Details for New Drug Application (NDA): 201787
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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 201787
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201787
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 201787
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 201787 | ANDA | Macleods Pharmaceuticals Limited | 33342-029 | 33342-029-06 | 3 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 201787 | ANDA | Macleods Pharmaceuticals Limited | 33342-029 | 33342-029-07 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 14, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 14, 2012 | TE: | AB | RLD: | No |
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