药品注册申请号:204982
申请类型:ANDA (仿制药申请)
申请人:ACTAVIS LABS FL INC
申请人全名:ACTAVIS LABORATORIES FL 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 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 3.75MG BASE;23MG No No AB 2024/06/25 2024/06/25 Prescription
002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 7.5MG BASE;46MG No No AB 2024/06/25 Prescription
003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 11.25MG BASE;69MG No No AB 2024/06/25 Prescription
004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 15MG BASE;92MG No No AB 2024/06/25 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
2024/06/25 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
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
与本品治疗等效的药品
活性成分:PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 3.75MG BASE;23MG 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
022580 001 NDA QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 3.75MG BASE;23MG Prescription Yes No AB 2012/07/17 VIVUS LLC
204982 001 ANDA PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 3.75MG BASE;23MG Prescription No No AB 2024/06/25 ACTAVIS LABS FL INC
活性成分:PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 7.5MG BASE;46MG 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
022580 002 NDA QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 7.5MG BASE;46MG Prescription Yes No AB 2012/07/17 VIVUS LLC
204982 002 ANDA PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 7.5MG BASE;46MG Prescription No No AB 2024/06/25 ACTAVIS LABS FL INC
活性成分:PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 11.25MG BASE;69MG 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
022580 003 NDA QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 11.25MG BASE;69MG Prescription Yes No AB 2012/07/17 VIVUS LLC
204982 003 ANDA PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 11.25MG BASE;69MG Prescription No No AB 2024/06/25 ACTAVIS LABS FL INC
活性成分:PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 15MG BASE;92MG 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
022580 004 NDA QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 15MG BASE;92MG Prescription Yes Yes AB 2012/07/17 VIVUS LLC
204982 004 ANDA PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL EQ 15MG BASE;92MG Prescription No No AB 2024/06/25 ACTAVIS LABS FL INC
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