药品注册申请号：212901
申请类型：ANDA (仿制药申请)
申请人：SENORES PHARMS
申请人全名：SENORES 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 AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG No No AA 2020/05/22 2020/05/22 Prescription
002 AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG No No AA 2020/05/22 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
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-3（补充） Approval Labeling STANDARD
2022/02/25 SUPPL-1（补充） Approval Labeling STANDARD
2020/05/22 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
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:AMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AA
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
200166 001 ANDA EVEKEO AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2012/08/09 AZURITY
211139 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2018/09/26 AMNEAL PHARMS
211639 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2019/04/17 AUROLIFE PHARMA LLC
212619 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2019/08/05 GRANULES
212919 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2019/11/22 BIONPHARMA
212582 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2020/02/04 SANALUZ
211861 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2020/03/11 PRINSTON INC
212901 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2020/05/22 SENORES PHARMS
213720 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2020/10/27 ALKEM LABS LTD
213980 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2020/10/27 EPIC PHARMA LLC
213583 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2021/01/22 SPECGX LLC
214574 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Discontinued No No AA 2021/01/27 SUN PHARM INDS INC
213852 001 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2021/09/07 RHODES PHARMS
活性成分:AMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AA
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
200166 002 ANDA EVEKEO AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No Yes AA 2012/08/09 AZURITY
211139 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2018/09/26 AMNEAL PHARMS
211639 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2019/04/17 AUROLIFE PHARMA LLC
212619 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2019/08/05 GRANULES
212919 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2019/11/22 BIONPHARMA
212582 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2020/02/04 SANALUZ
211861 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2020/03/11 PRINSTON INC
212901 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2020/05/22 SENORES PHARMS
213720 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2020/10/27 ALKEM LABS LTD
213980 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2020/10/27 EPIC PHARMA LLC
213583 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2021/01/22 SPECGX LLC
214574 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Discontinued No No AA 2021/01/27 SUN PHARM INDS INC
213852 002 ANDA AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2021/09/07 RHODES PHARMS
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
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