药品注册申请号：207416
申请类型：ANDA (仿制药申请)
申请人：ASCENT PHARMS INC
申请人全名：ASCENT 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 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2015/09/22 2015/09/22 Prescription
002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2015/09/22 Prescription
003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2015/09/22 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2015/09/22 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/09/16 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2025/09/16 SUPPL-13（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2022/09/16 SUPPL-9（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2022/09/16 SUPPL-6（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2022/09/16 SUPPL-5（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2017/08/14 SUPPL-3（补充） Approval Labeling-Medication Guide,Labeling-Package Insert UNKNOWN
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
无
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:METHYLPHENIDATE 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
010187 003 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
040300 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2014/03/12 MOUNTAIN
202892 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/05/11 ABHAI LLC
209753 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
>>>活性成分:METHYLPHENIDATE 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
010187 006 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
040300 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2014/03/12 MOUNTAIN
202892 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/05/11 ABHAI LLC
209753 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
>>>活性成分:METHYLPHENIDATE HYDROCHLORIDE; 剂型/给药途径:TABLET;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
010187 010 NDA RITALIN METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SANDOZ
040300 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1998/11/27 SPECGX LLC
090710 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2012/03/15 SUN PHARM INDS INC
091159 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Discontinued No No AB 2014/03/12 MOUNTAIN
202892 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2014/09/23 OXFORD PHARMS
207416 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2015/09/22 ASCENT PHARMS INC
207884 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2015/11/13 NOVEL LABS INC
206932 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2017/05/11 ABHAI LLC
209753 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2018/03/02 BIONPHARMA
208737 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/02/01 CEDIPROF INC
211779 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/10/04 ALKEM LABS LTD
212697 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/07/23 PRINSTON INC
213936 003 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/10/28 ACCORD HLTHCARE
更多信息
药品NDC数据与药品包装、标签说明书
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