药品注册申请号:018107
申请类型:NDA (新药申请)
申请人:CARDINAL HEALTH 414
申请人全名:CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES
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 TECHNETIUM TC-99M MEDRONATE KIT TECHNETIUM TC-99M MEDRONATE KIT INJECTABLE;INJECTION N/A No No AP 1981/02/17 Approved Prior to Jan 1, 1982 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
2020/11/13 SUPPL-15(补充) Approval Labeling STANDARD
2015/09/10 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2014/02/21 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2008/11/26 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1999/11/23 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1997/03/04 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1994/03/21 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1993/03/24 SUPPL-6(补充) Approval Labeling
1993/03/24 SUPPL-3(补充) Approval Labeling
1992/09/30 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1985/09/30 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1982/04/12 SUPPL-2(补充) Approval Labeling
1981/04/13 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/02/17 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)
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 MEDRONATE 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
018107 001 NDA TECHNETIUM TC-99M MEDRONATE KIT TECHNETIUM TC-99M MEDRONATE KIT INJECTABLE;INJECTION N/A Prescription No No AP Approved Prior to Jan 1, 1982 CARDINAL HEALTH 414
018124 001 NDA CIS-MDP TECHNETIUM TC-99M MEDRONATE KIT INJECTABLE;INJECTION N/A Prescription No No AP Approved Prior to Jan 1, 1982 SUN PHARM INDS INC
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