药品注册申请号：090533
申请类型：ANDA (仿制药申请)
申请人：AZURITY
申请人全名：AZURITY 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 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG No No AA 2011/10/25 2011/10/25 Prescription
002 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG No No AA 2011/10/25 Prescription
003 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG No No AA 2011/10/25 Prescription
004 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG No No AA 2011/10/25 Prescription
005 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 15MG No No AA 2011/10/25 Prescription
006 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 20MG No No AA 2011/10/25 Prescription
007 DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 30MG No No AA 2011/10/25 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-12（补充） Approval Labeling STANDARD
2022/02/25 SUPPL-11（补充） Approval Labeling STANDARD
2017/01/04 SUPPL-7（补充） Approval Labeling STANDARD
2015/04/17 SUPPL-5（补充） Approval Labeling STANDARD
2015/01/30 SUPPL-4（补充） Approval Labeling STANDARD
2011/10/25 ORIG-1（原始申请） Approval
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:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
090533 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG Prescription No No AA 2011/10/25 AZURITY
212160 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG Prescription No No AA 2021/06/07 WINDER LABS LLC
活性成分:DEXTROAMPHETAMINE 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
040361 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2001/01/31 BARR
040436 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2002/01/29 SPECGX LLC
090533 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2011/10/25 AZURITY
202893 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2013/07/31 AUROLIFE PHARMA LLC
203548 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2015/11/23 AVANTHI INC
204330 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2016/03/16 NOVEL LABS INC
210059 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2017/10/18 NUVO PHARM
212160 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Prescription No No AA 2021/06/07 WINDER LABS LLC
206095 001 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG Discontinued No No AA 2022/08/18 TRIS PHARMA INC
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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
090533 003 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG Prescription No No AA 2011/10/25 AZURITY
212160 003 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG Prescription No No AA 2021/06/07 WINDER LABS LLC
活性成分:DEXTROAMPHETAMINE 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
040361 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No Yes AA 2001/01/31 BARR
040436 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2002/01/29 SPECGX LLC
090533 004 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2011/10/25 AZURITY
202893 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2013/07/31 AUROLIFE PHARMA LLC
203548 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2015/11/23 AVANTHI INC
204330 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2016/03/16 NOVEL LABS INC
210059 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2017/10/18 NUVO PHARM
212160 004 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Prescription No No AA 2021/06/07 WINDER LABS LLC
206095 002 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG Discontinued No No AA 2022/08/18 TRIS PHARMA INC
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:15MG 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
090533 005 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 15MG Prescription No No AA 2011/10/25 AZURITY
212160 005 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 15MG Prescription No No AA 2021/06/07 WINDER LABS LLC
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:20MG 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
090533 006 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 20MG Prescription No No AA 2011/10/25 AZURITY
212160 006 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 20MG Prescription No No AA 2021/06/07 WINDER LABS LLC
活性成分:DEXTROAMPHETAMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:30MG 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
090533 007 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 30MG Prescription No No AA 2011/10/25 AZURITY
212160 007 ANDA DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET;ORAL 30MG Prescription No No AA 2021/06/07 WINDER LABS LLC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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