药品注册申请号:084903
申请类型:ANDA (仿制药申请)
申请人:LANNETT
申请人全名:LANNETT CO 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 PRIMIDONE PRIMIDONE TABLET;ORAL 250MG No No AB 1978/12/01 Approved Prior to Jan 1, 1982 Prescription
002 PRIMIDONE PRIMIDONE TABLET;ORAL 50MG No No AB 2001/05/24 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
2012/02/01 SUPPL-26(补充) Approval Labeling
2010/05/20 SUPPL-23(补充) Approval Labeling
2002/10/03 SUPPL-20(补充) Approval Manufacturing (CMC)
2001/07/13 SUPPL-19(补充) Approval Labeling
2001/06/25 SUPPL-18(补充) Approval Manufacturing (CMC)
2001/05/24 SUPPL-17(补充) Approval Manufacturing (CMC)
2001/05/24 SUPPL-16(补充) Approval Labeling
2001/05/24 SUPPL-15(补充) Approval Manufacturing (CMC)
2000/08/10 SUPPL-14(补充) Approval Manufacturing (CMC)
2000/08/04 SUPPL-13(补充) Approval Manufacturing (CMC)
1997/12/18 SUPPL-12(补充) Approval Manufacturing (CMC)
1997/03/11 SUPPL-11(补充) Approval Manufacturing (CMC)
1994/11/14 SUPPL-10(补充) Approval Labeling
1993/11/09 SUPPL-9(补充) Approval Manufacturing (CMC)
1993/11/09 SUPPL-8(补充) Approval Manufacturing (CMC)
1993/11/09 SUPPL-7(补充) Approval Manufacturing (CMC)
1993/11/09 SUPPL-6(补充) Approval Labeling
1991/06/28 SUPPL-5(补充) Approval Labeling
1990/03/21 SUPPL-3(补充) Approval Labeling
1978/12/01 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:PRIMIDONE 剂型/给药途径:TABLET;ORAL 规格:250MG 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
009170 002 NDA MYSOLINE PRIMIDONE TABLET;ORAL 250MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALEANT
083551 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
084903 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 LANNETT
040586 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB 2005/02/24 OXFORD PHARMS
040626 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB 2005/09/29 ANDA REPOSITORY
040866 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB 2008/04/23 AMNEAL PHARM
214896 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB 2022/06/28 RUBICON
218366 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 250MG Prescription No No AB 2024/01/23 CARNEGIE
活性成分:PRIMIDONE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
009170 003 NDA MYSOLINE PRIMIDONE TABLET;ORAL 50MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALEANT
084903 002 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2001/05/24 LANNETT
040586 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2005/02/24 OXFORD PHARMS
040626 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2005/09/29 ANDA REPOSITORY
040866 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2008/04/23 AMNEAL PHARM
214896 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2022/06/28 RUBICON
218366 001 ANDA PRIMIDONE PRIMIDONE TABLET;ORAL 50MG Prescription No No AB 2024/01/23 CARNEGIE
更多信息
药品NDC数据与药品包装、标签说明书
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