药品注册申请号:019044
申请类型:NDA (新药申请)
申请人:GE HEALTHCARE
申请人全名:GE HEALTHCARE
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 INDIUM IN 111 OXYQUINOLINE INDIUM IN-111 OXYQUINOLINE INJECTABLE;INJECTION 1mCi/ML Yes Yes AP 1985/12/24 1985/12/24 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
2022/12/12 SUPPL-25(补充) Approval Labeling STANDARD
2014/07/07 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
2013/11/08 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
2002/09/19 SUPPL-18(补充) Approval Labeling STANDARD
2000/08/02 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1999/08/30 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1997/10/16 SUPPL-15(补充) Approval Labeling STANDARD
1995/08/11 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/11 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/11 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1995/01/13 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1990/08/27 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1990/08/08 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1990/08/08 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1989/12/12 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1989/04/11 SUPPL-5(补充) Approval Labeling
1987/06/08 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1985/12/24 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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:INDIUM IN-111 OXYQUINOLINE 剂型/给药途径:INJECTABLE;INJECTION 规格:1mCi/ML 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
019044 001 NDA INDIUM IN 111 OXYQUINOLINE INDIUM IN-111 OXYQUINOLINE INJECTABLE;INJECTION 1mCi/ML Prescription Yes Yes AP 1985/12/24 GE HEALTHCARE
202586 001 ANDA INDIUM IN 111 OXYQUINOLINE INDIUM IN-111 OXYQUINOLINE INJECTABLE;INJECTION 1mCi/ML Prescription No No AP 2018/07/25 BWXT ITG
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