药品注册申请号：073137
申请类型：ANDA (仿制药申请)
申请人：SUN PHARM INDUSTRIES
申请人全名：SUN PHARMACEUTICAL INDUSTRIES 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 100MG No No AB 1993/03/24 1993/03/24 Prescription
002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG No No AB 1993/03/24 Prescription
003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 1995/12/22 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
1993/03/24 ORIG-1（原始申请） Approval
>>>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
2025/06/24 SUPPL-47（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/06/07 SUPPL-42（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/06/07 SUPPL-41（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2014/07/17 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2014/06/25 SUPPL-33（补充） Approval Labeling-Package Insert STANDARD
2013/07/30 SUPPL-32（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2007/11/13 SUPPL-28（补充） Approval Labeling
2007/11/13 SUPPL-27（补充） Approval Labeling
2007/06/25 SUPPL-26（补充） Approval Labeling
2005/08/26 SUPPL-22（补充） Approval Labeling
2005/05/05 SUPPL-21（补充） Approval Labeling
2003/05/07 SUPPL-15（补充） Approval Labeling
2002/02/14 SUPPL-12（补充） Approval Manufacturing (CMC)-Control
2001/03/13 SUPPL-11（补充） Approval Labeling
2000/05/16 SUPPL-10（补充） Approval Manufacturing (CMC)-Facility
2000/05/16 SUPPL-9（补充） Approval Manufacturing (CMC)-Facility
1998/04/27 SUPPL-8（补充） Approval Manufacturing (CMC)
1998/04/27 SUPPL-7（补充） Approval Manufacturing (CMC)
1998/04/27 SUPPL-6（补充） Approval Manufacturing (CMC)
1998/02/04 SUPPL-4（补充） Approval Manufacturing (CMC)
1997/12/05 SUPPL-5（补充） Approval Manufacturing (CMC)
1997/02/24 SUPPL-3（补充） Approval Manufacturing (CMC)
1995/06/22 SUPPL-2（补充） Approval Manufacturing (CMC)
1994/01/12 SUPPL-1（补充） Approval Manufacturing (CMC)
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: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
211116 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2024/05/20 CROSSMEDIKA SA
218988 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2024/08/08 GRANULES
217740 002 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2024/08/27 GRAVITI PHARMS
>>>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
211116 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2024/05/20 CROSSMEDIKA SA
218988 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2024/08/08 GRANULES
217740 001 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2024/08/27 GRAVITI PHARMS
>>>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
211116 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2024/05/20 CROSSMEDIKA SA
218988 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2024/08/08 GRANULES
217740 003 ANDA TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2024/08/27 GRAVITI PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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