药品注册申请号：022063
申请类型：NDA (新药申请)
申请人：TAKEDA PHARMS USA
申请人全名：TAKEDA PHARMACEUTICALS USA 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 MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.125MG;3.125MG;3.125MG;3.125MG Yes No AB2 2017/06/20 2017/06/20 Prescription
002 MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Yes No AB2 2017/06/20 Prescription
003 MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 9.375MG;9.375MG;9.375MG;9.375MG Yes No AB2 2017/06/20 Prescription
004 MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 12.5MG;12.5MG;12.5MG;12.5MG Yes Yes AB2 2017/06/20 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-5（补充） Approval Labeling STANDARD
2022/02/25 SUPPL-3（补充） Approval Labeling 901 REQUIRED
2019/09/13 SUPPL-1（补充） Approval Efficacy PRIORITY
2017/06/20 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 8846100 2029/08/24 Y 2017/07/07 PDF格式
9173857 2026/05/12 U-2025 2017/07/07 PDF格式
002 8846100 2029/08/24 Y 2017/07/07 PDF格式
9173857 2026/05/12 U-2025 2017/07/07 PDF格式
003 8846100 2029/08/24 Y 2017/07/07 PDF格式
9173857 2026/05/12 U-2025 2017/07/07 PDF格式
004 8846100 2029/08/24 Y 2017/07/07 PDF格式
9173857 2026/05/12 U-2025 2017/07/07 PDF格式
001 6913768 2023/05/24 Y U-2025 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41148 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
RE42096 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 6913768 2023/05/24 Y U-2025 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41148 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
RE42096 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 6913768 2023/05/24 Y U-2025 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41148 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
RE42096 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 6913768 2023/05/24 Y U-2025 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41148 2018/10/21 Y PDF格式**本条是由Drugfuture回溯的历史信息**
RE42096 2018/10/21 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
001 M-248 2022/09/13**本条是由Drugfuture回溯的历史信息**
NP 2020/06/20**本条是由Drugfuture回溯的历史信息**
PED 2023/03/13**本条是由Drugfuture回溯的历史信息**
002 M-248 2022/09/13**本条是由Drugfuture回溯的历史信息**
NP 2020/06/20**本条是由Drugfuture回溯的历史信息**
PED 2023/03/13**本条是由Drugfuture回溯的历史信息**
003 M-248 2022/09/13**本条是由Drugfuture回溯的历史信息**
NP 2020/06/20**本条是由Drugfuture回溯的历史信息**
PED 2023/03/13**本条是由Drugfuture回溯的历史信息**
004 M-248 2022/09/13**本条是由Drugfuture回溯的历史信息**
NP 2020/06/20**本条是由Drugfuture回溯的历史信息**
PED 2023/03/13**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:3.125MG;3.125MG;3.125MG;3.125MG 治疗等效代码:AB2
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
022063 001 NDA MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.125MG;3.125MG;3.125MG;3.125MG Prescription Yes No AB2 2017/06/20 TAKEDA PHARMS USA
210876 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.125MG;3.125MG;3.125MG;3.125MG Prescription No No AB2 2022/01/31 TEVA PHARMS USA
211546 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.125MG;3.125MG;3.125MG;3.125MG Prescription No No AB2 2023/08/31 SPECGX LLC
215997 001 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 3.125MG;3.125MG;3.125MG;3.125MG Prescription No No AB2 2023/09/27 SUN PHARM INDS INC
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:6.25MG;6.25MG;6.25MG;6.25MG 治疗等效代码:AB2
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
022063 002 NDA MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription Yes No AB2 2017/06/20 TAKEDA PHARMS USA
210876 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB2 2022/01/31 TEVA PHARMS USA
211546 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB2 2023/08/31 SPECGX LLC
215997 002 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 6.25MG;6.25MG;6.25MG;6.25MG Prescription No No AB2 2023/09/27 SUN PHARM INDS INC
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:9.375MG;9.375MG;9.375MG;9.375MG 治疗等效代码:AB2
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
022063 003 NDA MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 9.375MG;9.375MG;9.375MG;9.375MG Prescription Yes No AB2 2017/06/20 TAKEDA PHARMS USA
210876 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 9.375MG;9.375MG;9.375MG;9.375MG Prescription No No AB2 2022/01/31 TEVA PHARMS USA
211546 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 9.375MG;9.375MG;9.375MG;9.375MG Prescription No No AB2 2023/08/31 SPECGX LLC
215997 003 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 9.375MG;9.375MG;9.375MG;9.375MG Prescription No No AB2 2023/09/27 SUN PHARM INDS INC
活性成分:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:12.5MG;12.5MG;12.5MG;12.5MG 治疗等效代码:AB2
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
022063 004 NDA MYDAYIS AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 12.5MG;12.5MG;12.5MG;12.5MG Prescription Yes Yes AB2 2017/06/20 TAKEDA PHARMS USA
210876 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 12.5MG;12.5MG;12.5MG;12.5MG Prescription No No AB2 2022/01/31 TEVA PHARMS USA
211546 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 12.5MG;12.5MG;12.5MG;12.5MG Prescription No No AB2 2023/08/31 SPECGX LLC
215997 004 ANDA DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL 12.5MG;12.5MG;12.5MG;12.5MG Prescription No No AB2 2023/09/27 SUN PHARM INDS INC
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