Orange Book product · Generic (ANDA)
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
At a glance
Feb 27, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Strength
10MG;7MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 208328
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
- 2016NAMZARICBrand (NDA)
NDA 206439 · ABBVIE
- 2025MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 208672 · MACLEODS PHARMS LTD
- 2025MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 216901 · XIAMEN LP PHARM CO
- 2023MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 208237 · ANI PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
