Details for New Drug Application (NDA): 204293
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The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 204293
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204293
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 204293
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 204293 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-194 | 62756-194-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18) |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 204293 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-194 | 62756-194-81 | 90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 23MG | ||||
Approval Date: | Jun 5, 2015 | TE: | RLD: | No |
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