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Generated: November 20, 2018

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Details for New Drug Application (NDA): 022568

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NDA 022568 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from four suppliers. 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 022568
Tradename:ARICEPT
Applicant:Eisai Inc
Ingredient:donepezil hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022568
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 022568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARICEPT donepezil hydrochloride TABLET;ORAL 022568 NDA Eisai Inc. 62856-247 62856-247-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-247-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength23MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Chinese Patent Office
Fish and Richardson
Dow
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Queensland Health
Teva
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US Army

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