药品注册申请号：205253
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA 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 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG No No AB 2017/10/10 2017/10/10 Prescription
002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2017/10/10 Prescription
003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 2017/10/10 Prescription
004 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG No No AB 2017/10/10 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
2024/02/29 SUPPL-21（补充） Tentative Approval Manufacturing (CMC) UNKNOWN
2022/10/18 SUPPL-18（补充） Approval Labeling STANDARD
2020/10/30 SUPPL-8（补充） Approval Labeling STANDARD
2020/04/20 SUPPL-4（补充） Approval Labeling STANDARD
2017/10/10 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
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:TRAZODONE HYDROCHLORIDE 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
071258 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1987/03/25 APOTEX
071523 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1987/12/11 TEVA PHARMS USA
072192 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1989/02/02 OXFORD PHARMS
073137 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1993/03/24 SUN PHARM INDUSTRIES
202180 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2013/11/27 TORRENT
206923 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/09/08 ACCORD HLTHCARE
205253 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/10/10 ZYDUS PHARMS
204852 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2020/02/05 AUROBINDO PHARMA
活性成分:TRAZODONE HYDROCHLORIDE 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
071196 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No Yes AB 1987/03/25 APOTEX INC
071524 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1987/12/11 TEVA PHARMS USA
072193 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1989/02/02 OXFORD PHARMS
073137 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1993/03/24 SUN PHARM INDUSTRIES
202180 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2013/11/27 TORRENT
206923 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/09/08 ACCORD HLTHCARE
205253 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/10/10 ZYDUS PHARMS
204852 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/02/05 AUROBINDO PHARMA
活性成分:TRAZODONE HYDROCHLORIDE 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
071525 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1988/03/09 PLIVA
073137 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1995/12/22 SUN PHARM INDUSTRIES
071196 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1999/04/26 APOTEX INC
202180 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2013/11/27 TORRENT
206923 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2017/09/08 ACCORD HLTHCARE
205253 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2017/10/10 ZYDUS PHARMS
204852 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2020/02/05 AUROBINDO PHARMA
活性成分:TRAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:300MG 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
071196 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 1999/04/26 APOTEX INC
202180 004 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2013/11/27 TORRENT
206923 004 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2017/09/08 ACCORD HLTHCARE
205253 004 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2017/10/10 ZYDUS PHARMS
204852 004 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2020/02/05 AUROBINDO PHARMA
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
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