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-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/08/01 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/08/14 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/07/31 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/07/31 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/12/04 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/11/05 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/10/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/04/02 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/11/30 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/16 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/01/19 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/30 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/26 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/12/08 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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 |
001 |
5169849 |
2009/12/08 |
|
|
U-227 |
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
与本品治疗等效的药品
活性成分:DIHYDROERGOTAMINE MESYLATE 剂型/给药途径:SPRAY, METERED;NASAL 规格:0.5MG/SPRAY 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 |
020148 |
001 |
NDA |
MIGRANAL |
DIHYDROERGOTAMINE MESYLATE |
SPRAY, METERED;NASAL |
0.5MG/SPRAY |
Prescription |
Yes |
Yes |
AB |
1997/12/08
|
BAUSCH |
211393 |
001 |
ANDA |
DIHYDROERGOTAMINE MESYLATE |
DIHYDROERGOTAMINE MESYLATE |
SPRAY, METERED;NASAL |
0.5MG/SPRAY |
Prescription |
No |
No |
AB |
2020/02/28
|
HIKMA |
212907 |
001 |
ANDA |
DIHYDROERGOTAMINE MESYLATE |
DIHYDROERGOTAMINE MESYLATE |
SPRAY, METERED;NASAL |
0.5MG/SPRAY |
Prescription |
No |
No |
AB |
2020/05/20
|
CIPLA |
214105 |
001 |
ANDA |
DIHYDROERGOTAMINE MESYLATE |
DIHYDROERGOTAMINE MESYLATE |
SPRAY, METERED;NASAL |
0.5MG/SPRAY |
Discontinued |
No |
No |
AB |
2022/01/04
|
AMNEAL |
216881 |
001 |
ANDA |
DIHYDROERGOTAMINE MESYLATE |
DIHYDROERGOTAMINE MESYLATE |
SPRAY, METERED;NASAL |
0.5MG/SPRAY |
Prescription |
No |
No |
AB |
2023/06/22
|
RUBICON |