药品注册申请号:040674
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA 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 PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML No No AA 2014/12/23 2014/12/23 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
2023/12/15 SUPPL-12(补充) Approval Labeling STANDARD
2018/06/28 SUPPL-7(补充) Approval Labeling STANDARD
2018/06/22 SUPPL-6(补充) Approval Labeling STANDARD
2017/08/29 SUPPL-5(补充) Approval Labeling STANDARD
2017/08/29 SUPPL-3(补充) Approval Labeling STANDARD
2017/01/13 SUPPL-2(补充) Approval Labeling STANDARD
2014/12/23 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:CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:10MG/5ML;5MG/5ML;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
040660 001 ANDA PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML Prescription No Yes AA 2006/12/07 PHARM ASSOC
040674 001 ANDA PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML Prescription No No AA 2014/12/23 HIKMA
200963 001 ANDA PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML Prescription No No AA 2015/08/26 AMNEAL PHARMS
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药品NDC数据与药品包装、标签说明书
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