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Last Updated: December 7, 2019

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Details for New Drug Application (NDA): 021720

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NDA 021720 describes ARICEPT ODT, which is a drug marketed by Eisai Inc and is included in one NDA. Additional details are available on the ARICEPT ODT profile page.

The generic ingredient in ARICEPT ODT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 021720
Tradename:ARICEPT ODT
Applicant:Eisai Inc
Ingredient:donepezil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021720
Mechanism of ActionCholinesterase Inhibitors
Paragraph IV (Patent) Challenges for 021720
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT ODT TABLET, ORALLY DISINTEGRATING;ORAL donepezil hydrochloride 021720 2010-06-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Oct 18, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Oct 18, 2004TE:RLD:Yes

Expired US Patents for NDA 021720

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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