药品注册申请号:008732
申请类型:NDA (新药申请)
申请人:SHIRE
申请人全名:SHIRE DEVELOPMENT 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
002 PRO-BANTHINE PROPANTHELINE BROMIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1953/04/02 Approved Prior to Jan 1, 1982 Discontinued
003 PRO-BANTHINE PROPANTHELINE BROMIDE TABLET;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
1989/02/17 SUPPL 34 Approval Labeling
1988/02/11 SUPPL 33 Approval Labeling
1988/02/11 SUPPL 32 Approval Labeling
1988/02/11 SUPPL 29 Approval Labeling
1983/06/09 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1981/04/06 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1981/03/18 SUPPL 26 Approval Labeling
1981/03/18 SUPPL 25 Approval Labeling
1981/03/18 SUPPL 24 Approval Labeling
1981/03/18 SUPPL 21 Approval Labeling
1979/11/30 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1953/04/02 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)
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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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