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 |
|---|
| 2024/03/27 |
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 |
|---|
| 2025/07/23 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
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:DEXAMETHASONE SODIUM PHOSPHATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 10MG PHOSPHATE/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 |
|---|
| 087702 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
Yes |
AP |
1982/09/07
|
HIKMA |
| 040491 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
Yes |
AP |
2003/04/11
|
FRESENIUS KABI USA |
| 040572 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
Yes |
AP |
2005/04/22
|
FRESENIUS KABI USA |
| 040802 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2008/08/29
|
MYLAN LABS LTD |
| 207442 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2018/04/19
|
SOMERSET THERAPS LLC |
| 209192 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2018/07/06
|
FRESENIUS KABI USA |
| 208690 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2018/08/22
|
AMNEAL |
| 211036 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2019/05/10
|
SOMERSET THERAPS LLC |
| 210967 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2019/06/07
|
EUGIA PHARMA |
| 210966 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2020/06/05
|
EUGIA PHARMA |
| 214890 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Discontinued |
No |
No |
AP |
2023/07/07
|
GENEYORK PHARMS |
| 215654 |
002 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2023/09/25
|
GLAND |
| 217797 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 10MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2024/03/27
|
MICRO LABS |