药品注册申请号:076355
申请类型:ANDA (仿制药申请)
申请人:NEPHRON
申请人全名:NEPHRON PHARMACEUTICALS CORP
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 ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE No No AN 2004/06/28 2004/06/28 Prescription
002 ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE No No AN 2010/03/31 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
2011/09/13 SUPPL 12 Approval Labeling
2010/03/31 SUPPL 7 Approval Labeling
2007/03/29 SUPPL 4 Approval Labeling
2005/03/22 SUPPL 1 Approval Labeling
2004/06/28 ORIG 1 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:ALBUTEROL SULFATE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.042% BASE 治疗等效代码:AN
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
211888 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE Prescription No AN -- AUROBINDO PHARMA LTD
020949 001 NDA ACCUNEB ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE Prescription Yes Yes AN 2001/04/30 MYLAN SPECIALITY LP
076355 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE Prescription No No AN 2004/06/28 NEPHRON
077772 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE Prescription No No AN 2007/09/25 WATSON LABS
活性成分:ALBUTEROL SULFATE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.021% BASE 治疗等效代码:AN
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
211888 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE Prescription No AN -- AUROBINDO PHARMA LTD
020949 002 NDA ACCUNEB ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE Prescription Yes Yes AN 2001/04/30 MYLAN SPECIALITY LP
077772 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE Prescription No No AN 2007/09/25 WATSON LABS
076355 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE Prescription No No AN 2010/03/31 NEPHRON
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