药品注册申请号:007409
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN SALES 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 BENTYL DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Yes No None 1950/05/11 1984/10/15 Discontinued
003 BENTYL DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Yes No None 1984/10/15 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
2013/01/11 SUPPL 42 Approval Labeling STANDARD
2011/08/01 SUPPL 41 Approval Labeling UNKNOWN
2007/02/02 SUPPL 40 Approval Labeling STANDARD
1999/08/17 SUPPL 39 Approval Labeling STANDARD
1996/09/09 SUPPL 38 Approval Labeling STANDARD
1993/01/04 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1992/06/24 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1991/10/29 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1990/09/25 SUPPL 34 Approval Labeling
1990/03/15 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1989/08/04 SUPPL 16 Approval Labeling
1989/06/15 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1987/09/28 SUPPL 26 Approval Labeling
1987/02/06 SUPPL 29 Approval Labeling
1985/06/12 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1985/05/13 SUPPL 27 Approval Labeling
1984/10/15 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1984/10/15 SUPPL 24 Approval Labeling
1950/05/11 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
更多信息
药品NDC数据与药品包装、标签说明书
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