药品注册申请号：020690
申请类型：NDA (新药申请)
申请人：EISAI INC
申请人全名：EISAI INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Yes Yes AB 1996/11/25 1996/11/25 Prescription
002 ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Yes No AB 1996/11/25 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1996/11/25 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/12/18 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2015/07/20 SUPPL-39（补充） Approval Labeling-Package Insert STANDARD
2013/09/06 SUPPL-37（补充） Approval Labeling-Package Insert STANDARD
2013/04/04 SUPPL-31（补充） Approval Labeling-Container/Carton Labels STANDARD
2012/09/04 SUPPL-36（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2012/03/07 SUPPL-35（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2010/12/02 SUPPL-33（补充） Approval Labeling STANDARD
2006/10/13 SUPPL-26（补充） Approval Efficacy-New Indication UNKNOWN
2004/05/04 SUPPL-11（补充） Approval Labeling STANDARD
2002/01/07 SUPPL-19（补充） Approval Manufacturing (CMC) PRIORITY
2002/01/07 SUPPL-18（补充） Approval Manufacturing (CMC) PRIORITY
2001/10/03 SUPPL-17（补充） Approval Manufacturing (CMC)-Control PRIORITY
2001/06/20 SUPPL-16（补充） Approval Labeling STANDARD
2000/09/21 SUPPL-15（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
2000/03/28 SUPPL-13（补充） Approval Manufacturing (CMC) PRIORITY
2000/02/28 SUPPL-12（补充） Approval Labeling STANDARD
2000/02/28 SUPPL-8（补充） Approval Labeling STANDARD
1999/08/18 SUPPL-10（补充） Approval Manufacturing (CMC) PRIORITY
1999/02/10 SUPPL-9（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1998/11/04 SUPPL-7（补充） Approval Manufacturing (CMC) PRIORITY
1998/10/16 SUPPL-6（补充） Approval Manufacturing (CMC) PRIORITY
1998/08/18 SUPPL-5（补充） Approval Labeling STANDARD
1998/08/13 SUPPL-4（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1998/08/13 SUPPL-3（补充） Approval Manufacturing (CMC)-Control PRIORITY
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 4895841 2010/11/25 PDF格式**本条是由Drugfuture回溯的历史信息**
5985864 2016/12/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6140321 2016/12/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6245911 2018/12/01 PDF格式**本条是由Drugfuture回溯的历史信息**
6372760 2019/03/31 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4895841 2010/11/25 PDF格式**本条是由Drugfuture回溯的历史信息**
5985864 2016/12/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6140321 2016/12/30 PDF格式**本条是由Drugfuture回溯的历史信息**
6245911 2018/12/01 PDF格式**本条是由Drugfuture回溯的历史信息**
6372760 2019/03/31 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-529 2009/10/13**本条是由Drugfuture回溯的历史信息**
002 I-529 2009/10/13**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:DONEPEZIL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020690 001 NDA ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes Yes AB 1996/11/25 EISAI INC
077518 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 CIPLA LTD
078662 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 STRIDES PHARMA
090056 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 AUROBINDO
090290 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2011/05/31 AIPING PHARM INC
090425 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 CHARTWELL RX
090493 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2011/05/31 SUN PHARM INDS
090551 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 NOVITIUM PHARMA
090686 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 TORRENT PHARMS
090768 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 JUBILANT GENERICS
200292 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 PRINSTON INC
201001 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/05/31 DR REDDYS LABS LTD
201634 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2012/06/13 INDICUS PHARMA
201146 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2012/08/17 MACLEODS PHARMS LTD
090100 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2012/10/24 ZYDUS LIFESCIENCES
201724 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2013/02/25 ALEMBIC PHARMS LTD
202114 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2013/07/05 RISING
203907 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/10/29 SCIEGEN PHARMS INC
203034 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/01/30 HETERO LABS LTD V
204609 002 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/09/19 CADILA PHARMS LTD
>>>活性成分:DONEPEZIL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:5MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020690 002 NDA ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB 1996/11/25 EISAI INC
077518 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 CIPLA LTD
078662 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 STRIDES PHARMA
090056 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 AUROBINDO
090290 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2011/05/31 AIPING PHARM INC
090425 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 CHARTWELL RX
090493 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2011/05/31 SUN PHARM INDS
090551 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 NOVITIUM PHARMA
090686 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 TORRENT PHARMS
090768 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 JUBILANT GENERICS
200292 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 PRINSTON INC
201001 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/05/31 DR REDDYS LABS LTD
201634 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2012/06/13 INDICUS PHARMA
201146 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/08/17 MACLEODS PHARMS LTD
090100 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/10/24 ZYDUS LIFESCIENCES
201724 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2013/02/25 ALEMBIC PHARMS LTD
202114 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2013/07/05 RISING
203907 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/10/29 SCIEGEN PHARMS INC
203034 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/01/30 HETERO LABS LTD V
204609 001 ANDA DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/09/19 CADILA PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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