药品注册申请号：214547
申请类型：ANDA (仿制药申请)
申请人：NORWICH
申请人全名：NORWICH 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 CAPSULE;ORAL 10MG No No AB 2023/08/25 2023/08/25 Prescription
002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG No No AB 2023/08/25 Prescription
003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG No No AB 2023/08/25 Prescription
004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG No No AB 2023/08/25 Prescription
005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG No No AB 2023/08/25 Prescription
006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG No No AB 2023/08/25 Prescription
007 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG 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
2024/01/05 SUPPL-2（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:CAPSULE;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
021977 007 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription Yes No AB 2014/10/30 TAKEDA PHARMS USA
202802 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202835 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 MYLAN
211840 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 NORWICH
215330 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 APOTEX
217194 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202827 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2024/01/17 HIKMA
218604 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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
021977 004 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription Yes No AB 2007/12/10 TAKEDA PHARMS USA
202802 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 HIKMA
202830 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 AMNEAL
202835 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 MYLAN
211840 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 NORWICH
215330 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 APOTEX
217194 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 001 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Discontinued No No AB 2024/07/26 SANDOZ
218604 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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
021977 001 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription Yes No AB 2007/02/23 TAKEDA PHARMS USA
202802 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 HIKMA
202830 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 AMNEAL
202835 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 MYLAN
211840 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 NORWICH
215330 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 APOTEX
217194 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 002 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Discontinued No No AB 2024/07/26 SANDOZ
218604 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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
021977 005 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription Yes No AB 2007/12/10 TAKEDA PHARMS USA
202802 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 HIKMA
202830 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 AMNEAL
202835 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 MYLAN
211840 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 NORWICH
215330 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 APOTEX
217194 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 003 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Discontinued No No AB 2024/07/26 SANDOZ
218604 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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
021977 002 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription Yes No AB 2007/02/23 TAKEDA PHARMS USA
202802 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 HIKMA
202830 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 AMNEAL
202835 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 MYLAN
211840 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 NORWICH
215330 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 APOTEX
217194 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 004 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Discontinued No No AB 2024/07/26 SANDOZ
218604 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;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
021977 006 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription Yes No AB 2007/12/10 TAKEDA PHARMS USA
202802 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 HIKMA
202830 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 AMNEAL
202835 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 MYLAN
211840 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 NORWICH
215330 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 APOTEX
217194 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 005 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Discontinued No No AB 2024/07/26 SANDOZ
218604 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG Prescription No No AB 2024/11/15 ELITE LABS INC
活性成分:LISDEXAMFETAMINE DIMESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:70MG 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
021977 003 NDA VYVANSE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription Yes Yes AB 2007/02/23 TAKEDA PHARMS USA
202802 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 ACTAVIS ELIZABETH
202827 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 HIKMA
202830 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 AMNEAL
202835 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 MYLAN
211840 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 SPECGX LLC
214484 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 SUN PHARM INDS INC
214547 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 NORWICH
215330 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 RHODES PHARMS
215802 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 LANNETT CO INC
216266 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 PRINSTON INC
216944 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 APOTEX
217194 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 ALKEM LABS LTD
217442 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2023/08/25 ASCENT PHARMS INC
202836 006 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Discontinued No No AB 2024/07/26 SANDOZ
218604 007 ANDA LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG Prescription No No AB 2024/11/15 ELITE LABS INC
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