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 |
2022/05/31 |
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, EXTENDED RELEASE;ORAL 规格:18MG 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 |
021121 |
001 |
NDA |
CONCERTA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
Yes |
No |
AB |
2000/08/01
|
JANSSEN PHARMS |
206726 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2016/10/21
|
AUROLIFE PHARMA LLC |
205327 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2017/07/28
|
OSMOTICA PHARM US |
076772 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2018/03/22
|
ACTAVIS LABS FL |
210818 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Discontinued |
No |
No |
AB |
2018/11/30
|
ALVOGEN |
211918 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2019/04/24
|
ANDOR PHARMS |
211009 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2019/09/03
|
ASCENT PHARMS INC |
213473 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2020/07/29
|
DR REDDYS |
205135 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2020/08/19
|
SUN PHARM INDS INC |
214111 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Discontinued |
No |
No |
AB |
2022/05/31
|
RHODES PHARMS |
214447 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Prescription |
No |
No |
AB |
2023/05/23
|
ALKEM LABS LTD |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:27MG 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 |
021121 |
004 |
NDA |
CONCERTA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
Yes |
No |
AB |
2002/04/01
|
JANSSEN PHARMS |
206726 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2016/10/21
|
AUROLIFE PHARMA LLC |
205327 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2017/07/28
|
OSMOTICA PHARM US |
076772 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2018/03/22
|
ACTAVIS LABS FL |
210818 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Discontinued |
No |
No |
AB |
2018/11/30
|
ALVOGEN |
211918 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2019/04/24
|
ANDOR PHARMS |
211009 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2019/09/03
|
ASCENT PHARMS INC |
213473 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2020/07/29
|
DR REDDYS |
205135 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2020/08/19
|
SUN PHARM INDS INC |
214111 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Discontinued |
No |
No |
AB |
2022/05/31
|
RHODES PHARMS |
214447 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Prescription |
No |
No |
AB |
2023/05/23
|
ALKEM LABS LTD |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:36MG 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 |
021121 |
002 |
NDA |
CONCERTA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
Yes |
No |
AB |
2000/08/01
|
JANSSEN PHARMS |
206726 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2016/10/21
|
AUROLIFE PHARMA LLC |
205327 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2017/07/28
|
OSMOTICA PHARM US |
076772 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2018/03/22
|
ACTAVIS LABS FL |
210818 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Discontinued |
No |
No |
AB |
2018/11/30
|
ALVOGEN |
211918 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2019/04/24
|
ANDOR PHARMS |
211009 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2019/09/03
|
ASCENT PHARMS INC |
213473 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2020/07/29
|
DR REDDYS |
205135 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2020/08/19
|
SUN PHARM INDS INC |
214111 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Discontinued |
No |
No |
AB |
2022/05/31
|
RHODES PHARMS |
214447 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Prescription |
No |
No |
AB |
2023/05/23
|
ALKEM LABS LTD |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:54MG 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 |
021121 |
003 |
NDA |
CONCERTA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
Yes |
Yes |
AB |
2000/12/08
|
JANSSEN PHARMS |
206726 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2016/10/21
|
AUROLIFE PHARMA LLC |
205327 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2017/07/28
|
OSMOTICA PHARM US |
076655 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2018/03/21
|
ACTAVIS LABS FL |
210818 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Discontinued |
No |
No |
AB |
2018/11/30
|
ALVOGEN |
211918 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2019/04/24
|
ANDOR PHARMS |
211009 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2019/09/03
|
ASCENT PHARMS INC |
213473 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2020/07/29
|
DR REDDYS |
205135 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2020/08/19
|
SUN PHARM INDS INC |
214111 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Discontinued |
No |
No |
AB |
2022/05/31
|
RHODES PHARMS |
214447 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Prescription |
No |
No |
AB |
2023/05/23
|
ALKEM LABS LTD |