Details for New Drug Application (NDA): 020690

NDA 020690 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the ARICEPT profile page.

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

Summary for 020690

Tradename:	ARICEPT
Applicant:	Eisai Inc
Ingredient:	donepezil hydrochloride
Patents:	0

Pharmacology for NDA: 020690

Mechanism of Action

Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 020690

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690	NDA	Eisai Inc.	62856-245	62856-245-30	30 TABLET, FILM COATED in 1 BOTTLE (62856-245-30)
ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690	NDA	Eisai Inc.	62856-246	62856-246-30	30 TABLET, FILM COATED in 1 BOTTLE (62856-246-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 25, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 25, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020690

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996

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