药品注册申请号:040298
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS 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 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED No No AB 1998/12/28 1998/12/28 Prescription
002 PHENYTEK PHENYTOIN SODIUM CAPSULE;ORAL 200MG EXTENDED No No AB 2001/12/06 Prescription
003 PHENYTEK PHENYTOIN SODIUM CAPSULE;ORAL 300MG EXTENDED No Yes AB 2001/12/06 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/12/27 SUPPL 33 Approval Labeling STANDARD
2016/12/27 SUPPL 31 Approval Labeling STANDARD
2014/01/08 SUPPL 30 Approval Labeling STANDARD
2014/01/08 SUPPL 29 Approval Labeling
2014/01/08 SUPPL 28 Approval Labeling
2014/01/08 SUPPL 25 Approval Labeling
2003/04/18 SUPPL 17 Approval Labeling
2002/03/20 SUPPL 15 Approval Manufacturing (CMC)
2002/03/20 SUPPL 14 Approval Manufacturing (CMC)
2002/03/20 SUPPL 13 Approval Labeling
2002/03/20 SUPPL 12 Approval Manufacturing (CMC)
2002/03/20 SUPPL 10 Approval Manufacturing (CMC)
2002/02/19 SUPPL 9 Approval Manufacturing (CMC)
2002/01/17 SUPPL 3 Approval Manufacturing (CMC)
2001/12/06 SUPPL 6 Approval Manufacturing (CMC)
2001/12/06 SUPPL 5 Approval Labeling
2001/12/06 SUPPL 4 Approval Manufacturing (CMC)
2001/03/09 SUPPL 2 Approval Manufacturing (CMC)
1999/09/10 SUPPL 1 Approval Labeling
1998/12/28 ORIG 1 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:PHENYTOIN SODIUM 剂型/给药途径:CAPSULE;ORAL 规格:100MG EXTENDED 治疗等效代码:AB
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
084349 002 ANDA DILANTIN PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No Yes AB Approved Prior to Jan 1, 1982 PARKE-DAVIS
040298 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No No AB 1998/12/28 MYLAN
040684 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No No AB 2006/09/05 TARO
040765 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No No AB 2008/11/12 AMNEAL PHARMS NY
204309 001 ANDA PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No No AB 2015/06/10 AUROBINDO PHARMA LTD
211633 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Prescription No No AB 2019/09/30 LUPIN LTD
活性成分:PHENYTOIN SODIUM 剂型/给药途径:CAPSULE;ORAL 规格:200MG EXTENDED 治疗等效代码:AB
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
040298 002 ANDA PHENYTEK PHENYTOIN SODIUM CAPSULE;ORAL 200MG EXTENDED Prescription No No AB 2001/12/06 MYLAN
040731 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 200MG EXTENDED Prescription No No AB 2008/06/30 SUN PHARM INDS
活性成分:PHENYTOIN SODIUM 剂型/给药途径:CAPSULE;ORAL 规格:300MG EXTENDED 治疗等效代码:AB
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
040298 003 ANDA PHENYTEK PHENYTOIN SODIUM CAPSULE;ORAL 300MG EXTENDED Prescription No Yes AB 2001/12/06 MYLAN
040731 002 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 300MG EXTENDED Prescription No No AB 2008/06/30 SUN PHARM INDS
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