药品注册申请号:018310
申请类型:NDA (新药申请)
申请人:COVIDIEN
申请人全名:COVIDIEN
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 LYMPHAZURIN ISOSULFAN BLUE SOLUTION;SUBCUTANEOUS 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1981/07/29 Approved Prior to Jan 1, 1982 Discontinued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
2007/10/29 SUPPL-11(补充) Approval Labeling STANDARD
2001/07/26 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1995/10/18 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1990/07/13 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1987/10/22 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1987/10/22 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1983/05/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1982/07/27 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1982/02/17 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/07/29 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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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