药品注册申请号:084349
申请类型:ANDA (仿制药申请)
申请人:VIATRIS
申请人全名:VIATRIS SPECIALTY LLC
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 Yes Yes None 1976/08/27 Approved Prior to Jan 1, 1982 Prescription
002 DILANTIN PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Yes Yes AB Approved Prior to Jan 1, 1982 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
2022/09/07 SUPPL-88(补充) Approval Labeling STANDARD
2021/10/22 SUPPL-87(补充) Approval Labeling STANDARD
2020/08/07 SUPPL-86(补充) Approval Labeling STANDARD
2018/12/03 SUPPL-85(补充) Approval Labeling STANDARD
2017/12/22 SUPPL-84(补充) Approval Labeling STANDARD
2017/12/22 SUPPL-82(补充) Approval Labeling STANDARD
2017/12/22 SUPPL-81(补充) Approval Labeling STANDARD
2017/02/01 SUPPL-80(补充) Approval Labeling STANDARD
2017/02/01 SUPPL-79(补充) Approval Labeling STANDARD
2017/02/01 SUPPL-78(补充) Approval Labeling STANDARD
2017/02/01 SUPPL-77(补充) Approval Labeling STANDARD
2017/02/01 SUPPL-75(补充) Approval Labeling STANDARD
2015/04/16 SUPPL-74(补充) Approval Labeling STANDARD
2014/07/03 SUPPL-73(补充) Approval Labeling STANDARD
2014/02/27 SUPPL-72(补充) Approval Labeling STANDARD
2014/02/27 SUPPL-62(补充) Approval Labeling
2013/12/26 SUPPL-71(补充) Approval Labeling STANDARD
2013/08/06 SUPPL-70(补充) Approval Labeling STANDARD
2012/11/27 SUPPL-67(补充) Approval Labeling
2011/04/08 SUPPL-64(补充) Approval REMS
2009/07/09 SUPPL-56(补充) Approval Labeling
2009/05/06 SUPPL-60(补充) Approval Labeling
2007/08/08 SUPPL-45(补充) Approval Manufacturing (CMC)
2007/08/08 SUPPL-41(补充) Approval Labeling
2003/12/09 SUPPL-40(补充) Approval Labeling
1998/03/25 SUPPL-38(补充) Approval Manufacturing (CMC)
1998/03/25 SUPPL-37(补充) Approval Manufacturing (CMC)
1997/04/03 SUPPL-34(补充) Approval Manufacturing (CMC)
1997/02/12 SUPPL-31(补充) Approval Manufacturing (CMC)
1997/02/11 SUPPL-33(补充) Approval Manufacturing (CMC)
1996/09/19 SUPPL-35(补充) Approval Manufacturing (CMC)
1993/11/15 SUPPL-30(补充) Approval Manufacturing (CMC)
1990/03/22 SUPPL-26(补充) Approval Bioequivalence
1988/08/25 SUPPL-24(补充) Approval Manufacturing (CMC)
1988/08/25 SUPPL-23(补充) Approval Manufacturing (CMC)
1986/10/15 SUPPL-19(补充) Approval Manufacturing (CMC)
1986/02/11 SUPPL-20(补充) Approval Manufacturing (CMC)
1984/06/14 SUPPL-13(补充) Approval Manufacturing (CMC)
1984/04/09 SUPPL-12(补充) Approval Manufacturing (CMC)
1984/04/09 SUPPL-11(补充) Approval Manufacturing (CMC)
1984/04/09 SUPPL-9(补充) Approval Manufacturing (CMC)
1982/06/02 SUPPL-7(补充) Approval Manufacturing (CMC)
1982/06/02 SUPPL-6(补充) Approval Manufacturing (CMC)
1982/05/27 SUPPL-5(补充) Approval Manufacturing (CMC)
1982/05/18 SUPPL-8(补充) Approval Manufacturing (CMC)
1976/08/27 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: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 Yes Yes AB Approved Prior to Jan 1, 1982 VIATRIS
040298 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Discontinued 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
213834 001 ANDA EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE;ORAL 100MG EXTENDED Discontinued No No AB 2022/10/13 UNICHEM
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