药品注册申请号:203725
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA FARMACEUTICA PORTUGAL SA
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 VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL No No AP 2019/07/30 2019/07/30 Prescription
002 VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL No No AP 2019/07/30 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
2019/07/30 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:VECURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/VIAL 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
074688 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 1999/08/25 MEITHEAL
075164 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 1999/10/21 HOSPIRA
075549 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2000/06/13 HIKMA
078274 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2008/12/29 SAGENT PHARMS INC
079001 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No Yes AP 2009/06/17 SUN PHARM
090243 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2010/05/11 MYLAN LABS LTD
205390 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2016/05/26 GLAND
206670 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2018/12/20 EUGIA PHARMA
203725 001 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL Prescription No No AP 2019/07/30 HIKMA
活性成分:VECURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/VIAL 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
074688 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 1999/08/25 MEITHEAL
075164 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 1999/10/21 HOSPIRA
075549 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2000/06/13 HIKMA
078274 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2008/12/29 SAGENT PHARMS INC
079001 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No Yes AP 2009/06/17 SUN PHARM
090243 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2010/05/11 MYLAN LABS LTD
205390 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2016/05/26 GLAND
206670 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2018/12/20 EUGIA PHARMA
203725 002 ANDA VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2019/07/30 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database