药品注册申请号:204300
申请类型:NDA (新药申请)
申请人:AVADEL LEGACY
申请人全名:AVADEL LEGACY PHARMACEUTICALS LLC
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 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Yes Yes AP 2014/06/27 2014/06/27 Prescription
002 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Yes Yes AP 2014/06/27 Prescription
003 VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Yes Yes AP1 2014/06/27 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
2019/10/18 SUPPL 8 Approval Labeling STANDARD
2015/10/29 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2015/05/28 SUPPL 5 Approval Labeling STANDARD
2015/01/02 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2014/06/27 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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:AP
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
204300 001 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription Yes Yes AP 2014/06/27 AVADEL LEGACY
210665 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP 2019/01/29 FRESENIUS KABI USA
活性成分:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:50MG/5ML (10MG/ML) 治疗等效代码:AP
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
204300 002 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription Yes Yes AP 2014/06/27 AVADEL LEGACY
活性成分:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:100MG/10ML (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
204300 003 NDA VAZCULEP PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription Yes Yes AP1 2014/06/27 AVADEL LEGACY
210333 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/04/27 MEITHEAL
211078 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/07/19 AMNEAL PHARMS CO
210025 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2018/12/21 PAR STERILE PRODUCTS
210666 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2019/01/30 FRESENIUS KABI USA
208905 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP1 2019/01/31 SANDOZ INC
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