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 |
|---|
| 2019/05/31 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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 ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:1.25MG;1.25MG;1.25MG;1.25MG; 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 |
|---|
| 206159 |
001 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
1.25MG;1.25MG;1.25MG;1.25MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |
>>>活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:2.5MG;2.5MG;2.5MG;2.5MG; 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 |
|---|
| 206159 |
002 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
2.5MG;2.5MG;2.5MG;2.5MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |
>>>活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:3.75MG;3.75MG;3.75MG;3.75MG; 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 |
|---|
| 206159 |
003 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
3.75MG;3.75MG;3.75MG;3.75MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |
>>>活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:5MG;5MG;5MG;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 |
|---|
| 206159 |
004 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG;5MG;5MG;5MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |
>>>活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:6.25MG;6.25MG;6.25MG;6.25MG; 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 |
|---|
| 206159 |
005 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
6.25MG;6.25MG;6.25MG;6.25MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |
>>>活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:7.5MG;7.5MG;7.5MG;7.5MG; 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 |
|---|
| 206159 |
006 |
ANDA |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE;ORAL |
7.5MG;7.5MG;7.5MG;7.5MG |
Discontinued |
No |
No |
AB |
2019/05/31
|
PH HEALTH |