药品注册申请号:019753
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
001 ETHMOZINE MORICIZINE HYDROCHLORIDE TABLET;ORAL 200MG No No None 1990/06/19 1990/06/19 Discontinued
002 ETHMOZINE MORICIZINE HYDROCHLORIDE TABLET;ORAL 250MG No No None 1990/06/19 Discontinued
003 ETHMOZINE MORICIZINE HYDROCHLORIDE TABLET;ORAL 300MG No No None 1990/06/19 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
1997/05/27 SUPPL 8 Approval Labeling STANDARD
1996/10/11 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1992/09/16 SUPPL 5 Approval Labeling
1992/07/08 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1992/06/22 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1991/09/20 SUPPL 3 Approval Labeling
1990/08/23 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1990/06/19 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
©2006-2019 DrugFuture->U.S. FDA Drugs Database