DELTASONE-美国FDA药品数据库-药物在线

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
002	DELTASONE	PREDNISONE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1955/06/21	Approved Prior to Jan 1, 1982	Discontinued
005	DELTASONE	PREDNISONE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
006	DELTASONE	PREDNISONE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
007	DELTASONE	PREDNISONE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
008	DELTASONE	PREDNISONE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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

提交状态日期	提交号	审批结论	申请内容分类	审评优先级；罕用药状态
2009/03/13	SUPPL-60（补充）	Approval	Labeling	STANDARD
2009/03/13	SUPPL-59（补充）	Approval	Labeling	STANDARD
2009/03/13	SUPPL-58（补充）	Approval	Labeling	STANDARD
2009/03/13	SUPPL-57（补充）	Approval	Labeling	STANDARD
2009/03/13	SUPPL-54（补充）	Approval	Labeling
2009/03/13	SUPPL-51（补充）	Approval	Labeling
2009/03/13	SUPPL-50（补充）	Approval	Labeling
2009/03/13	SUPPL-47（补充）	Approval	Labeling
2009/03/13	SUPPL-40（补充）	Approval	Labeling
2009/03/13	SUPPL-35（补充）	Approval	Labeling
1993/12/28	SUPPL-55（补充）	Approval	Labeling
1993/05/24	SUPPL-56（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/04/06	SUPPL-52（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/05/20	SUPPL-49（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/01/09	SUPPL-48（补充）	Approval	Labeling
1979/07/23	SUPPL-45（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/04/25	SUPPL-44（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/01/17	SUPPL-43（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/10/18	SUPPL-42（补充）	Approval	Labeling
1977/07/20	SUPPL-41（补充）	Approval	Manufacturing (CMC)	STANDARD
1955/06/21	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	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
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