药品注册申请号:211079
申请类型:ANDA (仿制药申请)
申请人:AMNEAL
申请人全名:AMNEAL EU 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 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) No No AP1 2018/07/05 2018/07/05 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
2020/09/01 SUPPL-6(补充) Approval Labeling STANDARD
2020/09/01 SUPPL-3(补充) Approval Labeling STANDARD
2018/07/05 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
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:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:10MG/ML (10MG/ML) 治疗等效代码:AP1
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
218412 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 -- HAINAN POLY
204300 001 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription Yes Yes AP1 2014/06/27 EXELA PHARMA
211079 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2018/07/05 AMNEAL
208905 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2019/01/31 SANDOZ
209967 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/01/16 SAGENT PHARMS INC
213318 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/06/11 CAPLIN
213237 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/07/01 ACCORD HLTHCARE
211081 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2020/07/17 PROVEPHARM SAS
211920 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2021/04/08 GLAND PHARMA LTD
217069 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP1 2022/08/30 MANKIND PHARMA
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