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 |
|---|
| 2014/09/26 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/09/28 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/05/26 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1994/09/30 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/09/14 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/11/14 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/03/26 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/05/18 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/10/30 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/06/26 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1985/01/24 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/28 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/19 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:ACETIC ACID, GLACIAL 剂型/给药途径:SOLUTION;IRRIGATION, URETHRAL 规格:250MG/100ML 治疗等效代码:AT
| 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 |
|---|
| 017656 |
001 |
NDA |
ACETIC ACID 0.25% IN PLASTIC CONTAINER |
ACETIC ACID, GLACIAL |
SOLUTION;IRRIGATION, URETHRAL |
250MG/100ML |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 018161 |
001 |
NDA |
ACETIC ACID 0.25% IN PLASTIC CONTAINER |
ACETIC ACID, GLACIAL |
SOLUTION;IRRIGATION, URETHRAL |
250MG/100ML |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
B BRAUN |
| 018523 |
001 |
NDA |
ACETIC ACID 0.25% IN PLASTIC CONTAINER |
ACETIC ACID, GLACIAL |
SOLUTION;IRRIGATION, URETHRAL |
250MG/100ML |
Prescription |
No |
No |
AT |
1982/02/19
|
BAXTER HLTHCARE |