药品注册申请号：203972
申请类型：ANDA (仿制药申请)
申请人：ENDO OPERATIONS
申请人全名：ENDO OPERATIONS LTD
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 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No AP 2014/08/18 2014/08/18 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
2024/05/01 SUPPL-15（补充） Approval Labeling STANDARD
2024/05/01 SUPPL-14（补充） Approval Labeling STANDARD
2021/03/29 SUPPL-9（补充） Approval Labeling STANDARD
2021/03/29 SUPPL-3（补充） Approval Labeling STANDARD
2014/08/18 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
无
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
无
与本品治疗等效的药品
活性成分:DEXMEDETOMIDINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MCG BASE/2ML (EQ 100MCG 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
021038 001 NDA PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription Yes Yes AP 1999/12/17 HOSPIRA
202881 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/08/18 MYLAN INSTITUTIONAL
203972 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/08/18 ENDO OPERATIONS
202585 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2014/11/24 RISING
202126 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2015/08/20 GLAND
201072 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2015/09/18 FRESENIUS KABI USA
204023 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/02/09 ACCORD HLTHCARE
205867 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/03/17 EUGIA PHARMA
091465 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/06/14 SANDOZ
204686 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2016/10/17 ACTAVIS INC
205046 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/04/26 HIKMA
209065 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/09/19 HENGRUI PHARMA
205272 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2017/11/28 TEVA PHARMS USA
206798 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2018/02/27 ZYDUS PHARMS
204843 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Prescription No No AP 2019/01/18 MEITHEAL
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药品NDC数据与药品包装、标签说明书
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