药品注册申请号:017538
申请类型:NDA (新药申请)
申请人:CURIUM
申请人全名:CURIUM US LLC
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 TECHNESCAN PYP KIT TECHNETIUM TC-99M PYROPHOSPHATE KIT INJECTABLE;INJECTION N/A No No AP 1974/05/28 Approved Prior to Jan 1, 1982 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
2017/03/21 SUPPL 19 Approval Labeling STANDARD
2013/11/25 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2007/02/26 SUPPL 15 Approval Manufacturing (CMC) N/A
1998/04/08 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/03/23 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1989/01/30 SUPPL 11 Approval Efficacy
1988/02/22 SUPPL 12 Approval Labeling
1984/05/21 SUPPL 10 Approval Labeling
1982/05/07 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1978/11/09 SUPPL 8 Approval Labeling
1978/11/09 SUPPL 7 Approval Labeling
1977/08/23 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1977/07/27 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1977/01/11 SUPPL 4 Approval Labeling
1976/01/13 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1974/05/28 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)
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
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
活性成分:TECHNETIUM TC-99M PYROPHOSPHATE KIT 剂型/给药途径:INJECTABLE;INJECTION 规格:N/A 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
017538 001 NDA TECHNESCAN PYP KIT TECHNETIUM TC-99M PYROPHOSPHATE KIT INJECTABLE;INJECTION N/A Prescription No No AP Approved Prior to Jan 1, 1982 CURIUM
019039 001 NDA CIS-PYRO TECHNETIUM TC-99M PYROPHOSPHATE KIT INJECTABLE;INJECTION N/A Prescription No No AP 1987/06/30 SUN PHARM INDS INC
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