药品注册申请号:017684
申请类型:NDA (新药申请)
申请人:PHARMALUCENCE
申请人全名:PHARMALUCENCE 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 PYROLITE TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT INJECTABLE;INJECTION N/A No No None 1976/11/19 Approved Prior to Jan 1, 1982 Discontinued
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
2000/05/02 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2000/02/07 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1998/12/17 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1998/03/23 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1997/06/13 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1989/06/26 SUPPL-14(补充) Approval Labeling STANDARD
1989/05/02 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1986/06/10 SUPPL-9(补充) Approval Efficacy STANDARD
1983/11/17 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1983/05/31 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1983/03/02 SUPPL-1(补充) Approval Efficacy STANDARD
1982/02/04 SUPPL-6(补充) Approval Labeling STANDARD
1980/08/11 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1976/11/19 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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