药品注册申请号:021208
申请类型:NDA (新药申请)
申请人:ORGANON USA ORGANON
申请人全名:ORGANON USA LLC A SUB OF ORGANON AND CO
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 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes Yes AB 2001/01/12 2001/01/12 Prescription
002 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Yes No AB 2001/01/12 Prescription
003 REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Yes No AB 2001/01/12 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
2021/11/18 SUPPL-28(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-26(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-24(补充) Approval Labeling STANDARD
2020/03/04 SUPPL-19(补充) Approval Labeling STANDARD
2019/09/05 SUPPL-25(补充) Approval Labeling STANDARD
2016/07/08 SUPPL-20(补充) Approval Labeling STANDARD
2015/12/30 SUPPL-22(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2014/07/18 SUPPL-21(补充) Approval Labeling 901 REQUIRED
2012/10/30 SUPPL-16(补充) Approval Labeling STANDARD
2011/12/23 SUPPL-12(补充) Approval Labeling STANDARD
2010/05/14 SUPPL-14(补充) Approval Labeling UNKNOWN
2010/05/14 SUPPL-13(补充) Approval Labeling UNKNOWN
2007/07/30 SUPPL-10(补充) Approval Labeling STANDARD
2005/01/12 SUPPL-9(补充) Approval Labeling STANDARD
2004/06/01 SUPPL-8(补充) Approval Labeling STANDARD
2002/11/14 SUPPL-6(补充) Approval Labeling STANDARD
2002/05/21 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2002/04/03 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
2001/11/20 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2001/03/23 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2001/02/22 SUPPL-1(补充) Approval Labeling STANDARD
2001/01/12 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
001 5178878 2010/01/12 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5178878 2010/01/12 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5178878 2010/01/12 PDF格式**本条是由Drugfuture回溯的历史信息**
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:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:15MG 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
021208 001 NDA REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription Yes Yes AB 2001/01/12 ORGANON USA ORGANON
077376 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2005/12/08 AUROBINDO PHARMA
205798 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2017/06/01 SQUARE PHARMS
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:30MG 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
021208 002 NDA REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Prescription Yes No AB 2001/01/12 ORGANON USA ORGANON
077376 003 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Prescription No No AB 2005/12/08 AUROBINDO PHARMA
205798 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Prescription No No AB 2017/06/01 SQUARE PHARMS
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:45MG 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
021208 003 NDA REMERON SOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Prescription Yes No AB 2001/01/12 ORGANON USA ORGANON
077376 004 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Prescription No No AB 2006/02/28 AUROBINDO PHARMA
205798 003 ANDA MIRTAZAPINE MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Prescription No No AB 2017/06/01 SQUARE PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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