SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE-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
001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	AB	2023/07/31	2023/07/31	Prescription
002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	AB		2023/07/31	Prescription
003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	No	AB		2023/07/31	Prescription

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	通知信、审评文件、说明书、包装标签	备注
2023/07/31	ORIG-1（原始申请）	Approval		STANDARD	Letter

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:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:500MG;EQ 5MG BASE 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
200678	001	NDA	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Discontinued	Yes	No	AB	2010/11/05	ASTRAZENECA AB
205981	001	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Prescription	No	No	AB	2023/07/31	MYLAN
206081	001	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Prescription	No	No	AB	2023/07/31	SUN PHARM
207678	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Prescription	No	No	AB	2023/08/09	DR REDDYS LABS SA

活性成分:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1GM;EQ 2.5MG BASE 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
200678	003	NDA	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Discontinued	Yes	No	AB	2010/11/05	ASTRAZENECA AB
205981	002	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Prescription	No	No	AB	2023/07/31	MYLAN
206081	002	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Prescription	No	No	AB	2023/07/31	SUN PHARM
207678	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Prescription	No	No	AB	2023/08/09	DR REDDYS LABS SA

活性成分:METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1GM;EQ 5MG BASE 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
200678	002	NDA	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Discontinued	Yes	No	AB	2010/11/05	ASTRAZENECA AB
205981	003	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Prescription	No	No	AB	2023/07/31	MYLAN
206081	003	ANDA	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Prescription	No	No	AB	2023/07/31	SUN PHARM
207678	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Prescription	No	Yes	AB	2023/08/09	DR REDDYS LABS SA