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 |
|---|
| 1965/12/16 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity and Type 4 - New Combination |
PRIORITY
|
|
|
>>>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 |
|---|
| 2013/11/08 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2013/06/25 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2006/07/20 |
SUPPL-40（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
N/A
|
|
|
| 2000/07/26 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/02/11 |
SUPPL-37（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/02/12 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1996/03/29 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1994/09/30 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1989/01/27 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1986/06/12 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1986/01/31 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1984/11/09 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1984/08/03 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1984/01/09 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1983/07/05 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1982/09/27 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1982/09/27 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1982/06/18 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1981/12/17 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1980/10/14 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/10/06 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/06/06 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/05/29 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/07/27 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/12/08 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/03/01 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1975/11/14 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
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:TROMETHAMINE; 剂型/给药途径:SOLUTION;INJECTION; 规格:18GM/500ML (3.6GM/100ML); 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 |
|---|
| 013025 |
002 |
NDA |
THAM |
TROMETHAMINE |
SOLUTION;INJECTION |
18GM/500ML (3.6GM/100ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 211558 |
001 |
ANDA |
TROMETHAMINE |
TROMETHAMINE |
SOLUTION;INJECTION |
18GM/500ML (3.6GM/100ML) |
Prescription |
No |
No |
AP |
2024/12/09
|
B BRAUN MEDICAL |
| 213116 |
001 |
ANDA |
TROMETHAMINE |
TROMETHAMINE |
SOLUTION;INJECTION |
18GM/500ML (3.6GM/100ML) |
Prescription |
No |
No |
AP |
2024/12/31
|
MILLA PHARMS |
