and five Paragraph IV challenges. Additional details are available on the NAMENDA profile page.

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

Summary for 021487

Tradename:	NAMENDA
Applicant:	Abbvie
Ingredient:	memantine hydrochloride
Patents:	0

Pharmacology for NDA: 021487

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 021487

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 021487

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAMENDA	memantine hydrochloride	TABLET;ORAL	021487	NDA	Allergan, Inc.	0456-3200	0456-3200-14	1 KIT in 1 BLISTER PACK (0456-3200-14)
NAMENDA	memantine hydrochloride	TABLET;ORAL	021487	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-3870	0591-3870-44	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3870-44) / 10 TABLET in 1 BLISTER PACK (0591-3870-45)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 16, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 16, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021487

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-002	Oct 16, 2003	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMENDA	memantine hydrochloride	TABLET;ORAL	021487-001	Oct 16, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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