药品注册申请号：004056
申请类型：NDA (新药申请)
申请人：BRISTOL MYERS SQUIBB
申请人全名：BRISTOL MYERS SQUIBB
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 STILBESTROL DIETHYLSTILBESTROL SUPPOSITORY;VAGINAL 0.1MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
002 STILBESTROL DIETHYLSTILBESTROL SUPPOSITORY;VAGINAL 0.5MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
003 STILBESTROL DIETHYLSTILBESTROL INJECTABLE;INJECTION 0.2MG/ML No No None --- Approved Prior to Jan 1, 1982 Discontinued
004 STILBESTROL DIETHYLSTILBESTROL INJECTABLE;INJECTION 0.5MG/ML No No None --- Approved Prior to Jan 1, 1982 Discontinued
005 STILBESTROL DIETHYLSTILBESTROL INJECTABLE;INJECTION 1MG/ML No No None --- Approved Prior to Jan 1, 1982 Discontinued
006 STILBESTROL DIETHYLSTILBESTROL INJECTABLE;INJECTION 5MG/ML No No None --- Approved Prior to Jan 1, 1982 Discontinued
007 STILBETIN DIETHYLSTILBESTROL TABLET;ORAL 0.1MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
008 STILBETIN DIETHYLSTILBESTROL TABLET;ORAL 0.5MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
009 STILBETIN DIETHYLSTILBESTROL TABLET;ORAL 1MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
010 STILBETIN DIETHYLSTILBESTROL TABLET;ORAL 5MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
011 STILBETIN DIETHYLSTILBESTROL TABLET, DELAYED RELEASE;ORAL 0.1MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
012 STILBETIN DIETHYLSTILBESTROL TABLET, DELAYED RELEASE;ORAL 0.5MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
013 STILBETIN DIETHYLSTILBESTROL TABLET, DELAYED RELEASE;ORAL 1MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
014 STILBETIN DIETHYLSTILBESTROL TABLET, DELAYED RELEASE;ORAL 5MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
017 STILBETIN DIETHYLSTILBESTROL TABLET;ORAL 0.25MG No No None --- Approved Prior to Jan 1, 1982 Discontinued
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
无
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
无
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
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database