药品注册申请号：217068
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 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG No No AB 2023/08/25 2023/08/25 Prescription
002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG No No AB 2023/08/25 Prescription
003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG No No AB 2023/08/25 Prescription
004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG No No AB 2023/08/25 Prescription
005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG No No AB 2023/08/25 Prescription
006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG No No AB 2023/08/25 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
2024/10/25 SUPPL-3（补充） Approval Labeling STANDARD
2023/08/25 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:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;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
219258 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription No No AB -- GRANULES
208510 001 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription Yes No AB 2017/01/28 TAKEDA PHARMS USA
214134 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG Prescription No No AB 2024/02/02 MSN
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;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
219258 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription No No AB -- GRANULES
208510 002 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription Yes No AB 2017/01/28 TAKEDA PHARMS USA
214134 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG Prescription No No AB 2024/02/02 MSN
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;ORAL 规格:30MG 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
219258 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription No No AB -- GRANULES
208510 003 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription Yes No AB 2017/01/28 TAKEDA PHARMS USA
214134 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG Prescription No No AB 2024/02/02 MSN
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;ORAL 规格:40MG 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
219258 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription No No AB -- GRANULES
208510 004 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription Yes No AB 2017/01/28 TAKEDA PHARMS USA
214134 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG Prescription No No AB 2024/02/02 MSN
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;ORAL 规格:50MG 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
219258 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription No No AB -- GRANULES
208510 005 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription Yes No AB 2017/01/28 TAKEDA PHARMS USA
214134 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG Prescription No No AB 2024/02/02 MSN
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:TABLET, CHEWABLE;ORAL 规格:60MG 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
219258 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription No No AB -- GRANULES
208510 006 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription Yes Yes AB 2017/01/28 TAKEDA PHARMS USA
214134 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
215415 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription No No AB 2023/08/25 TEVA PHARMS
217068 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
218306 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG Prescription No No AB 2024/02/02 MSN
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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