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 |
2022/08/22 |
SUPPL-70(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/08/22 |
SUPPL-69(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/01/02 |
SUPPL-67(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/07/15 |
SUPPL-64(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/06/18 |
SUPPL-66(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/05 |
SUPPL-65(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/05/23 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/01/12 |
SUPPL-62(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/04/11 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/05 |
SUPPL-58(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/07/31 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/05/28 |
SUPPL-55(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2015/03/06 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/30 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/07 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/12/10 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/07/11 |
SUPPL-49(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/06/06 |
SUPPL-50(补充) |
Approval |
REMS |
N/A
|
|
|
2010/11/23 |
SUPPL-47(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2010/11/23 |
SUPPL-44(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/11/08 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/07/02 |
SUPPL-46(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/22 |
SUPPL-43(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/22 |
SUPPL-42(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/01/25 |
SUPPL-45(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/10/08 |
SUPPL-41(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2009/09/24 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/01/29 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/03/05 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/03/05 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/14 |
SUPPL-33(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2007/10/17 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/02 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/30 |
SUPPL-29(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2007/01/12 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/09 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/10/19 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/06/02 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/06/02 |
SUPPL-24(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2005/10/07 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/10/07 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/06/30 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/06/30 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/03/11 |
SUPPL-19(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2004/07/20 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/10/02 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/04/11 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2003/03/19 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/31 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/23 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/23 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/23 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/23 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/23 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/08/25 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/05/03 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/03/17 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
;Orphan
|
|
|
1999/09/15 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
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:SIROLIMUS 剂型/给药途径:SOLUTION;ORAL 规格:1MG/ML 治疗等效代码:AA
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 |
021083 |
001 |
NDA |
RAPAMUNE |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
Yes |
Yes |
AA |
1999/09/15
|
PF PRISM CV |
211040 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2019/01/28
|
NOVITIUM PHARMA |
211212 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2019/10/18
|
AMNEAL |
211406 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2019/10/22
|
APOTEX |
215016 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Discontinued |
No |
No |
AA |
2021/12/27
|
TORRENT |
216728 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2023/01/19
|
MSN |
215080 |
001 |
ANDA |
SIROLIMUS |
SIROLIMUS |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2024/09/16
|
HETERO LABS LTD V |