药品注册申请号:076362
申请类型:ANDA (仿制药申请)
申请人:TARO
申请人全名:TARO PHARMACEUTICAL INDUSTRIES 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 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG No No AB 2002/11/29 2002/11/29 Prescription
002 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 300MG No No None 2003/12/02 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2020/06/23 SUPPL 25 Approval Labeling STANDARD
2019/08/15 SUPPL 22 Approval Labeling STANDARD
2019/08/15 SUPPL 19 Approval Labeling STANDARD
2019/08/15 SUPPL 18 Approval Labeling STANDARD
2015/10/19 SUPPL 17 Approval Labeling STANDARD
2015/10/19 SUPPL 16 Approval Labeling STANDARD
2014/12/21 SUPPL 14 Approval Labeling STANDARD
2013/05/31 SUPPL 11 Approval Labeling
2013/05/31 SUPPL 10 Approval Labeling
2010/02/04 SUPPL 9 Approval Labeling
2009/06/02 SUPPL 8 Approval Labeling
2008/12/05 SUPPL 7 Approval Labeling
2005/06/07 SUPPL 6 Approval Labeling
2003/12/03 SUPPL 1 Approval Supplement
2003/12/02 SUPPL 2 Approval Labeling
2002/11/29 ORIG 1 Approval
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
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
与本品治疗等效的药品
活性成分:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:400MG 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
075315 002 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG Prescription No No AB 2000/06/30 SANDOZ
076362 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG Prescription No No AB 2002/11/29 TARO
077069 002 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG Prescription No No AB 2005/04/08 MURTY PHARMS
075389 003 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 400MG Prescription No No AB 2017/12/28 MAYNE PHARMA INC
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药品NDC数据与药品包装、标签说明书
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