PERSANTINE-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
003	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AB	1961/12/06	1986/12/22	Discontinued
004	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AB		1987/02/06	Discontinued
005	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	AB		1987/02/06	Discontinued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
1961/12/06	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	STANDARD

>>>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
2019/12/11	SUPPL-61（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
2015/07/29	SUPPL-60（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/05/08	SUPPL-59（补充）	Approval	Manufacturing (CMC)	STANDARD
2005/08/01	SUPPL-57（补充）	Approval	Labeling	STANDARD	Label Letter
2004/08/05	SUPPL-54（补充）	Approval	Labeling	STANDARD	Letter
2002/06/20	SUPPL-56（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
2002/02/08	SUPPL-55（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/05/24	SUPPL-53（补充）	Approval	Manufacturing (CMC)	STANDARD
2000/02/08	SUPPL-52（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/07/03	SUPPL-51（补充）	Approval	Labeling	STANDARD
1995/02/21	SUPPL-46（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/05/18	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD
1994/02/18	SUPPL-49（补充）	Approval	Labeling	STANDARD
1991/03/26	SUPPL-47（补充）	Approval	Labeling
1989/08/30	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD
1988/12/12	SUPPL-42（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/11/08	SUPPL-45（补充）	Approval	Labeling
1988/02/24	SUPPL-41（补充）	Approval	Labeling
1987/02/06	SUPPL-40（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/12/22	SUPPL-38（补充）	Approval	Labeling
1986/12/22	SUPPL-14（补充）	Approval	Efficacy-New Indication
1982/10/08	SUPPL-32（补充）	Approval	Manufacturing (CMC)	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

>>>活性成分:DIPYRIDAMOLE; 剂型/给药途径:TABLET;ORAL; 规格:25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
012836	003	NDA	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AB	1986/12/22	BOEHRINGER INGELHEIM

>>>活性成分:DIPYRIDAMOLE; 剂型/给药途径:TABLET;ORAL; 规格:50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
012836	004	NDA	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AB	1987/02/06	BOEHRINGER INGELHEIM

>>>活性成分:DIPYRIDAMOLE; 剂型/给药途径:TABLET;ORAL; 规格:75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<

申请号	产品号	申请类型	商品名	活性成分	剂型/给药途径	规格	市场状态	RLD	RS	TE Code	产品号批准日期	申请人
012836	005	NDA	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	Yes	No	AB	1987/02/06	BOEHRINGER INGELHEIM