药品注册申请号:010598
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
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 BENDECTIN DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No None 1956/07/30 Approved Prior to Jan 1, 1982 Discontinued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
1982/12/09 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1982/09/07 SUPPL 13 Approval Labeling
1982/06/16 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1981/10/22 SUPPL 11 Approval Labeling
1981/10/22 SUPPL 10 Approval Labeling
1981/01/09 SUPPL 9 Approval Labeling
1979/11/06 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1979/07/25 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1978/11/01 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1978/08/01 SUPPL 5 Approval Labeling
1976/11/09 SUPPL 3 Approval Labeling
1976/11/09 SUPPL 2 Approval Efficacy
1956/07/30 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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药品NDC数据与药品包装、标签说明书
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