药品注册申请号:074524
申请类型:ANDA (仿制药申请)
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 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML No No AP 1996/03/22 1996/03/22 Prescription
002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML No No AP 1996/03/22 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
2023/04/12 SUPPL-19(补充) Approval Labeling STANDARD
2021/04/07 SUPPL-18(补充) Approval Labeling STANDARD
2020/06/03 SUPPL-15(补充) Approval Labeling STANDARD
2020/06/03 SUPPL-14(补充) Approval Labeling STANDARD
2012/10/11 SUPPL-10(补充) Approval Labeling STANDARD
2001/04/03 SUPPL-3(补充) Approval Manufacturing (CMC)
1999/09/24 SUPPL-1(补充) Approval Labeling
1996/03/22 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:KETAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/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
016812 002 NDA KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PAR STERILE PRODUCTS
074524 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 1996/03/22 HIKMA
074549 001 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 1996/06/27 HOSPIRA
076092 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 2001/12/28 EUGIA PHARMA
215808 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Discontinued No No AP 2023/01/13 FRESENIUS KABI USA
216809 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AP 2023/01/24 GLAND PHARMA LTD
活性成分:KETAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG BASE/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
016812 003 NDA KETALAR KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PAR STERILE PRODUCTS
074524 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 1996/03/22 HIKMA
074549 002 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 1996/06/27 HOSPIRA
076092 003 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 2002/10/25 EUGIA PHARMA
216809 003 ANDA KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AP 2023/01/24 GLAND PHARMA LTD
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