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 |
2023/10/13 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/25 |
SUPPL-44(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2017/01/04 |
SUPPL-38(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2016/11/30 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/17 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/08/11 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/12/12 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/07/30 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/12 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/03 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/11/23 |
SUPPL-27(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/11/23 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/11/04 |
SUPPL-22(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2009/01/14 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/06/27 |
SUPPL-17(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2008/06/27 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/03 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/09/07 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/09/07 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/10/21 |
SUPPL-8(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2002/12/18 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/01 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/03/04 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/04/26 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/12/08 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/08/01 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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: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 |
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 |