Orange Book product · Generic (ANDA)
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE
At a glance
Nov 10, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DONEPEZIL HYDROCHLORIDE
Strength
5MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
ANDA 204831
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DONEPEZIL HYDROCHLORIDE
- 2022ADLARITYBrand (NDA)
NDA 212304 · CORIUM
- 2010ARICEPTBrand (NDA)
NDA 022568 · EISAI INC
- 2004ARICEPTBrand (NDA)
NDA 021719 · EISAI INC
- 2004ARICEPT ODTBrand (NDA)
NDA 021720 · EISAI INC
- 1996ARICEPTBrand (NDA)
NDA 020690 · 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 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.
