Treats moderate to severe dementia of the Alzheimer’s type. NDA 206439, held by Abbvie. Donepezil Hydrochloride; Memantine Hydrochloride.
As of Nov 13, 2026, NDA 206439 (Namzaric), held by Abbvie, was first approved by FDA on Dec 23, 2014, with 3 approved supplements and 0 published complete response letters.
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.
| Jul 18, 2016 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 2014 | Original applicationNew combination · Standard review | Approved |
| Namzaric10MG;14MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | RxReference drug |
| Namzaric10MG;28MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | RxReference drug |
| Namzaric10MG;7MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | RxReference drug |
| Namzaric10MG;21MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | RxReference drug |
| Jul 18, 2016 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 1, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 23, 2014 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
