memantine hydrochloride and donepezil hydrochloride

FDA Drug Profile — memantine hydrochloride and donepezil hydrochloride, Namzaric

Drug Details

Generic Name
memantine hydrochloride and donepezil hydrochloride
Brand Names
memantine hydrochloride and donepezil hydrochloride, Namzaric
Application Number
ANDA216901
Sponsor
Vitruvias Therapeutics, Inc.
NDC Codes
11
Dosage Forms
CAPSULE, EXTENDED RELEASE, CAPSULE, KIT
Routes
ORAL
Active Ingredients
DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE NAMZARIC is 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. NAMZARIC is 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 )