药品注册申请号：021121
申请类型：NDA (新药申请)
申请人：JANSSEN PHARMS
申请人全名：JANSSEN PHARMACEUTICALS INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CONCERTA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 18MG Yes No AB 2000/08/01 2000/08/01 Prescription
002 CONCERTA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 36MG Yes No AB 2000/08/01 Prescription
003 CONCERTA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 54MG Yes Yes AB 2000/12/08 Prescription
004 CONCERTA METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 27MG Yes No AB 2002/04/01 Prescription
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）
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
001 6919373 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6919373*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8163798 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8163798*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8629179 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8629179*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038 2017/07/31 U-666 U-1693 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9029416 2017/07/31 Y U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9144549 2017/07/31 U-1748 U-1747 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6919373 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6919373*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8163798 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8163798*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8629179 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8629179*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038 2017/07/31 U-1693 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9029416 2017/07/31 Y U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9144549 2017/07/31 U-1748 U-1747 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6919373 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6919373*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8163798 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8163798*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8629179 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8629179*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038 2017/07/31 U-666 U-1693 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9029416 2017/07/31 Y U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9144549 2017/07/31 U-1748 U-1747 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6919373 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6919373*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129 2017/07/31 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
6930129*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8163798 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8163798*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
8629179 2017/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8629179*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038 2017/07/31 U-1693 U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9000038*PED 2018/01/31 PDF格式**本条是由Drugfuture回溯的历史信息**
9029416 2017/07/31 Y U-666 PDF格式**本条是由Drugfuture回溯的历史信息**
9144549 2017/07/31 U-1748 U-1747 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 D-94 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2011/06/27**本条是由Drugfuture回溯的历史信息**
PED 2008/04/21**本条是由Drugfuture回溯的历史信息**
002 D-94 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2011/06/27**本条是由Drugfuture回溯的历史信息**
PED 2008/04/21**本条是由Drugfuture回溯的历史信息**
003 D-94 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2011/06/27**本条是由Drugfuture回溯的历史信息**
PED 2008/04/21**本条是由Drugfuture回溯的历史信息**
004 D-94 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2007/10/21**本条是由Drugfuture回溯的历史信息**
NPP 2011/06/27**本条是由Drugfuture回溯的历史信息**
PED 2008/04/21**本条是由Drugfuture回溯的历史信息**
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RLDRSTE 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RLDRSTE 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RLDRSTE 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RLDRSTE 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
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