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-83（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/10/15 |
SUPPL-80（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/09/07 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| 2003/09/25 |
SUPPL-56（补充） |
Approval |
Labeling |
|
|
|
| 2001/02/07 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/11/13 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/21 |
SUPPL-51（补充） |
Approval |
Labeling |
|
|
|
| 1997/06/20 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/02/28 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/07 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1997/01/07 |
SUPPL-46（补充） |
Approval |
Labeling |
|
|
|
| 1997/01/07 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/07 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/07 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/07 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/11/08 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/12/19 |
SUPPL-38（补充） |
Approval |
Labeling |
|
|
|
| 1994/02/16 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1993/11/03 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/11/03 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/11/03 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/11/03 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/03/05 |
SUPPL-32（补充） |
Approval |
Bioequivalence |
|
|
|
| 1993/01/22 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/07/24 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/02/26 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/02/26 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/09/28 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/05/08 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1990/01/12 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1988/12/15 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/15 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/11/01 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1988/09/08 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/07/14 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/11/27 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/04/22 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/04/22 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/13 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/13 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/13 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/13 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/01/07 |
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 |
