药品注册申请号:020829
申请类型:NDA (新药申请)
申请人:ORGANON
申请人全名:ORGANON 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
002 SINGULAIR MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Yes Yes AB 1998/02/20 1998/02/20 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
2021/02/22 SUPPL-74(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-73(补充) Approval Labeling STANDARD
2019/08/09 SUPPL-72(补充) Approval Labeling STANDARD
2018/12/21 SUPPL-71(补充) Approval Labeling STANDARD
2018/12/21 SUPPL-70(补充) Approval Labeling STANDARD
2016/12/13 SUPPL-69(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-68(补充) Approval Labeling STANDARD
2014/01/28 SUPPL-67(补充) Approval Manufacturing (CMC) STANDARD
2013/12/30 SUPPL-66(补充) Approval Labeling STANDARD
2013/03/21 SUPPL-65(补充) Approval Labeling STANDARD
2012/10/18 SUPPL-61(补充) Approval Labeling UNKNOWN
2012/09/27 SUPPL-63(补充) Approval Labeling UNKNOWN
2012/07/16 SUPPL-62(补充) Approval Labeling UNKNOWN
2012/03/26 SUPPL-59(补充) Approval Efficacy STANDARD
2011/12/16 SUPPL-60(补充) Approval Labeling UNKNOWN
2011/06/10 SUPPL-54(补充) Approval Labeling UNKNOWN
2011/04/27 SUPPL-57(补充) Approval Labeling UNKNOWN
2010/08/10 SUPPL-55(补充) Approval Labeling UNKNOWN
2010/04/26 SUPPL-52(补充) Approval Labeling STANDARD
2009/08/19 SUPPL-51(补充) Approval Labeling STANDARD
2009/01/27 SUPPL-49(补充) Approval Labeling STANDARD
2008/04/24 SUPPL-48(补充) Approval Labeling STANDARD
2008/04/21 SUPPL-47(补充) Approval Labeling STANDARD
2008/03/07 SUPPL-46(补充) Approval Labeling STANDARD
2007/04/13 SUPPL-43(补充) Approval Labeling STANDARD
2007/04/13 SUPPL-42(补充) Approval Labeling STANDARD
2007/04/13 SUPPL-41(补充) Approval Labeling STANDARD
2007/04/13 SUPPL-36(补充) Approval Efficacy UNKNOWN
2006/12/08 SUPPL-39(补充) Approval Labeling STANDARD
2006/05/19 SUPPL-38(补充) Approval Labeling STANDARD
2005/11/30 SUPPL-34(补充) Approval Efficacy UNKNOWN
2005/07/27 SUPPL-33(补充) Approval Efficacy UNKNOWN
2005/06/27 SUPPL-37(补充) Approval Labeling STANDARD
2005/05/26 SUPPL-35(补充) Approval Labeling STANDARD
2004/12/29 SUPPL-32(补充) Approval Labeling STANDARD
2004/11/15 SUPPL-31(补充) Approval Labeling STANDARD
2004/11/15 SUPPL-29(补充) Approval Labeling STANDARD
2003/12/19 SUPPL-26(补充) Approval Labeling STANDARD
2003/11/05 SUPPL-25(补充) Approval Labeling STANDARD
2003/10/02 SUPPL-23(补充) Approval Labeling STANDARD
2002/12/31 SUPPL-17(补充) Approval Efficacy STANDARD
2002/10/07 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2002/07/11 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2002/02/11 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2001/10/26 SUPPL-14(补充) Approval Labeling STANDARD
2001/08/02 SUPPL-12(补充) Approval Labeling STANDARD
2001/06/18 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2000/10/17 SUPPL-9(补充) Approval Labeling STANDARD
2000/09/05 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1999/07/28 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1999/02/12 SUPPL-1(补充) Approval Labeling STANDARD
1999/01/21 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1998/12/01 SUPPL-6(补充) Approval Labeling STANDARD
1998/09/18 SUPPL-4(补充) Approval Labeling STANDARD
1998/04/30 SUPPL-3(补充) Approval Labeling STANDARD
1998/04/02 SUPPL-2(补充) Approval Labeling STANDARD
1998/02/20 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
002 5565473 2012/02/03 Y Y U-228 U-675 U-807 PDF格式**本条是由Drugfuture回溯的历史信息**
5565473*PED 2012/08/03 U-228 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
002 I-465 2008/08/27**本条是由Drugfuture回溯的历史信息**
I-530 2010/04/13**本条是由Drugfuture回溯的历史信息**
M-49 2008/11/30**本条是由Drugfuture回溯的历史信息**
NPP 2015/03/26**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:MONTELUKAST SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 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
020829 002 NDA SINGULAIR MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 1998/02/20 ORGANON
078605 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/03 TEVA PHARMS
090926 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/03 GLENMARK PHARMS LTD
200889 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2012/08/03 SANDOZ INC
201515 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/03 TORRENT PHARMS LTD
201522 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/03 CHARTWELL MOLECULAR
202468 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/03 AUROBINDO PHARMA LTD
201582 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/08/06 DR REDDYS LABS LTD
202717 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2012/09/21 ACCORD HLTHCARE
202843 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/09/10 HETERO LABS LTD V
203366 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/09/11 MACLEODS PHARMS LTD
202859 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/10/30 UNIMARK REMEDIES LTD
204604 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/09/04 AMNEAL PHARMS
204290 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/10/08 UNICHEM
205683 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/01/12 ANBISON LAB
207463 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/28 CIPLA
209012 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/04/24 RISING
206112 001 ANDA MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2017/04/26 L PERRIGO CO
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