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 |