药品注册申请号:208202
申请类型:ANDA (仿制药申请)
申请人:ALEMBIC
申请人全名:ALEMBIC PHARMACEUTICALS 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 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2020/01/10 2020/01/10 Prescription
002 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2020/01/10 Prescription
003 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG No No AB 2020/01/10 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
2024/01/03 SUPPL-8(补充) Approval Labeling STANDARD
2023/07/18 SUPPL-4(补充) Approval Labeling STANDARD
2023/07/18 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2023/07/18 SUPPL-1(补充) Approval Labeling STANDARD
2020/01/10 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:VILAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;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
022567 001 NDA VIIBRYD VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes Yes AB 2011/01/21 ABBVIE
208212 001 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/09/30 TEVA PHARMS USA
208202 001 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/01/10 ALEMBIC
208200 001 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/04/07 INVAGEN PHARMS
208209 001 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/04/27 ACCORD HLTHCARE
208228 001 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/07/07 APOTEX
活性成分:VILAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;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
022567 002 NDA VIIBRYD VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription Yes No AB 2011/01/21 ABBVIE
208212 002 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2019/09/30 TEVA PHARMS USA
208202 002 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2020/01/10 ALEMBIC
208209 002 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2021/04/27 ACCORD HLTHCARE
208200 003 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2022/12/06 INVAGEN PHARMS
208228 002 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2023/07/07 APOTEX
活性成分:VILAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;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
022567 003 NDA VIIBRYD VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription Yes No AB 2011/01/21 ABBVIE
208212 003 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2019/09/30 TEVA PHARMS USA
208202 003 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2020/01/10 ALEMBIC
208200 002 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2021/04/07 INVAGEN PHARMS
208209 003 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2021/04/27 ACCORD HLTHCARE
208228 003 ANDA VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2023/07/07 APOTEX
更多信息
药品NDC数据与药品包装、标签说明书
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