药品注册申请号:077481
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA INC
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 FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML No No AP 2007/08/06 2007/08/06 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
2007/08/06 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
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
与本品治疗等效的药品
活性成分:FOSPHENYTOIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG PHENYTOIN NA/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
020450 001 NDA CEREBYX FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription Yes Yes AP 1996/08/05 PARKE DAVIS
077481 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2007/08/06 HIKMA
077989 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2007/08/06 HIKMA
078052 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2007/08/06 FRESENIUS KABI USA
078137 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2007/08/06 WOCKHARDT
078417 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2008/03/18 SUN PHARM
078765 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2009/12/02 HIKMA FARMACEUTICA
078736 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Discontinued No No AP 2010/06/08 MYLAN LABS LTD
214926 001 ANDA FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM INJECTABLE;INJECTION EQ 50MG PHENYTOIN NA/ML Prescription No No AP 2023/10/13 GLAND PHARMA LTD
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