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 |
2021/07/30 |
SUPPL-17(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2021/03/24 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/11/27 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/07/27 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/10/15 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2013/09/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/13 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/09/30 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/06/16 |
SUPPL-4(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2011/04/12 |
SUPPL-1(补充) |
Approval |
Labeling |
UNKNOWN
;Orphan
|
|
|
2009/11/05 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
;Orphan
|
|
|
与本品治疗等效的药品
活性成分:ROMIDEPSIN 剂型/给药途径:POWDER;INTRAVENOUS 规格:10MG/VIAL 治疗等效代码:AP
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 |
022393 |
001 |
NDA |
ISTODAX |
ROMIDEPSIN |
POWDER;INTRAVENOUS |
10MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2009/11/05
|
BRISTOL-MYERS |
206254 |
001 |
ANDA |
ROMIDEPSIN |
ROMIDEPSIN |
POWDER;INTRAVENOUS |
10MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/12
|
FRESENIUS KABI USA |