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 |
|---|
| 2022/05/09 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/09/01 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2002/07/31 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/07/31 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/12/04 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/10/03 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/02 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/11/30 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/09/19 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/05/16 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/01/19 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/01/29 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/01/29 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1997/03/07 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/08/10 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/05/23 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/03/09 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/07/07 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/04/04 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/09/22 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/02 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/01/08 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/10/24 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/09/15 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1981/01/27 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1979/05/31 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1946/04/12 |
ORIG-1（原始申请） |
Approval |
|
UNKNOWN
|
|
|
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:DIHYDROERGOTAMINE MESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AP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 |
|---|
| 005929 |
001 |
NDA |
D.H.E. 45 |
DIHYDROERGOTAMINE MESYLATE |
INJECTABLE;INJECTION |
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
BAUSCH |
