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 |
|---|
| 2024/04/01 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/06/23 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/06/23 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/11/13 |
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: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 |
|---|
| 010187 |
003 |
NDA |
RITALIN |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040300 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
1998/11/27
|
SPECGX LLC |
| 090710 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2012/03/15
|
SUN PHARM INDS INC |
| 091159 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/03/12
|
MOUNTAIN |
| 202892 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/09/23
|
OXFORD PHARMS |
| 207416 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/09/22
|
ASCENT PHARMS INC |
| 207884 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/11/13
|
NOVEL LABS INC |
| 206932 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/05/11
|
ABHAI INC |
| 209753 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2018/03/02
|
BIONPHARMA |
| 208737 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/02/01
|
CEDIPROF INC |
| 211779 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/10/04
|
ALKEM LABS LTD |
| 212697 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2020/07/23
|
PRINSTON INC |
| 213936 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2020/10/28
|
ACCORD HLTHCARE |
活性成分:METHYLPHENIDATE 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 |
|---|
| 010187 |
006 |
NDA |
RITALIN |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040300 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1998/11/27
|
SPECGX LLC |
| 090710 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2012/03/15
|
SUN PHARM INDS INC |
| 091159 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2014/03/12
|
MOUNTAIN |
| 202892 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2014/09/23
|
OXFORD PHARMS |
| 207416 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/09/22
|
ASCENT PHARMS INC |
| 207884 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/11/13
|
NOVEL LABS INC |
| 206932 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2017/05/11
|
ABHAI INC |
| 209753 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/03/02
|
BIONPHARMA |
| 208737 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/02/01
|
CEDIPROF INC |
| 211779 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/10/04
|
ALKEM LABS LTD |
| 212697 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/07/23
|
PRINSTON INC |
| 213936 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/10/28
|
ACCORD HLTHCARE |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 010187 |
010 |
NDA |
RITALIN |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040300 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1998/11/27
|
SPECGX LLC |
| 090710 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2012/03/15
|
SUN PHARM INDS INC |
| 091159 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2014/03/12
|
MOUNTAIN |
| 202892 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2014/09/23
|
OXFORD PHARMS |
| 207416 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/09/22
|
ASCENT PHARMS INC |
| 207884 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/11/13
|
NOVEL LABS INC |
| 206932 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/05/11
|
ABHAI INC |
| 209753 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/03/02
|
BIONPHARMA |
| 208737 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2019/02/01
|
CEDIPROF INC |
| 211779 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2019/10/04
|
ALKEM LABS LTD |
| 212697 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/07/23
|
PRINSTON INC |
| 213936 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/10/28
|
ACCORD HLTHCARE |
