药品注册申请号：022331
申请类型：NDA (新药申请)
申请人：CONCORDIA PHARMS INC
申请人全名：CONCORDIA PHARMACEUTICALS 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 JENLOGA CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2009/09/29 2009/09/30 Discontinued
002 JENLOGA CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2010/05/25 Discontinued
003 KAPVAY CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Yes No AB1 2010/09/28 Discontinued
004 KAPVAY CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2010/09/28 Discontinued
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
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2020/02/06 SUPPL-21（补充） Approval Labeling STANDARD
2016/08/16 SUPPL-13（补充） Approval Labeling STANDARD
2016/07/20 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2016/05/03 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2015/06/05 SUPPL-15（补充） Approval Labeling STANDARD
2014/11/20 SUPPL-14（补充） Approval Efficacy STANDARD
2013/02/12 SUPPL-12（补充） Approval Labeling STANDARD
2010/09/28 SUPPL-5（补充） Approval Labeling STANDARD
2010/09/28 SUPPL-2（补充） Approval Efficacy STANDARD
2010/09/28 SUPPL-1（补充） Approval Efficacy STANDARD
2009/09/29 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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 5869100 2013/10/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 5869100 2013/10/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 5869100 2013/10/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 5869100 2013/10/13 Y 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
003 M-149 2017/11/20**本条是由Drugfuture回溯的历史信息**
NP 2013/09/28**本条是由Drugfuture回溯的历史信息**
004 M-149 2017/11/20**本条是由Drugfuture回溯的历史信息**
NP 2013/09/28**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:CLONIDINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:0.1MG 治疗等效代码:AB1
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
022331 003 NDA KAPVAY CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Discontinued Yes No AB1 2010/09/28 CONCORDIA PHARMS INC
202984 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Discontinued No No AB1 2013/09/30 ENDO OPERATIONS
203320 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No No AB1 2015/05/15 ACTAVIS ELIZABETH
209285 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No No AB1 2017/10/23 CHARTWELL RX
209686 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No Yes AB1 2017/11/20 AJANTA PHARMA LTD
209757 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No No AB1 2017/11/20 XIAMEN LP PHARM CO
210052 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Discontinued No No AB1 2017/11/20 AMNEAL PHARMS NY
210338 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No No AB1 2018/01/29 JUBILANT GENERICS
209675 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.1MG Prescription No No AB1 2019/03/05 NOVAST LABS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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