药品注册申请号:012383
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK AND CO 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 COLBENEMID COLCHICINE; PROBENECID TABLET;ORAL 0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1961/07/27 Approved Prior to Jan 1, 1982 Discontinued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
1994/08/18 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1994/04/20 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1989/11/30 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1988/05/12 SUPPL 24 Approval Labeling STANDARD
1988/05/12 SUPPL 23 Approval Labeling STANDARD
1988/05/12 SUPPL 21 Approval Labeling STANDARD
1985/07/23 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1982/03/02 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1981/08/21 SUPPL 14 Approval Labeling STANDARD
1979/08/24 SUPPL 16 Approval Labeling STANDARD
1979/05/30 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1979/05/10 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1978/06/01 SUPPL 13 Approval Labeling STANDARD
1961/07/27 ORIG 1 Approval Type 4 - New Combination 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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