药品注册申请号：213927
申请类型：ANDA (仿制药申请)
申请人：ADAPTIS
申请人全名：ADAPTIS PHARMA PRIVATE 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 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE No No AB 2021/01/21 2021/01/21 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/01/21 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；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-3（补充） Approval Labeling-Patient Package Insert,Labeling-Medication Guide STANDARD
2022/12/13 SUPPL-1（补充） Approval Labeling-Package Insert 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:VENLAFAXINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 75MG BASE; 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
022104 002 NDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription Yes No AB 2008/05/20 OSMOTICA PHARM US
091272 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2010/08/18 SUN PHARM
211323 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2019/08/29 CADILA PHARMS LTD
214419 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2020/10/21 ASCENT PHARMS INC
213927 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2021/01/21 ADAPTIS
214127 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2021/06/10 ALKEM LABS LTD
214423 001 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2022/01/04 SWISS PHARM
215622 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2022/08/30 ZYDUS PHARMS
216044 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2022/11/28 UNIQUE
214691 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Prescription No No AB 2023/04/12 AJANTA PHARMA LTD
218180 002 ANDA VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 75MG BASE Discontinued No No AB 2025/01/28 TORRENT
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database