Memantine and Donepezil

FDA Drug Profile — Memantine and Donepezil, Memantine and Donepezil Hydrochlorides Extended-release

Drug Details

Generic Name
Memantine and Donepezil
Brand Names
Memantine and Donepezil, Memantine and Donepezil Hydrochlorides Extended-release
Application Number
ANDA208672
Sponsor
Macleods Pharmaceuticals Limited
NDC Codes
7
Dosage Forms
CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. (1)