药品注册申请号:017478
申请类型:NDA (新药申请)
申请人:LANTHEUS MEDCL
申请人全名:LANTHEUS MEDICAL IMAGING 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 GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 INJECTABLE;INJECTION 2mCi/ML No No BS 1976/05/17 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
2018/08/06 SUPPL-16(补充) Approval Labeling STANDARD
2015/03/09 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2011/10/21 SUPPL-14(补充) Approval Labeling UNKNOWN
2004/03/03 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1987/01/02 SUPPL-11(补充) Approval Labeling
1984/07/31 SUPPL-7(补充) Approval Labeling
1983/08/15 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1982/07/12 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1979/11/21 SUPPL-4(补充) Approval Efficacy
1979/01/16 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/20 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1976/05/17 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:GALLIUM CITRATE GA-67 剂型/给药途径:INJECTABLE;INJECTION 规格:2mCi/ML 治疗等效代码:BS
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
017478 001 NDA GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 INJECTABLE;INJECTION 2mCi/ML Discontinued No No BS Approved Prior to Jan 1, 1982 LANTHEUS MEDCL
018058 001 NDA GALLIUM CITRATE GA 67 GALLIUM CITRATE GA-67 INJECTABLE;INJECTION 2mCi/ML Prescription No No BS Approved Prior to Jan 1, 1982 CURIUM
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database