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Details for New Drug Application (NDA): 020690
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The generic ingredient in ARICEPT 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 020690
Tradename: | ARICEPT |
Applicant: | Eisai Inc |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020690
Mechanism of Action | Cholinesterase 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 | PD-Rx Pharmaceuticals, Inc. | 55289-151 | 55289-151-21 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-151-21) |
ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690 | NDA | PD-Rx Pharmaceuticals, Inc. | 55289-151 | 55289-151-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-151-30) |
Paragraph IV (Patent) Challenges for 020690
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ARICEPT | TABLET;ORAL | donepezil hydrochloride | 020690 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 25, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 25, 1996 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020690
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | Start Trial | Start Trial |
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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