FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER-美国FDA药品数据库-药物在线

药品注册申请号：076766

申请类型：ANDA (仿制药申请)

申请人：BAXTER HLTHCARE

申请人全名：BAXTER HEALTHCARE CORP

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	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	No	No	AP	2004/07/29	2004/07/29	Prescription
002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	No	No	AP	2004/07/29	2004/07/29	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
2024/07/16	SUPPL-17（补充）	Approval	Labeling	STANDARD
2024/02/16	SUPPL-16（补充）	Approval	Labeling	STANDARD
2023/07/14	SUPPL-14（补充）	Approval	Labeling	STANDARD
2022/08/09	SUPPL-12（补充）	Approval	Labeling	STANDARD
2022/08/09	SUPPL-10（补充）	Approval	Labeling	STANDARD
2015/03/14	SUPPL-8（补充）	Approval	Labeling	STANDARD
2013/06/04	SUPPL-7（补充）	Approval	Labeling	STANDARD
2009/01/14	SUPPL-5（补充）	Approval	Labeling
2004/07/29	ORIG-1（原始申请）	Approval			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:FLUCONAZOLE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/100ML (2MG/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
076087	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	HIKMA
076145	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	FRESENIUS KABI USA
076303	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	HOSPIRA
076766	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	BAXTER HLTHCARE
076736	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2005/08/23	HIKMA FARMACEUTICA
078107	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2008/07/30	WEST-WARD PHARMS INT
079104	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	Yes	AP	2009/07/30	INFORLIFE
077909	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2010/05/26	WOODWARD
077947	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Discontinued	No	No	AP	2010/05/26	BAXTER HLTHCARE CORP
078698	001	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	Prescription	No	No	AP	2012/01/30	HIKMA FARMACEUTICA

活性成分:FLUCONAZOLE 剂型/给药途径:INJECTABLE;INJECTION 规格:400MG/200ML (2MG/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
076087	003	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	HIKMA
076145	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	FRESENIUS KABI USA
076303	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	HOSPIRA
076766	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2004/07/29	BAXTER HLTHCARE
078107	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2008/07/30	WEST-WARD PHARMS INT
079104	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	Yes	AP	2009/07/30	INFORLIFE
077909	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2010/05/26	WOODWARD
077947	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Discontinued	No	No	AP	2010/05/26	BAXTER HLTHCARE CORP
078698	002	ANDA	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	Prescription	No	No	AP	2012/01/30	HIKMA FARMACEUTICA

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