药品注册申请号:020415
申请类型:NDA (新药申请)
申请人:ORGANON
申请人全名:ORGANON USA LLC
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 MIRTAZAPINE TABLET;ORAL 15MG Yes Yes AB 1996/06/14 1996/06/14 Prescription
002 REMERON MIRTAZAPINE TABLET;ORAL 30MG Yes No AB 1996/06/14 Prescription
003 REMERON MIRTAZAPINE TABLET;ORAL 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/03/17 Discontinued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
2021/11/18 SUPPL-38(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-36(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-34(补充) Approval Labeling STANDARD
2020/03/04 SUPPL-29(补充) Approval Labeling STANDARD
2019/09/05 SUPPL-35(补充) Approval Labeling STANDARD
2016/07/08 SUPPL-30(补充) Approval Labeling STANDARD
2015/12/30 SUPPL-32(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2014/07/18 SUPPL-31(补充) Approval Labeling 901 REQUIRED
2012/12/11 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
2012/10/30 SUPPL-26(补充) Approval Labeling STANDARD
2011/12/27 SUPPL-22(补充) Approval Labeling STANDARD
2010/05/14 SUPPL-24(补充) Approval Labeling UNKNOWN
2010/05/14 SUPPL-23(补充) Approval Labeling UNKNOWN
2007/07/30 SUPPL-19(补充) Approval Labeling STANDARD
2005/01/12 SUPPL-18(补充) Approval Labeling STANDARD
2004/06/01 SUPPL-16(补充) Approval Labeling STANDARD
2002/09/30 SUPPL-15(补充) Approval Labeling STANDARD
2002/04/09 SUPPL-9(补充) Approval Efficacy STANDARD
2001/11/20 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2001/01/26 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2000/08/30 SUPPL-6(补充) Approval Labeling STANDARD
2000/07/19 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2000/02/28 SUPPL-7(补充) Approval Labeling STANDARD
1999/05/11 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1998/04/09 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1997/03/17 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1996/11/07 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1996/11/04 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1996/06/14 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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
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;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
020415 001 NDA REMERON MIRTAZAPINE TABLET;ORAL 15MG Prescription Yes Yes AB 1996/06/14 ORGANON
076119 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2003/01/24 TEVA
076122 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2003/06/19 MYLAN
076219 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2003/06/19 CHARTWELL RX
076541 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2004/04/22 SUN PHARM INDS INC
076921 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2004/10/22 AUROBINDO
077666 001 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2007/08/22 APOTEX INC
216751 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 15MG Prescription No No AB 2023/01/18 PRASCO
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET;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
020415 002 NDA REMERON MIRTAZAPINE TABLET;ORAL 30MG Prescription Yes No AB 1996/06/14 ORGANON
076119 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2003/01/24 TEVA
076122 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2003/06/19 MYLAN
076219 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2003/06/19 CHARTWELL RX
076541 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2004/04/22 SUN PHARM INDS INC
076921 003 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2004/10/22 AUROBINDO
077666 002 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2007/08/22 APOTEX INC
216751 003 ANDA MIRTAZAPINE MIRTAZAPINE TABLET;ORAL 30MG Prescription No No AB 2023/01/18 PRASCO
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