药品注册申请号：020938
申请类型：NDA (新药申请)
申请人：BOEHRINGER INGELHEIM
申请人全名：BOEHRINGER INGELHEIM PHARMACEUTICALS 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001 MOBIC MELOXICAM TABLET;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2000/04/13 2000/04/13 Discontinued
002 MOBIC MELOXICAM TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2000/08/23 Discontinued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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2000/04/13 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD ;Orphan
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/11/21 SUPPL-30（补充） Approval Labeling-Package Insert STANDARD
2021/04/28 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2016/06/30 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD ;Orphan
2016/05/09 SUPPL-25（补充） Approval Labeling-Package Insert STANDARD ;Orphan
2016/05/09 SUPPL-24（补充） Approval Labeling-Medication Guide,Labeling-Package Insert,Labeling-Package Insert STANDARD ;Orphan
2012/03/05 SUPPL-22（补充） Approval Labeling-Package Insert UNKNOWN
2011/08/03 SUPPL-21（补充） Approval Labeling-Package Insert STANDARD
2010/07/29 SUPPL-20（补充） Approval Labeling-Package Insert UNKNOWN
2010/04/26 SUPPL-19（补充） Approval Labeling STANDARD
2008/06/27 SUPPL-18（补充） Approval Labeling STANDARD
2007/01/25 SUPPL-17（补充） Approval Labeling STANDARD
2005/08/11 SUPPL-15（补充） Approval Labeling STANDARD
2005/08/11 SUPPL-13（补充） Approval Efficacy-New Indication PRIORITY
2004/07/16 SUPPL-4（补充） Approval Efficacy-New Indication STANDARD
2003/04/28 SUPPL-7（补充） Approval Labeling STANDARD
2002/12/13 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
2002/11/21 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/06/10 SUPPL-6（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2002/01/10 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2000/12/15 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/11/14 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2000/08/23 SUPPL-1（补充） Approval Manufacturing (CMC)-Formulation STANDARD ;Orphan
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
001 I-430 2007/07/16**本条是由Drugfuture回溯的历史信息**
I-469 2008/08/11**本条是由Drugfuture回溯的历史信息**
ODE 2012/08/11**本条是由Drugfuture回溯的历史信息**
PED 2008/01/16**本条是由Drugfuture回溯的历史信息**
PED 2009/02/11**本条是由Drugfuture回溯的历史信息**
PED 2013/02/11**本条是由Drugfuture回溯的历史信息**
002 I-430 2007/07/16**本条是由Drugfuture回溯的历史信息**
I-469 2008/08/11**本条是由Drugfuture回溯的历史信息**
ODE 2012/08/11**本条是由Drugfuture回溯的历史信息**
PED 2008/01/16**本条是由Drugfuture回溯的历史信息**
PED 2009/02/11**本条是由Drugfuture回溯的历史信息**
PED 2013/02/11**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:MELOXICAM; 剂型/给药途径:TABLET;ORAL; 规格:7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020938 001 NDA MOBIC MELOXICAM TABLET;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2000/04/13 BOEHRINGER INGELHEIM
>>>活性成分:MELOXICAM; 剂型/给药途径:TABLET;ORAL; 规格:15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020938 002 NDA MOBIC MELOXICAM TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2000/08/23 BOEHRINGER INGELHEIM
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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