药品注册申请号:215635
申请类型:ANDA (仿制药申请)
申请人:NIVAGEN PHARMS INC
申请人全名:NIVAGEN PHARMACEUTICALS 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 REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL No No AP 2024/06/28 2024/06/28 Prescription
002 REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL No No AP 2024/06/28 Prescription
003 REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL No No AP 2024/06/28 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
2024/06/28 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:REMIFENTANIL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/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
020630 001 NDA ULTIVA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Prescription Yes No AP 1996/07/12 MYLAN INSTITUTIONAL
206223 001 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Prescription No No AP 2018/01/16 FRESENIUS KABI USA
210594 001 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Prescription No No AP 2020/10/13 HIKMA
215635 001 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Prescription No No AP 2024/06/28 NIVAGEN PHARMS INC
活性成分:REMIFENTANIL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2MG BASE/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
020630 002 NDA ULTIVA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL Prescription Yes No AP 1996/07/12 MYLAN INSTITUTIONAL
206223 002 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL Prescription No No AP 2018/01/16 FRESENIUS KABI USA
210594 002 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL Prescription No No AP 2020/10/13 HIKMA
215635 002 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/VIAL Prescription No No AP 2024/06/28 NIVAGEN PHARMS INC
活性成分:REMIFENTANIL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 5MG BASE/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
020630 003 NDA ULTIVA REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL Prescription Yes Yes AP 1996/07/12 MYLAN INSTITUTIONAL
206223 003 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL Prescription No No AP 2018/01/16 FRESENIUS KABI USA
210594 003 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL Prescription No No AP 2020/10/13 HIKMA
215635 003 ANDA REMIFENTANIL HYDROCHLORIDE REMIFENTANIL HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/VIAL Prescription No No AP 2024/06/28 NIVAGEN PHARMS INC
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