药品注册申请号：207384
申请类型：ANDA (仿制药申请)
申请人：GLAND PHARMA LTD
申请人全名：GLAND PHARMA 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 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No AP 2017/09/29 2017/09/29 Prescription
002 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No No AP 2017/09/29 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
2024/02/05 SUPPL-2（补充） Approval Labeling STANDARD
2017/09/29 ORIG-1（原始申请） Approval 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:DEFEROXAMINE MESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/VIAL 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
016267 001 NDA DESFERAL DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 NOVARTIS
076019 001 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2004/03/17 HOSPIRA
078086 001 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2007/05/30 WEST-WARD PHARMS INT
078718 001 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2009/09/15 FRESENIUS KABI USA
207384 001 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2017/09/29 GLAND PHARMA LTD
活性成分:DEFEROXAMINE MESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/VIAL 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
076019 002 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL Prescription No Yes AP 2004/03/17 HOSPIRA
078086 002 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2007/05/30 WEST-WARD PHARMS INT
078718 002 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2009/09/15 FRESENIUS KABI USA
207384 002 ANDA DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2017/09/29 GLAND PHARMA LTD
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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