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Details for New Drug Application (NDA): 020690

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NDA 020690 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from eight 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 drug master file entries for this compound. Fifty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for NDA: 020690

Tradename:
ARICEPT
Applicant:
Eisai Inc
Ingredient:
donepezil hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020690

Mechanism of ActionCholinesterase 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 NCS HealthCare of KY, Inc dba Vangard Labs 0615-7623 0615-7623-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7623-39)
ARICEPT
donepezil hydrochloride
TABLET;ORAL 020690 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7624 0615-7624-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7624-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 1996TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 1996TE:ABRLD:No

Expired Orange Book Patents for NDA: 020690

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 19964,895,841► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19964,895,841► subscribe
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