药品注册申请号:207901
申请类型:ANDA (仿制药申请)
申请人:TRIS PHARMA INC
申请人全名:TRIS PHARMA 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 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG No No AB 2016/08/26 2016/08/26 Prescription
002 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2016/08/26 Prescription
003 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2016/08/26 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
2024/06/28 SUPPL-10(补充) Approval Labeling STANDARD
2024/06/28 SUPPL-6(补充) Approval Labeling STANDARD
2024/06/28 SUPPL-4(补充) Approval Labeling STANDARD
2019/11/29 SUPPL-3(补充) Approval Labeling STANDARD
2016/08/26 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
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
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
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