药品注册申请号:203826
申请类型:NDA (新药申请)
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 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Yes Yes AP2 2012/12/20 2012/12/20 Prescription
002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Yes Yes AP2 2019/06/19 Prescription
003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Yes Yes AP2 2019/06/19 Prescription
004 IMMPHENTIV PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 0.5MG/5ML (0.1MG/ML) Yes Yes None 2023/03/09 Prescription
005 IMMPHENTIV PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 1MG/10ML (0.1MG/ML) Yes Yes None 2023/03/09 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
2023/03/09 SUPPL-17(补充) Approval Labeling STANDARD
2023/03/09 SUPPL-15(补充) Approval Manufacturing (CMC) N/A
2019/06/19 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2016/12/09 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2016/09/06 SUPPL-2(补充) Approval Labeling STANDARD
2015/02/16 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2014/10/23 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2012/12/20 ORIG-1(原始申请) Approval Type 7 - Drug Already Marketed without Approved NDA 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
004 11213480 2036/09/26 Y 2023/03/22 PDF格式
11471400 2036/08/05 Y 2023/03/22 PDF格式
005 11213480 2036/09/26 Y 2023/03/22 PDF格式
11471400 2036/08/05 Y 2023/03/22 PDF格式
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:AP2
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
203826 001 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription Yes Yes AP2 2012/12/20 HIKMA
210334 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP2 2018/04/27 MEITHEAL
210665 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP2 2019/01/29 FRESENIUS KABI USA
210696 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP2 2021/01/07 EUGIA PHARMA
209968 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP2 2023/02/28 AVET LIFESCIENCES
217521 001 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) Prescription No No AP2 2023/06/26 BE PHARMS
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:AP2
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
203826 002 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription Yes Yes AP2 2019/06/19 HIKMA
217521 002 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP2 2023/06/26 BE PHARMS
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:AP2
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
203826 003 NDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription Yes Yes AP2 2019/06/19 HIKMA
217521 003 ANDA PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Prescription No No AP2 2023/06/26 BE PHARMS
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