药品注册申请号:088811
申请类型:ANDA (仿制药申请)
申请人:WOCKHARDT BIO AG
申请人全名:WOCKHARDT BIO AG
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 BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML No Yes AA 1985/06/07 1985/06/07 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/06/03 SUPPL 26 Approval Labeling STANDARD
2016/06/03 SUPPL 19 Approval Manufacturing (CMC)
2016/06/03 SUPPL 18 Approval Labeling
2004/09/30 SUPPL 13 Approval Labeling
1999/01/12 SUPPL 10 Approval Labeling
1994/03/04 SUPPL 9 Approval Labeling
1991/08/19 SUPPL 8 Approval Labeling
1989/05/10 SUPPL 6 Approval Labeling
1989/04/05 SUPPL 5 Approval Manufacturing (CMC)
1988/08/17 SUPPL 4 Approval Manufacturing (CMC)
1987/05/15 SUPPL 3 Approval Manufacturing (CMC)
1987/05/15 SUPPL 2 Approval Manufacturing (CMC)
1986/08/08 SUPPL 1 Approval Manufacturing (CMC)
1985/06/07 ORIG 1 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: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
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 AA -- WES PHARMA INC
088811 001 ANDA BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML;10MG/5ML;30MG/5ML Prescription No Yes 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 No AA 2014/07/15 PADDOCK LLC
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 MAYNE PHARMA INC
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 LANNETT CO INC
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