药品注册申请号：214695
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES LTD
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 LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG No No AB 2022/03/31 2022/03/31 Prescription
002 LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG No No AB 2022/03/31 Prescription
003 LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG No No AB 2022/03/31 Prescription
004 LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG No No AB 2022/03/31 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
2024/04/24 SUPPL-7（补充） Approval Labeling STANDARD
2024/04/24 SUPPL-6（补充） Approval Labeling STANDARD
2024/04/24 SUPPL-4（补充） Approval Labeling STANDARD
2024/04/24 SUPPL-2（补充） Approval Labeling STANDARD
2022/03/31 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:LACOSAMIDE 剂型/给药途径:TABLET;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
022253 001 NDA VIMPAT LACOSAMIDE TABLET;ORAL 50MG Prescription Yes No AB 2008/10/28 UCB INC
204787 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 HETERO LABS LTD V
204857 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Discontinued No No AB 2022/03/17 AMNEAL PHARMS
204921 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 MSN LABS PVT LTD
204974 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 ALEMBIC
205006 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 GLENMARK PHARMS LTD
205031 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 SUN PHARM
205237 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 SCIEGEN PHARMS INC
208308 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/17 INDOCO
214695 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2022/03/31 ALKEM LABS LTD
205011 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Discontinued No No AB 2022/07/12 ACCORD HLTHCARE
214567 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Discontinued No No AB 2022/09/23 APOTEX
204994 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2023/01/05 AUROBINDO PHARMA LTD
204855 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Discontinued No No AB 2023/01/05 ACTAVIS LABS FL INC
204947 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Discontinued No No AB 2023/12/15 ZYDUS PHARMS
218014 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2024/04/02 KANCHAN HLTHCARE
208466 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2024/05/24 MACLEODS PHARMS LTD
213109 001 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 50MG Prescription No No AB 2024/09/04 UNICHEM
活性成分:LACOSAMIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
022253 002 NDA VIMPAT LACOSAMIDE TABLET;ORAL 100MG Prescription Yes No AB 2008/10/28 UCB INC
204787 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 HETERO LABS LTD V
204857 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Discontinued No No AB 2022/03/17 AMNEAL PHARMS
204921 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 MSN LABS PVT LTD
204974 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 ALEMBIC
205006 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 GLENMARK PHARMS LTD
205031 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 SUN PHARM
205237 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 SCIEGEN PHARMS INC
208308 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/17 INDOCO
214695 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2022/03/31 ALKEM LABS LTD
205011 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Discontinued No No AB 2022/07/12 ACCORD HLTHCARE
214567 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Discontinued No No AB 2022/09/23 APOTEX
204994 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2023/01/05 AUROBINDO PHARMA LTD
204855 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Discontinued No No AB 2023/01/05 ACTAVIS LABS FL INC
204947 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Discontinued No No AB 2023/12/15 ZYDUS PHARMS
218014 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2024/04/02 KANCHAN HLTHCARE
208466 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2024/05/24 MACLEODS PHARMS LTD
213109 002 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 100MG Prescription No No AB 2024/09/04 UNICHEM
活性成分:LACOSAMIDE 剂型/给药途径:TABLET;ORAL 规格:150MG 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
022253 003 NDA VIMPAT LACOSAMIDE TABLET;ORAL 150MG Prescription Yes No AB 2008/10/28 UCB INC
204787 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 HETERO LABS LTD V
204857 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Discontinued No No AB 2022/03/17 AMNEAL PHARMS
204921 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 MSN LABS PVT LTD
204974 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 ALEMBIC
205006 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 GLENMARK PHARMS LTD
205031 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 SUN PHARM
205237 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 SCIEGEN PHARMS INC
208308 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/17 INDOCO
214695 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2022/03/31 ALKEM LABS LTD
205011 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Discontinued No No AB 2022/07/12 ACCORD HLTHCARE
214567 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Discontinued No No AB 2022/09/23 APOTEX
204994 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2023/01/05 AUROBINDO PHARMA LTD
204855 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Discontinued No No AB 2023/01/05 ACTAVIS LABS FL INC
204947 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Discontinued No No AB 2023/12/15 ZYDUS PHARMS
218014 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2024/04/02 KANCHAN HLTHCARE
208466 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2024/05/24 MACLEODS PHARMS LTD
213109 003 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 150MG Prescription No No AB 2024/09/04 UNICHEM
活性成分:LACOSAMIDE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
022253 004 NDA VIMPAT LACOSAMIDE TABLET;ORAL 200MG Prescription Yes Yes AB 2008/10/28 UCB INC
204787 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 HETERO LABS LTD V
204857 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Discontinued No No AB 2022/03/17 AMNEAL PHARMS
204921 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 MSN LABS PVT LTD
204974 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 ALEMBIC
205006 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 GLENMARK PHARMS LTD
205031 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 SUN PHARM
205237 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 SCIEGEN PHARMS INC
208308 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/17 INDOCO
214695 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2022/03/31 ALKEM LABS LTD
205011 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Discontinued No No AB 2022/07/12 ACCORD HLTHCARE
214567 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Discontinued No No AB 2022/09/23 APOTEX
204994 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2023/01/05 AUROBINDO PHARMA LTD
204855 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Discontinued No No AB 2023/01/05 ACTAVIS LABS FL INC
204947 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Discontinued No No AB 2023/12/15 ZYDUS PHARMS
218014 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2024/04/02 KANCHAN HLTHCARE
208466 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2024/05/24 MACLEODS PHARMS LTD
213109 004 ANDA LACOSAMIDE LACOSAMIDE TABLET;ORAL 200MG Prescription No No AB 2024/09/04 UNICHEM
更多信息
药品NDC数据与药品包装、标签说明书
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