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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2023/08/14 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/10/22 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
UNKNOWN
|
|
|
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 |
|---|
| 无 |
与本品治疗等效的药品
>>>活性成分:ICATIBANT ACETATE; 剂型/给药途径:INJECTABLE;SUBCUTANEOUS; 规格:EQ 30MG BASE/3ML (EQ 10MG BASE/ML); 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 |
|---|
| 022150 |
001 |
NDA |
FIRAZYR |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2011/08/25
|
TAKEDA PHARMS USA |
| 210118 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2019/07/15
|
TEVA PHARMS USA |
| 211021 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/03/09
|
JIANGSU HANSOH PHARM |
| 208317 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/06/18
|
FRESENIUS KABI USA |
| 212446 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/07/13
|
CIPLA |
| 211501 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/09/01
|
WILSHIRE PHARMS INC |
| 212081 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/12/16
|
NANG KUANG PHARM CO |
| 213222 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Discontinued |
No |
No |
AP |
2021/05/21
|
GLENMARK PHARMS LTD |
| 213521 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2023/08/14
|
EUGIA PHARMA |
| 213773 |
001 |
ANDA |
ICATIBANT ACETATE |
ICATIBANT ACETATE |
INJECTABLE;SUBCUTANEOUS |
EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/06/14
|
ALEMBIC |