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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021719

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NDA 021719 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 021719

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Oct 18, 2004	TE:		RLD:	Yes

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