药品注册申请号:017466
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 BRICANYL TERBUTALINE SULFATE INJECTABLE;INJECTION 1MG/ML No No None 1974/03/25 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
2007/12/07 SUPPL 23 Approval Labeling STANDARD
2007/12/07 SUPPL 6 Approval Labeling
2007/12/07 SUPPL 5 Approval Efficacy
2007/12/07 SUPPL 2 Approval Labeling
1998/03/23 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1997/10/08 SUPPL 24 Approval Efficacy STANDARD
1989/05/30 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1988/02/03 SUPPL 21 Approval Labeling
1986/07/24 SUPPL 19 Approval Labeling
1985/06/25 SUPPL 18 Approval Labeling
1983/11/02 SUPPL 17 Approval Labeling
1983/03/01 SUPPL 16 Approval Labeling
1982/07/08 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1982/02/02 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1981/03/03 SUPPL 11 Approval Labeling
1981/01/19 SUPPL 13 Approval Labeling
1980/11/24 SUPPL 12 Approval Labeling
1979/11/09 SUPPL 10 Approval Labeling
1979/08/07 SUPPL 9 Approval Labeling
1978/10/12 SUPPL 8 Approval Labeling
1976/12/21 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1975/10/03 SUPPL 4 Approval Labeling
1975/07/21 SUPPL 3 Approval Manufacturing (CMC) PRIORITY
1974/03/25 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database