药品注册申请号:091675
申请类型:ANDA (仿制药申请)
申请人:TRIS PHARMA INC
申请人全名:TRIS PHARMA 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 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No AA 2012/06/28 2012/06/28 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
2012/06/28 ORIG-1(原始申请) Approval
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:PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:6.25MG/5ML 治疗等效代码:AA
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
087953 001 ANDA PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription Yes Yes AA 1982/11/15 WOCKHARDT BIO AG
040026 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription No No AA 1998/09/25 CHARTWELL RX
040643 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Discontinued No No AA 2006/04/26 PHARM ASSOC
040718 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription No No AA 2007/04/04 TARO
040891 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription No No AA 2009/03/13 NOSTRUM LABS INC
040882 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Discontinued No No AA 2009/12/30 AMNEAL PHARMS
091675 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription No No AA 2012/06/28 TRIS PHARMA INC
213890 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML Prescription No No AA 2021/07/12 QUAGEN
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