药品注册申请号:084349
申请类型:ANDA (仿制药申请)
申请人:PARKE-DAVIS
申请人全名:PARKE-DAVIS DIVISION OF PFIZER 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 DILANTIN PHENYTOIN SODIUM CAPSULE;ORAL 30MG EXTENDED No Yes None 1976/08/27 Approved Prior to Jan 1, 1982 Prescription
002 DILANTIN PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED No Yes AB Approved Prior to Jan 1, 1982 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
2018/12/03 SUPPL 85 Approval Labeling STANDARD
2017/12/22 SUPPL 84 Approval Labeling STANDARD
2017/12/22 SUPPL 82 Approval Labeling STANDARD
2017/12/22 SUPPL 81 Approval Labeling STANDARD
2017/02/01 SUPPL 80 Approval Labeling STANDARD
2017/02/01 SUPPL 79 Approval Labeling STANDARD
2017/02/01 SUPPL 78 Approval Labeling STANDARD
2017/02/01 SUPPL 77 Approval Labeling STANDARD
2017/02/01 SUPPL 75 Approval Labeling STANDARD
2015/04/16 SUPPL 74 Approval Labeling STANDARD
2014/07/03 SUPPL 73 Approval Labeling STANDARD
2014/02/27 SUPPL 72 Approval Labeling STANDARD
2014/02/27 SUPPL 62 Approval Labeling
2013/12/26 SUPPL 71 Approval Labeling STANDARD
2013/08/06 SUPPL 70 Approval Labeling STANDARD
2012/11/27 SUPPL 67 Approval Labeling
2011/04/08 SUPPL 64 Approval REMS
2009/07/09 SUPPL 56 Approval Labeling
2009/05/06 SUPPL 60 Approval Labeling
2007/08/08 SUPPL 45 Approval Manufacturing (CMC)
2007/08/08 SUPPL 41 Approval Labeling
2003/12/09 SUPPL 40 Approval Labeling
1998/03/25 SUPPL 38 Approval Manufacturing (CMC)
1998/03/25 SUPPL 37 Approval Manufacturing (CMC)
1997/04/03 SUPPL 34 Approval Manufacturing (CMC)
1997/02/12 SUPPL 31 Approval Manufacturing (CMC)
1997/02/11 SUPPL 33 Approval Manufacturing (CMC)
1996/09/19 SUPPL 35 Approval Manufacturing (CMC)
1993/11/15 SUPPL 30 Approval Manufacturing (CMC)
1990/03/22 SUPPL 26 Approval Bioequivalence
1988/08/25 SUPPL 24 Approval Manufacturing (CMC)
1988/08/25 SUPPL 23 Approval Manufacturing (CMC)
1986/10/15 SUPPL 19 Approval Manufacturing (CMC)
1986/02/11 SUPPL 20 Approval Manufacturing (CMC)
1984/06/14 SUPPL 13 Approval Manufacturing (CMC)
1984/04/09 SUPPL 12 Approval Manufacturing (CMC)
1984/04/09 SUPPL 11 Approval Manufacturing (CMC)
1984/04/09 SUPPL 9 Approval Manufacturing (CMC)
1982/06/02 SUPPL 7 Approval Manufacturing (CMC)
1982/06/02 SUPPL 6 Approval Manufacturing (CMC)
1982/05/27 SUPPL 5 Approval Manufacturing (CMC)
1982/05/18 SUPPL 8 Approval Manufacturing (CMC)
1976/08/27 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
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