药品注册申请号：078107
申请类型：ANDA (仿制药申请)
申请人：WEST-WARD PHARMS INT
申请人全名：WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
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 2008/07/30 2008/07/30 Prescription
002 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE INJECTABLE;INJECTION 400MG/200ML (2MG/ML) No No AP 2008/07/30 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
2020/12/07 SUPPL-5（补充） Approval Labeling STANDARD
2020/12/07 SUPPL-4（补充） Approval Labeling STANDARD
2012/03/28 SUPPL-3（补充） Approval Labeling
2012/03/20 SUPPL-2（补充） Approval Labeling
2008/07/30 ORIG-1（原始申请） Approval
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RLDRSTE 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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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