药品注册申请号:020949
申请类型:NDA (新药申请)
申请人:MYLAN SPECIALITY LP
申请人全名:MYLAN SPECIALTY LP
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 ACCUNEB ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.042% BASE Yes Yes AN 2001/04/30 2001/04/30 Prescription
002 ACCUNEB ALBUTEROL SULFATE SOLUTION;INHALATION EQ 0.021% BASE Yes Yes AN 2001/04/30 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
2013/09/30 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2013/09/30 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2011/03/02 SUPPL 24 Approval Labeling UNKNOWN
2006/06/02 SUPPL 11 Approval Labeling STANDARD
2002/11/13 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2002/08/06 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2002/02/20 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2002/02/20 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2002/01/22 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2002/01/22 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2001/04/30 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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 6702997 2021/12/28 U-558 PDF格式
002 6702997 2021/12/28 U-558 PDF格式
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
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
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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药品NDC数据与药品包装、标签说明书
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