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 |
|---|
| 2024/06/05 |
SUPPL-75（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/07/28 |
SUPPL-69（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/07/28 |
SUPPL-65（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/07/03 |
SUPPL-66（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/12/05 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/06/13 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/07/20 |
SUPPL-54（补充） |
Approval |
Labeling |
|
|
|
| 1994/01/11 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1991/09/13 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/06/13 |
SUPPL-52（补充） |
Approval |
Labeling |
|
|
|
| 1991/02/06 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1989/07/12 |
SUPPL-48（补充） |
Approval |
Labeling |
|
|
|
| 1988/11/02 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 1986/06/13 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/03 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/03 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/12/06 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/01/17 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/12/06 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/04/19 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1977/09/06 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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 4MG 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 |
|---|
| 084282 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 084916 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 040803 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2008/08/29
|
MYLAN LABS LTD |
| 203129 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2015/09/30
|
FRESENIUS KABI USA |
| 206781 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2015/12/01
|
EUGIA PHARMA |
| 207521 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2018/06/08
|
SOMERSET |
| 208689 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2018/08/22
|
AMNEAL |
| 215654 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Prescription |
No |
No |
AP |
2021/08/04
|
GLAND PHARMA LTD |
| 211451 |
001 |
ANDA |
DEXAMETHASONE SODIUM PHOSPHATE |
DEXAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
EQ 4MG PHOSPHATE/ML |
Discontinued |
No |
No |
AP |
2023/08/01
|
HIKMA |
