药品注册申请号:206608
申请类型:ANDA (仿制药申请)
申请人:MYLAN LABS LTD
申请人全名:MYLAN LABORATORIES 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 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML No No AP 2018/06/08 2018/06/08 Prescription
002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML No No AP 2018/06/08 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
2024/03/19 SUPPL-12(补充) Approval Labeling STANDARD
2018/06/08 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:ESMOLOL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/100ML 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
019386 004 NDA BREVIBLOC IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription Yes Yes AP 2001/02/16 BAXTER HLTHCARE
206608 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription No No AP 2018/06/08 MYLAN LABS LTD
207107 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription No No AP 2018/06/08 SAGENT PHARMS INC
216244 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription No No AP 2022/03/21 EUGIA PHARMA
214172 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription No No AP 2022/12/02 HQ SPCLT PHARMA
216603 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Prescription No No AP 2022/12/13 AMNEAL
活性成分:ESMOLOL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/100ML 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
019386 005 NDA BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription Yes Yes AP 2003/01/27 BAXTER HLTHCARE
206608 002 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription No No AP 2018/06/08 MYLAN LABS LTD
207107 002 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription No No AP 2018/06/08 SAGENT PHARMS INC
216244 002 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription No No AP 2022/03/21 EUGIA PHARMA
214172 002 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription No No AP 2022/12/02 HQ SPCLT PHARMA
216603 002 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Prescription No No AP 2022/12/13 AMNEAL
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