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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2013/07/31 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/03/08 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2022/02/25 |
SUPPL-4（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2017/01/04 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2015/04/17 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
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:DEXTROAMPHETAMINE 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 |
|---|
| 040361 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2001/01/31
|
BARR |
| 040436 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2002/01/29
|
SPECGX LLC |
| 090533 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2011/10/25
|
AZURITY |
| 202893 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2013/07/31
|
AUROLIFE PHARMA LLC |
| 203548 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2015/11/23
|
AVANTHI INC |
| 204330 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2016/03/16
|
NOVEL LABS INC |
| 210059 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2017/10/18
|
NUVO PHARM |
| 212160 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2021/06/07
|
WINDER LABS LLC |
| 206095 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AA |
2022/08/18
|
TRIS PHARMA INC |
>>>活性成分:DEXTROAMPHETAMINE 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 |
|---|
| 040361 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
Yes |
AA |
2001/01/31
|
BARR |
| 040436 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2002/01/29
|
SPECGX LLC |
| 090533 |
004 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2011/10/25
|
AZURITY |
| 202893 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2013/07/31
|
AUROLIFE PHARMA LLC |
| 203548 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2015/11/23
|
AVANTHI INC |
| 204330 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2016/03/16
|
NOVEL LABS INC |
| 210059 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2017/10/18
|
NUVO PHARM |
| 212160 |
004 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2021/06/07
|
WINDER LABS LLC |
| 206095 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AA |
2022/08/18
|
TRIS PHARMA INC |