Details for New Drug Application (NDA): 204831
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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-one suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 204831
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Unichem |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204831
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 204831
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 204831 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-250 | 29300-250-87 | 3 BLISTER PACK in 1 CARTON (29300-250-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-250-11) |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 204831 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-251 | 29300-251-87 | 3 BLISTER PACK in 1 CARTON (29300-251-87) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-251-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 10, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 10, 2016 | TE: | RLD: | No |
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