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 |
|---|
| 2024/06/24 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/22 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/22 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/06/23 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2008/09/03 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2007/01/24 |
ORIG-24（原始申请） |
Approval |
|
|
|
|
| 2007/01/24 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:SULFAMETHOXAZOLE; TRIMETHOPRIM 剂型/给药途径:SUSPENSION;ORAL 规格:200MG/5ML;40MG/5ML 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 |
|---|
| 018615 |
001 |
NDA |
SULFATRIM PEDIATRIC |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
1983/01/07
|
PHARM ASSOC |
| 074650 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Discontinued |
No |
No |
AB |
1997/12/29
|
HIKMA |
| 077612 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2006/11/13
|
PRASCO |
| 077785 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2007/01/24
|
CHARTWELL MOLECULAR |
| 091348 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
Yes |
AB |
2010/06/08
|
AUROBINDO PHARMA |
| 214330 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2022/02/08
|
NOVITIUM PHARMA |
活性成分:SULFAMETHOXAZOLE; TRIMETHOPRIM 剂型/给药途径:SUSPENSION;ORAL 规格:200MG/5ML;40MG/5ML 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 |
|---|
| 018615 |
001 |
NDA |
SULFATRIM PEDIATRIC |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
1983/01/07
|
PHARM ASSOC |
| 074650 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Discontinued |
No |
No |
AB |
1997/12/29
|
HIKMA |
| 077612 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2006/11/13
|
PRASCO |
| 077785 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2007/01/24
|
CHARTWELL MOLECULAR |
| 091348 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
Yes |
AB |
2010/06/08
|
AUROBINDO PHARMA |
| 214330 |
001 |
ANDA |
SULFAMETHOXAZOLE AND TRIMETHOPRIM |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUSPENSION;ORAL |
200MG/5ML;40MG/5ML |
Prescription |
No |
No |
AB |
2022/02/08
|
NOVITIUM PHARMA |