药品注册申请号：210647
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES 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 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML No No AA 2020/07/14 2020/07/14 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
2020/07/14 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:BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:2MG/5ML;10MG/5ML;30MG/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
088811 001 ANDA BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription Yes No AA 1985/06/07 WOCKHARDT BIO AG
205292 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No Yes AA 2014/07/15 PADAGIS US
202940 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2014/07/21 PHARM ASSOC
203375 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2016/09/20 ACELLA
205112 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2017/02/27 TARO
207676 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2018/12/04 DR REDDYS LABS SA
213125 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2020/04/17 CHARTWELL MOLECULAR
211170 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2020/06/16 WES PHARMA INC
210647 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No No AA 2020/07/14 ALKEM LABS LTD
203997 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Discontinued No No AA 2020/09/30 BIONPHARMA
202955 001 ANDA BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Discontinued No No AA 2020/11/05 RHODES PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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