药品注册申请号：021802
申请类型：NDA (新药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Yes No AB 2005/05/26 2005/05/26 Prescription
002 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Yes No AB 2005/05/26 Prescription
003 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Yes No AB 2005/05/26 Prescription
004 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Yes No AB 2006/08/01 Prescription
005 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Yes No AB 2009/10/23 Prescription
006 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Yes Yes AB 2010/08/11 Prescription
007 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Yes No AB 2011/04/21 Prescription
008 FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Yes No AB 2011/04/21 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-41（补充） Approval Labeling STANDARD
2023/10/13 SUPPL-38（补充） Approval Labeling STANDARD
2021/06/26 SUPPL-39（补充） Approval Labeling 901 REQUIRED
2019/11/19 SUPPL-36（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-29（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-19（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-33（补充） Approval Labeling 901 REQUIRED
2015/12/04 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2015/06/12 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2015/04/17 SUPPL-28（补充） Approval Labeling 901 REQUIRED
2013/12/12 SUPPL-26（补充） Approval Labeling STANDARD
2013/06/11 SUPPL-25（补充） Approval Labeling STANDARD
2012/05/02 SUPPL-24（补充） Approval Labeling STANDARD
2011/04/21 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2010/11/15 SUPPL-21（补充） Approval Labeling STANDARD
2010/05/04 SUPPL-17（补充） Approval Labeling UNKNOWN
2009/10/23 SUPPL-16（补充） Approval Labeling STANDARD
2009/10/23 SUPPL-14（补充） Approval Efficacy STANDARD
2008/10/17 SUPPL-12（补充） Approval Efficacy UNKNOWN
2007/04/25 SUPPL-9（补充） Approval Labeling STANDARD
2006/08/01 SUPPL-7（补充） Approval Manufacturing (CMC) N/A
2006/08/01 SUPPL-3（补充） Approval Labeling STANDARD
2006/04/11 SUPPL-5（补充） Approval Labeling STANDARD
2006/04/11 SUPPL-1（补充） Approval Efficacy UNKNOWN
2005/05/26 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 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
005 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 Y U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
006 5837284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 Y U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
007 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 Y U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
008 5837284 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5908850 2015/12/04 Y U-678 PDF格式**本条是由Drugfuture回溯的历史信息**
6228398 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635284 2015/12/04 Y U-677 PDF格式**本条是由Drugfuture回溯的历史信息**
6730325 2019/11/01 Y U-676 PDF格式**本条是由Drugfuture回溯的历史信息**
7431944 2015/12/04 Y 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 M-74 2009/04/11**本条是由Drugfuture回溯的历史信息**
M-80 2011/10/17**本条是由Drugfuture回溯的历史信息**
NDF 2008/05/26**本条是由Drugfuture回溯的历史信息**
002 M-74 2009/04/11**本条是由Drugfuture回溯的历史信息**
M-80 2011/10/17**本条是由Drugfuture回溯的历史信息**
NDF 2008/05/26**本条是由Drugfuture回溯的历史信息**
003 M-74 2009/04/11**本条是由Drugfuture回溯的历史信息**
M-80 2011/10/17**本条是由Drugfuture回溯的历史信息**
NDF 2008/05/26**本条是由Drugfuture回溯的历史信息**
004 M-74 2009/04/11**本条是由Drugfuture回溯的历史信息**
M-80 2011/10/17**本条是由Drugfuture回溯的历史信息**
NDF 2008/05/26**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:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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RLDRSTE Code产品号批准日期申请人
021802 001 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription Yes No AB 2005/05/26 SANDOZ
078908 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2013/11/19 TEVA PHARMS USA
079108 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2015/08/05 IMPAX LABS INC
202842 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2020/09/09 GRANULES
206734 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
078992 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2021/11/23 INTELLIPHARMACEUTICS
215523 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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RLDRSTE Code产品号批准日期申请人
021802 002 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription Yes No AB 2005/05/26 SANDOZ
078908 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2013/11/19 TEVA PHARMS USA
079108 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2015/08/05 IMPAX LABS INC
202842 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2020/09/09 GRANULES
206734 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
078992 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2021/11/23 INTELLIPHARMACEUTICS
215523 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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RLDRSTE Code产品号批准日期申请人
021802 003 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription Yes No AB 2005/05/26 SANDOZ
078908 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2013/11/19 TEVA PHARMS USA
079108 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2015/12/21 IMPAX LABS INC
202842 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2020/09/09 GRANULES
206734 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
078992 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2021/11/23 INTELLIPHARMACEUTICS
215523 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:15MG 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
021802 004 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription Yes No AB 2006/08/01 SANDOZ
078992 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2013/11/18 INTELLIPHARMACEUTICS
079108 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2014/05/19 IMPAX LABS INC
078908 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2014/05/19 TEVA PHARMS USA
202842 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2020/09/09 GRANULES
206734 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
215523 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:30MG 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
021802 005 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription Yes No AB 2009/10/23 SANDOZ
078992 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2013/11/18 INTELLIPHARMACEUTICS
079108 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2013/11/21 IMPAX LABS INC
202731 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2014/05/19 TEVA PHARMS USA
202842 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2020/09/09 GRANULES
206734 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
215523 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:40MG 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
021802 006 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription Yes Yes AB 2010/08/11 SANDOZ
202731 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2013/11/19 TEVA PHARMS USA
202842 008 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2016/11/30 PAR PHARM INC
210279 008 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 008 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2020/09/09 GRANULES
206734 008 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
078992 006 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2021/11/23 INTELLIPHARMACEUTICS
215523 008 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:35MG 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
021802 007 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription Yes No AB 2011/04/21 SANDOZ
202842 007 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2016/11/30 PAR PHARM INC
203614 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2017/07/05 IMPAX LABS INC
202731 004 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2017/07/05 TEVA PHARMS USA
210279 007 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 007 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2020/09/09 GRANULES
206734 007 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
215523 007 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 35MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:25MG 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
021802 008 NDA FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription Yes No AB 2011/04/21 SANDOZ
202842 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2016/11/30 PAR PHARM INC
203614 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2017/07/05 IMPAX LABS INC
202731 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2017/07/05 TEVA PHARMS USA
210279 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2018/10/09 ADARE PHARMS INC
213813 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2020/09/09 GRANULES
206734 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2021/11/05 SUN PHARM INDS INC
215523 005 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 25MG Prescription No No AB 2021/12/08 ASCENT PHARMS INC
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