ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE-美国FDA药品数据库-药物在线

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	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No	AP	2013/07/19	2013/07/19	Prescription

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
2024/07/08	SUPPL-13（补充）	Approval	Labeling	STANDARD
2024/07/08	SUPPL-12（补充）	Approval	Manufacturing (CMC)	STANDARD
2024/07/08	SUPPL-8（补充）	Approval	Labeling	STANDARD
2015/11/16	SUPPL-5（补充）	Approval	Labeling
2015/10/22	SUPPL-7（补充）	Approval	Labeling	STANDARD
2015/10/22	SUPPL-4（补充）	Approval	Labeling	STANDARD
2015/10/09	SUPPL-1（补充）	Approval	Manufacturing (CMC)	UNKNOWN
2013/07/19	ORIG-1（原始申请）	Approval

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

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:ONDANSETRON HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2MG BASE/ML 治疗等效代码:AP

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
076876	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Discontinued	No	No	AP	2006/11/22	TEVA
076967	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HIKMA
076972	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	FRESENIUS KABI USA
076974	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	FRESENIUS KABI USA
077011	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HIKMA
077365	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HIKMA
077473	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HOSPIRA
077541	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HIKMA
077548	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HOSPIRA
077577	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	WOCKHARDT
077716	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	WOCKHARDT
076781	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2006/12/26	HIKMA FARMACEUTICA
077551	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2007/06/27	SANDOZ
077430	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2007/06/27	SANDOZ
079224	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2009/09/25	GLAND PHARMA LTD
090648	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	Yes	AP	2012/06/15	GLAND PHARMA LTD
202599	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Discontinued	No	No	AP	2012/12/21	EUGIA PHARMA
202600	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Discontinued	No	No	AP	2012/12/21	EUGIA PHARMA
078287	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	Yes	AP	2013/02/22	BAXTER HLTHCARE CORP
202253	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2013/07/19	FRESENIUS KABI USA
203711	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	Yes	AP	2014/09/08	QILU PHARM HAINAN
206846	001	ANDA	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Prescription	No	No	AP	2015/07/13	ACCORD HLTHCARE
206845	001	ANDA	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	Discontinued	No	No	AP	2016/03/10	ACCORD HLTHCARE