药品注册申请号:015103
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
001 REGROTON CHLORTHALIDONE; RESERPINE TABLET;ORAL 50MG;0.25MG No No None 1964/05/08 Approved Prior to Jan 1, 1982 Discontinued
002 DEMI-REGROTON CHLORTHALIDONE; RESERPINE TABLET;ORAL 25MG;0.125MG No 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
1988/08/26 SUPPL 38 Approval Labeling STANDARD
1987/09/15 SUPPL 37 Approval Labeling STANDARD
1986/09/04 SUPPL 36 Approval Labeling STANDARD
1985/01/08 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1983/07/18 SUPPL 34 Approval Labeling STANDARD
1983/06/03 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1977/11/21 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1977/09/07 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1977/03/01 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1976/11/12 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1976/09/08 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1976/05/03 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1975/09/08 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1975/07/17 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1975/07/17 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1975/07/17 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1964/05/08 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)
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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