Details for New Drug Application (NDA): 206439

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NDA 206439 describes NAMZARIC, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAMZARIC profile page.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Summary for 206439

Tradename:	NAMZARIC
Applicant:	Abbvie
Ingredient:	donepezil hydrochloride; memantine hydrochloride
Patents:	12

Pharmacology for NDA: 206439

Mechanism of Action	Cholinesterase Inhibitors NMDA Receptor Antagonists

Suppliers and Packaging for NDA: 206439

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1207	0456-1207-30	30 CAPSULE in 1 BOTTLE (0456-1207-30)
NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1214	0456-1214-11	10 CAPSULE in 1 BLISTER PACK (0456-1214-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG;14MG
Approval Date:	Dec 23, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Patent:	⤷ Sign Up	Patent Expiration:	May 22, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 206439

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	⤷ Sign Up	⤷ Sign Up
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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