Details for New Drug Application (NDA): 022568
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The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight 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 |
Pharmacology for NDA: 022568
Mechanism of Action | Cholinesterase 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: | RX | Dosage: | TABLET;ORAL | Strength | 23MG | ||||
Approval Date: | Jul 23, 2010 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 4, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022568
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 022568-001 | Jul 23, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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