Details for New Drug Application (NDA): 201146
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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 201146
Tradename: | DONEPEZIL HYDROCHLORIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | donepezil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201146
Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 201146
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 201146 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7951 | 0615-7951-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05) |
DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 201146 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7951 | 0615-7951-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 17, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 17, 2012 | TE: | AB | RLD: | No |
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