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TABLET, ORALLY DISINTEGRATING;ORAL 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/12/23 1997/12/23 Discontinued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TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/12/23 Discontinued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TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/12/23 Discontinued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CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/12/23 Discontinued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CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/12/23 Discontinued
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
2016/12/16 SUPPL-10（补充） Approval Labeling STANDARD
2013/10/31 SUPPL-9（补充） Approval Labeling STANDARD
2011/11/29 SUPPL-8（补充） Approval REMS N/A
2010/09/01 SUPPL-7（补充） Approval Labeling STANDARD
2010/09/01 SUPPL-6（补充） Approval Labeling STANDARD
2009/04/23 SUPPL-5（补充） Approval Labeling 901 REQUIRED
2001/12/03 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2001/07/31 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1997/12/23 ORIG-1（原始申请） 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）
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
无
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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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