药品注册申请号:013731
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 BILOPAQUE TYROPANOATE SODIUM CAPSULE;ORAL 750MG No No None 1969/10/24 Approved Prior to Jan 1, 1982 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
1995/02/22 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1991/02/21 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1990/02/21 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1988/02/22 SUPPL 28 Approval Labeling STANDARD
1987/05/20 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1986/07/18 SUPPL 26 Approval Labeling STANDARD
1986/07/11 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1984/11/07 SUPPL 24 Approval Labeling STANDARD
1984/07/11 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1984/02/01 SUPPL 21 Approval Labeling STANDARD
1982/06/30 SUPPL 20 Approval Labeling STANDARD
1982/02/08 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1980/01/25 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1979/10/29 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1979/05/14 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1978/12/28 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1978/10/30 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1977/06/15 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1977/06/08 SUPPL 12 Approval Labeling STANDARD
1976/05/11 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1969/10/24 ORIG 1 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
更多信息
药品NDC数据与药品包装、标签说明书
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