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 |
|---|
| 2020/06/04 |
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:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:5MG/5ML 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 |
|---|
| 021419 |
001 |
NDA |
METHYLIN |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
Yes |
Yes |
AA |
2002/12/19
|
SPECGX LLC |
| 091601 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2010/07/23
|
TRIS PHARMA INC |
| 201466 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Discontinued |
No |
No |
AA |
2013/11/12
|
ALLIED |
| 204602 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2015/08/14
|
NOVEL LABS INC |
| 207485 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2016/11/18
|
ABHAI LLC |
| 210139 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2018/10/03
|
WES PHARMA INC |
| 211647 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2020/03/30
|
ALKEM LABS LTD |
| 210764 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2020/04/10
|
ANDA REPOSITORY |
| 213567 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2020/06/04
|
QUAGEN |
| 207417 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2021/01/29
|
ASCENT PHARMS INC |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:10MG/5ML 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 |
|---|
| 021419 |
002 |
NDA |
METHYLIN |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
Yes |
Yes |
AA |
2002/12/19
|
SPECGX LLC |
| 091601 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2010/07/23
|
TRIS PHARMA INC |
| 201466 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Discontinued |
No |
No |
AA |
2013/11/12
|
ALLIED |
| 204602 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2015/08/14
|
NOVEL LABS INC |
| 207485 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2016/11/18
|
ABHAI LLC |
| 210139 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2018/10/03
|
WES PHARMA INC |
| 211647 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2020/03/30
|
ALKEM LABS LTD |
| 210764 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2020/04/10
|
ANDA REPOSITORY |
| 213567 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2020/06/04
|
QUAGEN |
| 207417 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2021/01/29
|
ASCENT PHARMS INC |