药品注册申请号：078895
申请类型：ANDA (仿制药申请)
申请人：UNICHEM
申请人全名：UNICHEM LABORATORIES LTD
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 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG No No AB 2009/08/26 2009/08/26 Prescription
002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG No No AB 2009/08/26 Prescription
003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG No Yes AB 2009/08/26 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
2009/08/26 ORIG-1（原始申请） Approval
>>>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
2013/01/17 SUPPL-7（补充） Approval Labeling-Package Insert STANDARD
2010/09/23 SUPPL-4（补充） Approval Labeling-Package Insert
2010/03/15 SUPPL-1（补充） Approval Labeling-Package Insert
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
无
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
无
与本品治疗等效的药品
>>>活性成分:CLONIDINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:0.1MG; 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
070974 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 1986/12/16 ACTAVIS ELIZABETH
070923 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 1987/09/04 TP ANDA HOLDINGS
071785 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 1988/04/05 CHARTWELL MOLECULES
070886 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 1988/08/31 AUROBINDO PHARMA LTD
077901 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 2007/03/09 PRINSTON INC
078895 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 2009/08/26 UNICHEM
078099 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 2009/08/27 IMPAX LABS
091368 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 2011/12/06 ALEMBIC PHARMS LTD
202297 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG Prescription No No AB 2013/06/13 YUNG SHIN PHARM
>>>活性成分:CLONIDINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:0.2MG; 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
070975 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 1986/12/16 ACTAVIS ELIZABETH
070923 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 1987/09/04 TP ANDA HOLDINGS
071785 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 1988/04/05 CHARTWELL MOLECULES
070886 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 1988/08/31 AUROBINDO PHARMA LTD
077901 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 2007/03/09 PRINSTON INC
078895 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 2009/08/26 UNICHEM
078099 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 2009/08/27 IMPAX LABS
091368 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 2011/12/06 ALEMBIC PHARMS LTD
202297 002 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG Prescription No No AB 2013/06/13 YUNG SHIN PHARM
>>>活性成分:CLONIDINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:0.3MG; 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
070976 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 1986/12/16 ACTAVIS ELIZABETH
070923 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 1987/09/04 TP ANDA HOLDINGS
071785 001 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 1988/04/05 CHARTWELL MOLECULES
070886 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 1988/08/31 AUROBINDO PHARMA LTD
077901 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 2007/03/09 PRINSTON INC
078895 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No Yes AB 2009/08/26 UNICHEM
078099 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 2009/08/27 IMPAX LABS
091368 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 2011/12/06 ALEMBIC PHARMS LTD
202297 003 ANDA CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG Prescription No No AB 2013/06/13 YUNG SHIN PHARM
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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