药品注册申请号:017714
申请类型:NDA (新药申请)
申请人:JUBILANT DRAXIMAGE
申请人全名:JUBILANT DRAXIMAGE 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 AN-DTPA TECHNETIUM TC-99M PENTETATE KIT INJECTABLE;INJECTION N/A No No None 1976/11/16 Approved Prior to Jan 1, 1982 Discontinued
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
2002/12/12 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2002/03/20 SUPPL 21 Approval Labeling STANDARD
1997/05/27 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1993/02/23 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1986/04/02 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1986/01/27 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1985/08/02 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1985/04/29 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1984/03/23 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1983/06/03 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1982/06/30 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1979/03/07 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1979/03/07 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1979/03/07 SUPPL 1 Approval Labeling
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
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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