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 |
|---|
| 2023/10/23 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/10/24 |
ORIG-1（原始申请） |
Approval |
|
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 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:MICAFUNGIN SODIUM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 50MG BASE/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 |
|---|
| 021506 |
002 |
NDA |
MYCAMINE |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
Yes |
Yes |
AP |
2005/03/16
|
ASTELLAS |
| 207344 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/05/17
|
FRESENIUS KABI USA |
| 208366 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2020/11/05
|
APOTEX |
| 211713 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/06/02
|
XELLIA PHARMS APS |
| 213261 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/07/09
|
HIKMA |
| 213363 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/07/09
|
JIANGSU HANSOH PHARM |
| 215381 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/09/28
|
MEITHEAL |
| 215241 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/10/24
|
ZYDUS PHARMS |
| 216438 |
001 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/05/29
|
BIOCON PHARMA |
活性成分:MICAFUNGIN SODIUM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 100MG BASE/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 |
|---|
| 021506 |
003 |
NDA |
MYCAMINE |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
Yes |
Yes |
AP |
2006/06/27
|
ASTELLAS |
| 207344 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/05/17
|
FRESENIUS KABI USA |
| 208366 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2020/11/05
|
APOTEX |
| 211713 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/06/02
|
XELLIA PHARMS APS |
| 213261 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/07/09
|
HIKMA |
| 213363 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/07/09
|
JIANGSU HANSOH PHARM |
| 215381 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/09/28
|
MEITHEAL |
| 215241 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/10/24
|
ZYDUS PHARMS |
| 216438 |
002 |
ANDA |
MICAFUNGIN SODIUM |
MICAFUNGIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/05/29
|
BIOCON PHARMA |