药品注册申请号:020503
申请类型:NDA (新药申请)
申请人:3M DRUG DELIVERY
申请人全名:3M DRUG DELIVERY SYSTEMS
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 PROVENTIL-HFA ALBUTEROL SULFATE AEROSOL, METERED;INHALATION EQ 0.09MG BASE/INH Yes Yes BX 1996/08/15 1996/08/15 Prescription
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
2017/09/22 SUPPL 54 Approval Labeling STANDARD
2016/11/09 SUPPL 53 Approval Manufacturing (CMC) STANDARD
2016/03/03 SUPPL 51 Approval Manufacturing (CMC) STANDARD
2016/02/12 SUPPL 50 Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL 49 Approval Manufacturing (CMC) STANDARD
2013/02/25 SUPPL 47 Approval Manufacturing (CMC) STANDARD
2012/06/05 SUPPL 46 Approval Labeling UNKNOWN
2009/09/08 SUPPL 39 Approval Labeling STANDARD
2004/01/29 SUPPL 22 Approval Labeling STANDARD
2002/07/26 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2002/01/18 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2002/01/17 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2002/01/10 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2001/04/17 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2000/10/05 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2000/09/28 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/06/16 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2000/06/16 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2000/04/04 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2000/03/13 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1999/08/18 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1999/06/17 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1999/06/02 SUPPL 11 Approval Efficacy STANDARD
1998/09/23 SUPPL 4 Approval Efficacy STANDARD
1998/03/12 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1998/02/05 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1997/08/18 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1997/04/22 SUPPL 2 Approval Labeling STANDARD
1996/12/26 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/08/15 ORIG 1 Approval Type 3 - New Dosage Form 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
001 5225183 2010/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
5439670 2010/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
5605674 2014/02/25 PDF格式**本条是由Drugfuture回溯的历史信息**
5695743 2010/07/06 U-491 PDF格式**本条是由Drugfuture回溯的历史信息**
5766573 2015/06/16 PDF格式**本条是由Drugfuture回溯的历史信息**
5775321 2015/07/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6006745 2016/12/28 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6352684 2009/11/28 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:ALBUTEROL SULFATE 剂型/给药途径:AEROSOL, METERED;INHALATION 规格:EQ 0.09MG BASE/INH 治疗等效代码:BX
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
020503 001 NDA PROVENTIL-HFA ALBUTEROL SULFATE AEROSOL, METERED;INHALATION EQ 0.09MG BASE/INH Prescription Yes Yes BX 1996/08/15 3M DRUG DELIVERY
020983 001 NDA VENTOLIN HFA ALBUTEROL SULFATE AEROSOL, METERED;INHALATION EQ 0.09MG BASE/INH Prescription Yes Yes BX 2001/04/19 GLAXOSMITHKLINE
021457 001 NDA PROAIR HFA ALBUTEROL SULFATE AEROSOL, METERED;INHALATION EQ 0.09MG BASE/INH Prescription Yes Yes BX 2004/10/29 TEVA BRANDED PHARM
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