药品注册申请号：075825
申请类型：ANDA (仿制药申请)
申请人：SAGENT
申请人全名：SAGENT PHARMACEUTICALS
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 FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML No No AP 2001/04/17 2001/04/17 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
2001/04/17 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:FAMOTIDINE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/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
075486 001 ANDA FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No Yes AP 2001/04/16 HIKMA
075488 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No Yes AP 2001/04/16 HIKMA
075622 001 ANDA FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/16 SAGENT
075651 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/16 SAGENT
075684 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/16 SAGENT
075709 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/16 FRESENIUS KABI USA
075813 001 ANDA FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/16 FRESENIUS KABI USA
075825 001 ANDA FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2001/04/17 SAGENT
078641 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2008/06/25 MYLAN LABS LTD
078642 001 ANDA FAMOTIDINE PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2008/06/25 MYLAN LABS LTD
215828 001 ANDA FAMOTIDINE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML Discontinued No No AP 2022/11/22 ZYDUS PHARMS
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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