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 |
|---|
| 2024/02/27 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/07/24 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/07/24 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/09/24 |
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:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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 |
|---|
| 021278 |
001 |
NDA |
FOCALIN |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
Yes |
No |
AB |
2001/11/13
|
SANDOZ |
| 201231 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2015/09/24
|
SUN PHARM INDUSTRIES |
| 204534 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2015/12/04
|
NOVEL LABS INC |
| 206931 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2015/12/04
|
ABHAI INC |
| 207901 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2016/08/26
|
TRIS PHARMA INC |
| 208756 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2017/11/20
|
RHODES PHARMS |
| 212631 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2019/07/19
|
ALKEM LABS LTD |
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 021278 |
002 |
NDA |
FOCALIN |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
2001/11/13
|
SANDOZ |
| 201231 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/09/24
|
SUN PHARM INDUSTRIES |
| 204534 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/12/04
|
NOVEL LABS INC |
| 206931 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/12/04
|
ABHAI INC |
| 207901 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2016/08/26
|
TRIS PHARMA INC |
| 208756 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/11/20
|
RHODES PHARMS |
| 209211 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2018/09/19
|
CEDIPROF INC |
| 212631 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/07/19
|
ALKEM LABS LTD |
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 021278 |
003 |
NDA |
FOCALIN |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
Yes |
Yes |
AB |
2001/11/13
|
SANDOZ |
| 201231 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/09/24
|
SUN PHARM INDUSTRIES |
| 204534 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/12/04
|
NOVEL LABS INC |
| 206931 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/12/04
|
ABHAI INC |
| 207901 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2016/08/26
|
TRIS PHARMA INC |
| 208756 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/11/20
|
RHODES PHARMS |
| 209211 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/09/19
|
CEDIPROF INC |
| 212631 |
003 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/07/19
|
ALKEM LABS LTD |
