药品注册申请号:020873
申请类型:NDA (新药申请)
申请人:SANDOZ INC
申请人全名:SANDOZ 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 ANGIOMAX BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Yes Yes AP 2000/12/15 2000/12/15 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
2019/07/02 SUPPL 39 Approval Labeling STANDARD
2018/12/21 SUPPL 37 Approval Labeling STANDARD
2016/05/10 SUPPL 33 Approval Manufacturing (CMC) STANDARD
2016/03/21 SUPPL 36 Approval Labeling STANDARD
2016/03/08 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2015/09/03 SUPPL 35 Approval Manufacturing (CMC) STANDARD
2015/05/29 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2014/08/07 SUPPL 31 Approval Manufacturing (CMC) STANDARD
2013/07/30 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2013/05/17 SUPPL 29 Approval Labeling STANDARD
2013/02/15 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2012/11/09 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2012/05/30 SUPPL 25 Approval Labeling UNKNOWN
2010/06/23 SUPPL 23 Approval Labeling STANDARD
2005/11/30 SUPPL 11 Approval Efficacy UNKNOWN
2005/09/02 SUPPL 14 Approval Labeling STANDARD
2005/06/13 SUPPL 6 Approval Efficacy STANDARD
2004/05/07 SUPPL 9 Approval Labeling STANDARD
2002/06/20 SUPPL 4 Approval Labeling STANDARD
2001/06/22 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2001/05/14 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/04/02 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2000/12/15 ORIG 1 Approval Type 1 - New Molecular Entity 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 7582727 2028/07/27 Y PDF格式
7582727*PED 2029/01/27 PDF格式
7598343 2028/07/27 Y PDF格式
7598343*PED 2029/01/27 PDF格式
001 5196404 2010/03/23 PDF格式**本条是由Drugfuture回溯的历史信息**
5196404 2014/12/15 Y Y U-1040 U-1232 PDF格式**本条是由Drugfuture回溯的历史信息**
5196404*PED 2015/06/15 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-458 2008/06/13**本条是由Drugfuture回溯的历史信息**
I-486 2008/11/30**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:BIVALIRUDIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:250MG/VIAL 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
020873 001 NDA ANGIOMAX BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription Yes Yes AP 2000/12/15 SANDOZ INC
090811 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2015/07/14 HOSPIRA INC
090816 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2015/07/14 HOSPIRA INC
090189 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2016/10/28 FRESENIUS KABI USA
201577 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2017/05/26 DR REDDYS LABS LTD
206551 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2017/11/22 ACCORD HLTHCARE
202471 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2018/06/01 MYLAN INSTITUTIONAL
091602 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2018/07/16 CIPLA
205962 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2018/07/27 AUROBINDO PHARMA LTD
210031 001 ANDA BIVALIRUDIN BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL Prescription No No AP 2019/10/23 SHUANGCHENG
更多信息
药品NDC数据与药品包装、标签说明书
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