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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/01/20 SUPPL-44(补充) Approval Labeling STANDARD
2016/11/15 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
2016/02/12 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2015/08/27 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
2014/02/12 SUPPL-35(补充) Approval Labeling STANDARD
2012/11/16 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2009/03/25 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2007/12/07 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2004/09/02 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2001/12/05 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2000/12/06 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2000/08/11 SUPPL-19(补充) Approval Labeling STANDARD
2000/02/29 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1998/02/04 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1997/12/15 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1997/11/05 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1996/04/05 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1996/01/24 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1996/01/11 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1995/05/23 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1993/08/12 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1993/01/12 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1985/04/29 SUPPL-9(补充) Approval Labeling
1983/05/13 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1983/04/18 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1978/11/21 SUPPL-5(补充) Approval Labeling
1978/10/11 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1978/06/07 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1976/11/16 ORIG-1(原始申请) 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
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
本品无治疗等效药品
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