Details for New Drug Application (NDA): 090686
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The generic ingredient in DONEPEZIL HYDROCHLORIDE 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 090686
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Torrent Pharms |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090686
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 090686
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090686 | ANDA | Major Pharmaceuticals | 0904-6477 | 0904-6477-61 | 100 BLISTER PACK in 1 CARTON (0904-6477-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090686 | ANDA | Major Pharmaceuticals | 0904-6478 | 0904-6478-61 | 100 BLISTER PACK in 1 CARTON (0904-6478-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 31, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 31, 2011 | TE: | AB | RLD: | No |
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