Details for New Drug Application (NDA): 203162
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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 203162
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203162
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 203162
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 203162 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-521 | 68382-521-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-521-01) |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 203162 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-521 | 68382-521-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-521-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 23MG | ||||
Approval Date: | Aug 31, 2017 | TE: | AB | RLD: | No |
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