药品注册申请号:021858
申请类型:NDA (新药申请)
申请人:ROCHE
申请人全名:HOFFMANN LA ROCHE 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 BONIVA IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Yes Yes AP 2006/01/06 2006/01/06 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
2016/12/07 SUPPL 22 Approval Labeling STANDARD
2015/07/22 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2015/05/04 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2015/04/08 SUPPL 20 Approval Labeling STANDARD
2015/03/18 SUPPL 19 Approval Labeling STANDARD
2014/10/20 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2014/09/08 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2014/06/18 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL 14 Approval Labeling STANDARD
2013/04/19 SUPPL 13 Approval Labeling STANDARD
2013/04/19 SUPPL 8 Approval Labeling STANDARD
2011/08/10 SUPPL 10 Approval Labeling UNKNOWN
2011/07/01 SUPPL 12 Approval REMS N/A
2011/01/25 SUPPL 9 Approval REMS N/A
2007/02/12 SUPPL 4 Approval Labeling STANDARD
2006/08/07 SUPPL 1 Approval Labeling STANDARD
2006/01/06 ORIG 1 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 4927814 2012/03/17 Y Y U-700 PDF格式**本条是由Drugfuture回溯的历史信息**
5662918 2014/09/02 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
001 NCE 2008/05/16**本条是由Drugfuture回溯的历史信息**
NDF 2009/01/06**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:IBANDRONATE SODIUM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 3MG BASE/3ML 治疗等效代码:AP
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
021858 001 NDA BONIVA IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription Yes Yes AP 2006/01/06 ROCHE
090853 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2014/02/14 SUN PHARM
202235 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2014/09/02 SAGENT PHARMS INC
202671 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2014/09/02 MYLAN LABS LTD
205332 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2015/08/19 AUROBINDO PHARMA LTD
204222 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2015/10/16 APOTEX
206058 001 ANDA IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML Prescription No No AP 2016/02/05 ACCORD HLTHCARE
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药品NDC数据与药品包装、标签说明书
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