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-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/04/12 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/05/29 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/05/29 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/05/29 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/15 |
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:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:125MG/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 |
|---|
| 062226 |
001 |
ANDA |
AMOXIL |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
US ANTIBIOTICS |
| 062226 |
003 |
ANDA |
LAROTID |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
US ANTIBIOTICS |
| 062927 |
001 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Discontinued |
No |
No |
AB |
1988/11/25
|
ENDO OPERATIONS |
| 065322 |
002 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
2006/06/19
|
HIKMA |
| 065387 |
001 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
2007/03/26
|
SANDOZ |
| 204030 |
001 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
2014/09/15
|
AUROBINDO PHARMA LTD |
活性成分:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:250MG/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 |
|---|
| 061931 |
002 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
TEVA |
| 062226 |
002 |
ANDA |
AMOXIL |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
US ANTIBIOTICS |
| 062226 |
004 |
ANDA |
LAROTID |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
US ANTIBIOTICS |
| 062927 |
002 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Discontinued |
No |
No |
AB |
1988/11/25
|
ENDO OPERATIONS |
| 065322 |
001 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
No |
AB |
2006/06/19
|
HIKMA |
| 065387 |
002 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
No |
AB |
2007/03/26
|
SANDOZ |
| 204030 |
002 |
ANDA |
AMOXICILLIN |
AMOXICILLIN |
FOR SUSPENSION;ORAL |
250MG/5ML |
Prescription |
No |
No |
AB |
2014/09/15
|
AUROBINDO PHARMA LTD |