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 |
|---|
| 2024/05/01 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/04/25 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/04/25 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/02/09 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/12/20 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:AMOXICILLIN; CLAVULANATE POTASSIUM 剂型/给药途径:FOR SUSPENSION;ORAL 规格:200MG/5ML;EQ 28.5MG BASE/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 |
|---|
| 065066 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2002/06/05
|
SANDOZ |
| 065098 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2002/12/16
|
SANDOZ INC |
| 065089 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2004/05/25
|
TEVA |
| 065191 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2005/01/25
|
HIKMA PHARMS |
| 201090 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2011/12/20
|
AUROBINDO PHARMA LTD |
| 205187 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
200MG/5ML;EQ 28.5MG BASE/5ML |
Prescription |
No |
No |
AB |
2021/05/21
|
MICRO LABS LTD INDIA |
活性成分:AMOXICILLIN; CLAVULANATE POTASSIUM 剂型/给药途径:FOR SUSPENSION;ORAL 规格:400MG/5ML;EQ 57MG BASE/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 |
|---|
| 065066 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2002/06/05
|
SANDOZ |
| 065098 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2002/12/16
|
SANDOZ INC |
| 065089 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
Yes |
AB |
2004/05/25
|
TEVA |
| 065191 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2005/01/25
|
HIKMA PHARMS |
| 201090 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2011/12/20
|
AUROBINDO PHARMA LTD |
| 205187 |
002 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2021/05/21
|
MICRO LABS LTD INDIA |
| 210416 |
001 |
ANDA |
AMOXICILLIN AND CLAVULANATE POTASSIUM |
AMOXICILLIN; CLAVULANATE POTASSIUM |
FOR SUSPENSION;ORAL |
400MG/5ML;EQ 57MG BASE/5ML |
Prescription |
No |
No |
AB |
2023/12/11
|
DEVA HOLDING AS |