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 |
|---|
| 2000/05/09 |
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 |
|---|
| 2025/10/07 |
SUPPL-27（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2025/10/02 |
SUPPL-26（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2021/06/25 |
SUPPL-23（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/06/14 |
SUPPL-20（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/06/14 |
SUPPL-18（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/10/28 |
SUPPL-15（补充） |
Approval |
Labeling-Medication Guide,Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2016/10/28 |
SUPPL-13（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/03/20 |
SUPPL-12（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2014/01/21 |
SUPPL-10（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/12/19 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2010/12/10 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2003/04/24 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
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:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, 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 |
|---|
| 075629 |
001 |
ANDA |
METHYLIN ER |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2000/05/09
|
SPECGX LLC |
| 207488 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/06/09
|
ABHAI LLC |
| 204772 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2016/02/29
|
ALVOGEN |
| 210992 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/11/21
|
GRANULES |
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:20MG; 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 |
|---|
| 075629 |
002 |
ANDA |
METHYLIN ER |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2000/05/09
|
SPECGX LLC |
| 207488 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
Prescription |
No |
Yes |
AB |
2015/06/09
|
ABHAI LLC |
| 204772 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2016/02/29
|
ALVOGEN |
| 210992 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/11/21
|
GRANULES |
| 212288 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/10/06
|
ALKEM LABS LTD |
