Orange Book product · Brand (NDA)
ARICEPT
DONEPEZIL HYDROCHLORIDE
At a glance
Nov 25, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 1996
30 yr ago
Today
Pharmaceutical detail
Active ingredient
DONEPEZIL HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020690
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022ADLARITYBrand (NDA)
NDA 212304 · CORIUM
- 2010ARICEPTBrand (NDA)
NDA 022568 · EISAI INC
- 2004ARICEPTBrand (NDA)
NDA 021719 · EISAI INC
- 2004ARICEPT ODTBrand (NDA)
NDA 021720 · EISAI INC
- 2018DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 205269 · HISUN PHARM HANGZHOU
- 2017DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204609 · CADILA PHARMS LTD
- 2017DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 202410 · HISUN PHARM HANGZHOU
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204831 · UNICHEM
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203656 · UNICHEM
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203419 · CHARTWELL RX
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203713 · DEXCEL
- 2016DONEPEZIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203114 · OSMOTICA PHARM US
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.
