药品注册申请号:074569
申请类型:ANDA (仿制药申请)
申请人:TEVA
申请人全名:TEVA 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 CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG No No AB 1996/09/10 1996/09/10 Prescription
002 CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG No No AB 1996/09/10 Prescription
003 CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG No No AB 1996/09/10 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
2016/07/18 SUPPL-41(补充) Approval Labeling STANDARD
2012/07/19 SUPPL-40(补充) Approval REMS
2011/04/08 SUPPL-38(补充) Approval REMS
2011/04/08 SUPPL-37(补充) Approval Labeling
2009/10/15 SUPPL-33(补充) Approval Labeling
2009/10/15 SUPPL-32(补充) Approval Labeling
2009/05/07 SUPPL-31(补充) Approval Labeling
2001/10/16 SUPPL-19(补充) Approval Labeling
2000/10/13 SUPPL-18(补充) Approval Labeling
1999/12/02 SUPPL-17(补充) Approval Manufacturing (CMC)
1999/12/02 SUPPL-16(补充) Approval Manufacturing (CMC)
1999/02/12 SUPPL-10(补充) Approval Manufacturing (CMC)
1999/02/12 SUPPL-9(补充) Approval Manufacturing (CMC)
1998/10/08 SUPPL-8(补充) Approval Manufacturing (CMC)
1998/06/22 SUPPL-7(补充) Approval Labeling
1998/06/22 SUPPL-6(补充) Approval Manufacturing (CMC)
1998/06/22 SUPPL-5(补充) Approval Manufacturing (CMC)
1998/02/18 SUPPL-4(补充) Approval Labeling
1998/01/28 SUPPL-1(补充) Approval Manufacturing (CMC)
1997/11/25 SUPPL-3(补充) Approval Manufacturing (CMC)
1997/07/16 SUPPL-2(补充) Approval Manufacturing (CMC)
1996/09/10 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:CLONAZEPAM 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
017533 001 NDA KLONOPIN CLONAZEPAM TABLET;ORAL 0.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 CHEPLAPHARM
074569 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1996/09/10 TEVA
074869 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1996/10/31 ACTAVIS ELIZABETH
074979 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1997/08/29 SANDOZ
075150 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1998/10/05 AUROBINDO PHARMA USA
075468 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2000/10/06 RUBICON
077147 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2005/05/02 ACCORD HLTHCARE
077856 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2006/06/28 PRINSTON INC
活性成分:CLONAZEPAM 剂型/给药途径:TABLET;ORAL 规格:1MG 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
017533 002 NDA KLONOPIN CLONAZEPAM TABLET;ORAL 1MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 CHEPLAPHARM
074569 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1996/09/10 TEVA
074869 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1996/10/31 ACTAVIS ELIZABETH
074979 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1997/08/29 SANDOZ
075150 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1998/10/05 AUROBINDO PHARMA USA
075468 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 2000/10/06 RUBICON
077147 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 2005/05/02 ACCORD HLTHCARE
077856 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 2006/06/28 PRINSTON INC
活性成分:CLONAZEPAM 剂型/给药途径:TABLET;ORAL 规格:2MG 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
017533 003 NDA KLONOPIN CLONAZEPAM TABLET;ORAL 2MG Prescription Yes No AB Approved Prior to Jan 1, 1982 CHEPLAPHARM
074569 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1996/09/10 TEVA
074869 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1996/10/31 ACTAVIS ELIZABETH
074979 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1997/08/29 SANDOZ
075150 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1998/10/05 AUROBINDO PHARMA USA
075468 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 2000/10/06 RUBICON
077147 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 2005/05/02 ACCORD HLTHCARE
077856 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 2006/06/28 PRINSTON INC
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