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 |
|---|
| 2023/10/13 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/02/25 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/04 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/17 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/12 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/08/09 |
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:AMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AA
| 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 |
|---|
| 200166 |
001 |
ANDA |
EVEKEO |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2012/08/09
|
AZURITY |
| 211139 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2018/09/26
|
AMNEAL PHARMS |
| 211639 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2019/04/17
|
AUROLIFE PHARMA LLC |
| 212619 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2019/08/05
|
GRANULES |
| 212919 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2019/11/22
|
BIONPHARMA |
| 212582 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/02/04
|
CEROVENE INC |
| 211861 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/03/11
|
PRINSTON INC |
| 212901 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/05/22
|
SENORES PHARMS |
| 213720 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/10/27
|
ALKEM LABS LTD |
| 213980 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/10/27
|
EPIC PHARMA LLC |
| 213583 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2021/01/22
|
SPECGX LLC |
| 214574 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AA |
2021/01/27
|
SUN PHARM INDS INC |
| 213852 |
001 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2021/09/07
|
RHODES PHARMS |
活性成分:AMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AA
| 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 |
|---|
| 200166 |
002 |
ANDA |
EVEKEO |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
Yes |
AA |
2012/08/09
|
AZURITY |
| 211139 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2018/09/26
|
AMNEAL PHARMS |
| 211639 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2019/04/17
|
AUROLIFE PHARMA LLC |
| 212619 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2019/08/05
|
GRANULES |
| 212919 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2019/11/22
|
BIONPHARMA |
| 212582 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/02/04
|
CEROVENE INC |
| 211861 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/03/11
|
PRINSTON INC |
| 212901 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/05/22
|
SENORES PHARMS |
| 213720 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/10/27
|
ALKEM LABS LTD |
| 213980 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/10/27
|
EPIC PHARMA LLC |
| 213583 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2021/01/22
|
SPECGX LLC |
| 214574 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AA |
2021/01/27
|
SUN PHARM INDS INC |
| 213852 |
002 |
ANDA |
AMPHETAMINE SULFATE |
AMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2021/09/07
|
RHODES PHARMS |