药品注册申请号：021278
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 DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Yes No AB 2001/11/13 2001/11/13 Prescription
002 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Yes No AB 2001/11/13 Prescription
003 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Yes Yes AB 2001/11/13 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-31（补充） Approval Labeling STANDARD
2023/10/13 SUPPL-28（补充） Approval Labeling STANDARD
2021/06/26 SUPPL-29（补充） Approval Labeling 901 REQUIRED
2019/11/19 SUPPL-26（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-19（补充） Approval Labeling STANDARD
2019/01/10 SUPPL-11（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-23（补充） Approval Labeling 901 REQUIRED
2016/05/13 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2015/12/04 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2015/04/17 SUPPL-18（补充） Approval Labeling 901 REQUIRED
2013/12/12 SUPPL-17（补充） Approval Labeling STANDARD
2013/06/11 SUPPL-16（补充） Approval Labeling STANDARD
2012/05/02 SUPPL-15（补充） Approval Labeling STANDARD
2010/12/09 SUPPL-13（补充） Approval Labeling STANDARD
2010/11/15 SUPPL-12（补充） Approval Labeling STANDARD
2007/04/25 SUPPL-8（补充） Approval Labeling STANDARD
2007/03/08 SUPPL-7（补充） Approval Labeling STANDARD
2006/08/24 SUPPL-5（补充） Approval Labeling STANDARD
2006/08/24 SUPPL-4（补充） Approval Labeling STANDARD
2002/01/03 SUPPL-1（补充） Approval Labeling STANDARD
2001/11/13 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 5908850 2015/12/04 U-422 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 5908850 2015/12/04 U-422 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 5908850 2015/12/04 U-422 PDF格式**本条是由Drugfuture回溯的历史信息**
6355656 2015/12/04 PDF格式**本条是由Drugfuture回溯的历史信息**
6528530 2015/12/04 Y 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
无
与本品治疗等效的药品
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
021278 001 NDA FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription Yes No AB 2001/11/13 SANDOZ
201231 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2015/09/24 SUN PHARM INDUSTRIES
204534 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2015/12/04 NOVEL LABS INC
206931 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2015/12/04 ABHAI INC
207901 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2016/08/26 TRIS PHARMA INC
208756 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2017/11/20 RHODES PHARMS
212631 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
活性成分:DEXMETHYLPHENIDATE 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RLDRSTE Code产品号批准日期申请人
021278 002 NDA FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB 2001/11/13 SANDOZ
201231 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/09/24 SUN PHARM INDUSTRIES
204534 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/12/04 NOVEL LABS INC
206931 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/12/04 ABHAI INC
207901 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2016/08/26 TRIS PHARMA INC
208756 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/11/20 RHODES PHARMS
209211 001 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/09/19 CEDIPROF INC
212631 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
活性成分:DEXMETHYLPHENIDATE 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RLDRSTE Code产品号批准日期申请人
021278 003 NDA FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes Yes AB 2001/11/13 SANDOZ
201231 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/09/24 SUN PHARM INDUSTRIES
204534 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/12/04 NOVEL LABS INC
206931 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/12/04 ABHAI INC
207901 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2016/08/26 TRIS PHARMA INC
208756 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/11/20 RHODES PHARMS
209211 002 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/09/19 CEDIPROF INC
212631 003 ANDA DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database