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 |
|---|
| 1965/03/03 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
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 |
|---|
| 2024/07/08 |
SUPPL-64（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/06/05 |
SUPPL-68（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2022/09/06 |
SUPPL-65（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2018/04/10 |
SUPPL-62（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/02/09 |
SUPPL-61（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/02/04 |
SUPPL-59（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2014/07/03 |
SUPPL-58（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2014/05/21 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/03/13 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/01/09 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2008/06/24 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/07/12 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/07/24 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2000/04/10 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/10/08 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/07/15 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1997/07/21 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1996/11/13 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/05/03 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1994/04/13 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/03/14 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1993/09/07 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1992/12/17 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1992/02/06 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/05/01 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/01 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1986/06/10 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/11/04 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/06/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/08 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
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:BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:3MG/ML;EQ 3MG BASE/ML; 治疗等效代码:AB<<<
| 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 |
|---|
| 014602 |
001 |
NDA |
CELESTONE SOLUSPAN |
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
3MG/ML;EQ 3MG BASE/ML |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
ORGANON |
| 090747 |
001 |
ANDA |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE |
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
3MG/ML;EQ 3MG BASE/ML |
Prescription |
No |
No |
AB |
2009/07/31
|
AM REGENT |
| 077838 |
001 |
ANDA |
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE |
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE |
INJECTABLE;INJECTION |
3MG/ML;EQ 3MG BASE/ML |
Prescription |
No |
No |
AB |
2023/01/17
|
HIKMA |
