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 |
|---|
| 2003/03/19 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/04/12 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/12/04 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/04/12 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/12/18 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/12/05 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/10/02 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/12/02 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/05/19 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/02/04 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/06/23 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/12/31 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/12/02 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/07/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/07/02 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/08/03 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/04/17 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/12/08 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1988/10/20 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
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:POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:10,000 UNITS/ML;EQ 1MG BASE/ML 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 |
|---|
| 050567 |
001 |
NDA |
POLYTRIM |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
10,000 UNITS/ML;EQ 1MG BASE/ML |
Discontinued |
Yes |
No |
AT |
1988/10/20
|
ALLERGAN |
| 064120 |
001 |
ANDA |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
10,000 UNITS/ML;EQ 1MG BASE/ML |
Prescription |
No |
No |
AT |
1997/02/14
|
BAUSCH AND LOMB |
| 064211 |
001 |
ANDA |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
10,000 UNITS/ML;EQ 1MG BASE/ML |
Prescription |
No |
Yes |
AT |
1998/04/13
|
SANDOZ |
| 065006 |
001 |
ANDA |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
10,000 UNITS/ML;EQ 1MG BASE/ML |
Prescription |
No |
No |
AT |
1998/12/17
|
EPIC PHARMA LLC |
| 211572 |
001 |
ANDA |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
10,000 UNITS/ML;EQ 1MG BASE/ML |
Prescription |
No |
No |
AT |
2024/08/05
|
SOMERSET THERAPS LLC |