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 |
|---|
| 2021/04/01 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/28 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/30 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
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 |
|---|
| 001 |
9636407 |
2032/12/21 |
|
Y |
|
|
2017/05/10
|
PDF格式 | |
| 002 |
9636407 |
2032/12/21 |
|
Y |
|
|
2017/05/10
|
PDF格式 | |
与本品治疗等效的药品
活性成分:CASPOFUNGIN ACETATE 剂型/给药途径:POWDER;INTRAVENOUS 规格:50MG/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 |
|---|
| 021227 |
001 |
NDA |
CANCIDAS |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2001/01/26
|
MERCK |
| 206110 |
001 |
NDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2016/12/30
|
FRESENIUS KABI USA |
| 207092 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/29
|
GLAND |
| 200833 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2018/06/28
|
HENGRUI PHARMA |
| 205923 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Discontinued |
No |
No |
AP |
2018/07/02
|
XELLIA PHARMS APS |
| 211263 |
001 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/01
|
AREVA PHARMS |
活性成分:CASPOFUNGIN ACETATE 剂型/给药途径:POWDER;INTRAVENOUS 规格:70MG/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 |
|---|
| 021227 |
002 |
NDA |
CANCIDAS |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2001/01/26
|
MERCK |
| 206110 |
002 |
NDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2016/12/30
|
FRESENIUS KABI USA |
| 207092 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/29
|
GLAND |
| 200833 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2018/06/28
|
HENGRUI PHARMA |
| 205923 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Discontinued |
No |
No |
AP |
2018/07/02
|
XELLIA PHARMS APS |
| 211263 |
002 |
ANDA |
CASPOFUNGIN ACETATE |
CASPOFUNGIN ACETATE |
POWDER;INTRAVENOUS |
70MG/VIAL |
Prescription |
No |
No |
AP |
2021/10/01
|
AREVA PHARMS |