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)
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 | RLD | RS | TE 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 |