药品注册申请号:019386
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:--
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
002 BREVIBLOC ESMOLOL HYDROCHLORIDE INJECTABLE; INJECTION 250MG/ML No None 1986/12/31 -- Discontinued
003 BREVIBLOC ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No None 1988/08/15 Discontinued
004 BREVIBLOC IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Yes Yes None 2001/02/16 Prescription
005 BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Yes Yes None 2003/01/27 Prescription
006 BREVIBLOC ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes Yes AP 2003/02/25 Prescription
007 BREVIBLOC ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML No No None 2003/05/28 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/08/14 SUPPL 48 Approval Manufacturing (CMC) PRIORITY
2015/01/26 SUPPL 47 Approval Manufacturing (CMC) PRIORITY
2014/03/20 SUPPL 46 Approval Manufacturing (CMC) PRIORITY
2013/08/13 SUPPL 41 Approval Manufacturing (CMC) PRIORITY
2012/12/11 SUPPL 43 Approval Labeling UNKNOWN
2007/11/06 SUPPL 39 Approval Labeling STANDARD
2003/08/18 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
2003/05/28 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
2003/02/25 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
2003/01/27 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
2003/01/27 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
2001/02/16 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
2001/01/26 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
2000/02/23 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
2000/01/19 SUPPL 16 Approval Labeling STANDARD
1995/10/04 SUPPL 13 Approval Labeling STANDARD
1994/01/13 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1993/11/24 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1993/07/01 SUPPL 10 Approval Labeling STANDARD
1992/12/18 SUPPL 8 Approval Efficacy
1992/12/18 SUPPL 3 Approval Efficacy
1991/10/21 SUPPL 9 Approval Labeling
1989/05/26 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1989/05/11 SUPPL 7 Approval Labeling
1988/08/15 SUPPL 6 Approval Labeling
1988/08/15 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1988/08/15 SUPPL 2 Approval Labeling
1988/08/15 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1986/12/31 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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
004 6310094 2021/01/12 PDF格式
6310094*PED 2021/07/12 PDF格式
6528540 2021/01/12 PDF格式
6528540*PED 2021/07/12 PDF格式
005 6310094 2021/01/12 PDF格式
6310094*PED 2021/07/12 PDF格式
6528540 2021/01/12 PDF格式
6528540*PED 2021/07/12 PDF格式
006 6310094 2021/01/12 PDF格式
6310094*PED 2021/07/12 PDF格式
6528540 2021/01/12 PDF格式
6528540*PED 2021/07/12 PDF格式
007 6310094 2021/01/12 PDF格式
6310094*PED 2021/07/12 PDF格式
6528540 2021/01/12 PDF格式
6528540*PED 2021/07/12 PDF格式
002 5017609 2008/05/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5017609*PED 2008/11/21 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5017609 2008/05/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5017609*PED 2008/11/21 PDF格式**本条是由Drugfuture回溯的历史信息**
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:10MG/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
019386 006 NDA BREVIBLOC ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 2003/02/25 BAXTER HLTHCARE
076323 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2004/08/10 WEST-WARD PHARMS INT
076474 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2005/05/02 MYLAN INSTITUTIONAL
076573 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2005/05/02 FRESENIUS KABI USA
205520 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2015/07/23 AUROBINDO PHARMA LTD
206608 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2018/06/08 MYLAN LABS LTD
207107 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2018/06/08 SAGENT PHARMS INC
208538 001 ANDA ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/08/14 GLAND PHARMA LTD
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