药品注册申请号:017771
申请类型:NDA (新药申请)
申请人:LANTHEUS MEDCL
申请人全名:LANTHEUS MEDICAL IMAGING 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 TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR SOLUTION;INTRAVENOUS 0.0083-2.7 CI/GENERATOR No No None 1976/11/16 Approved Prior to Jan 1, 1982 Discontinued
002 TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR SOLUTION;INTRAVENOUS 1-20 CI/GENERATOR Yes Yes None 2014/02/12 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
2016/11/15 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2016/02/12 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2015/08/27 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2014/02/12 SUPPL 35 Approval Labeling STANDARD
2012/11/16 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2009/03/25 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2007/12/07 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2004/09/02 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2001/12/05 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2000/12/06 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2000/08/11 SUPPL 19 Approval Labeling STANDARD
2000/02/29 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1998/02/04 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1997/12/15 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1997/11/05 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1996/04/05 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1996/01/24 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1996/01/11 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1995/05/23 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1993/08/12 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1993/01/12 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1985/04/29 SUPPL 9 Approval Labeling
1983/05/13 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1983/04/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1978/11/21 SUPPL 5 Approval Labeling
1978/10/11 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1978/06/07 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1976/11/16 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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