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 |
|---|
| 2024/03/11 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/11 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/10/31 |
ORIG-1（原始申请） |
Approval |
|
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:CAPSULE, EXTENDED RELEASE;ORAL 规格:5MG 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 |
|---|
| 017078 |
001 |
NDA |
DEXEDRINE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
IMPAX LABS INC |
| 076353 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2003/05/06
|
SPECGX LLC |
| 203901 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2012/11/30
|
ACTAVIS ELIZABETH |
| 205673 |
001 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/10/31
|
STRIDES PHARMA |
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:10MG 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 |
|---|
| 017078 |
002 |
NDA |
DEXEDRINE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
IMPAX LABS INC |
| 076353 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2003/05/06
|
SPECGX LLC |
| 203901 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2012/11/30
|
ACTAVIS ELIZABETH |
| 205673 |
002 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/10/31
|
STRIDES PHARMA |
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:15MG 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 |
|---|
| 017078 |
003 |
NDA |
DEXEDRINE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
IMPAX LABS INC |
| 076353 |
003 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2003/05/06
|
SPECGX LLC |
| 203901 |
003 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2012/11/30
|
ACTAVIS ELIZABETH |
| 205673 |
003 |
ANDA |
DEXTROAMPHETAMINE SULFATE |
DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/10/31
|
STRIDES PHARMA |