药品注册申请号:017533
申请类型:NDA (新药申请)
申请人:ROCHE
申请人全名:HOFFMANN LA ROCHE 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 KLONOPIN CLONAZEPAM TABLET;ORAL 0.5MG Yes No AB 1975/06/04 Approved Prior to Jan 1, 1982 Prescription
002 KLONOPIN CLONAZEPAM TABLET;ORAL 1MG Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
003 KLONOPIN CLONAZEPAM TABLET;ORAL 2MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
005 KLONOPIN CLONAZEPAM TABLET;ORAL 0.125MG No No None 1997/04/09 Discontinued
006 KLONOPIN CLONAZEPAM TABLET;ORAL 0.25MG No No None 1997/04/09 Discontinued
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
2017/10/25 SUPPL 59 Approval Labeling STANDARD
2016/12/16 SUPPL 58 Approval Labeling STANDARD
2016/11/02 SUPPL 57 Approval Manufacturing (CMC) STANDARD
2016/06/13 SUPPL 56 Approval Manufacturing (CMC) PRIORITY
2016/03/25 SUPPL 55 Approval Labeling STANDARD
2015/02/03 SUPPL 54 Approval Manufacturing (CMC) PRIORITY
2013/10/31 SUPPL 53 Approval Labeling STANDARD
2011/11/29 SUPPL 52 Approval REMS N/A
2010/09/01 SUPPL 48 Approval Labeling UNKNOWN
2010/09/01 SUPPL 46 Approval Labeling STANDARD
2009/04/23 SUPPL 45 Approval Labeling 901 REQUIRED
2002/03/15 SUPPL 39 Approval Manufacturing (CMC) PRIORITY
2002/03/11 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
2002/01/29 SUPPL 37 Approval Labeling STANDARD
2001/11/07 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
2001/09/10 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
2001/04/11 SUPPL 31 Approval Labeling STANDARD
2001/01/22 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
2000/03/28 SUPPL 33 Approval Manufacturing (CMC) PRIORITY
1999/10/18 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1997/12/30 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1997/09/19 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1997/04/09 SUPPL 23 Approval Efficacy STANDARD
1997/03/07 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1996/11/20 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1996/10/17 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1996/08/30 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1996/06/18 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1994/07/01 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1993/06/03 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1993/06/03 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1993/05/28 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1993/04/30 SUPPL 19 Approval Labeling
1993/04/30 SUPPL 17 Approval Labeling
1990/07/19 SUPPL 16 Approval Labeling
1990/07/19 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1987/05/01 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1985/12/13 SUPPL 13 Approval Labeling
1984/12/11 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1983/12/19 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1981/02/24 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1981/01/13 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1980/06/13 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1979/09/19 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1979/03/23 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1978/08/30 SUPPL 3 Approval Labeling
1975/09/26 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1975/06/30 SUPPL 2 Approval Labeling
1975/06/04 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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 ROCHE
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
074964 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1997/12/30 WATSON LABS
075150 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1998/10/05 MYLAN
075423 001 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2001/04/27 SUN PHARM INDS INC
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 ROCHE
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
074964 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1997/12/30 WATSON LABS
075150 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 1998/10/05 MYLAN
075423 002 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG Prescription No No AB 2001/04/27 SUN PHARM INDS INC
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 ROCHE
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
074964 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1997/12/30 WATSON LABS
075150 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 1998/10/05 MYLAN
075423 003 ANDA CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG Prescription No No AB 2001/04/27 SUN PHARM INDS INC
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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