药品注册申请号:020813
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 RAPIDLY DISINTEGRATING CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/23 1997/12/23 Discontinued
002 KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/23 Discontinued
003 KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/23 Discontinued
004 KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/23 Discontinued
005 KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/12/23 Discontinued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
2016/12/16 SUPPL 10 Approval Labeling STANDARD
2013/10/31 SUPPL 9 Approval Labeling STANDARD
2011/11/29 SUPPL 8 Approval REMS N/A
2010/09/01 SUPPL 7 Approval Labeling STANDARD
2010/09/01 SUPPL 6 Approval Labeling STANDARD
2009/04/23 SUPPL 5 Approval Labeling 901 REQUIRED
2001/12/03 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/07/31 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/12/23 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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