药品注册申请号:021912
申请类型:NDA (新药申请)
申请人:LUPIN
申请人全名:LUPIN INC
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 BROVANA ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Yes Yes AN 2006/10/06 2006/10/06 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
2019/05/29 SUPPL-32(补充) Approval Labeling STANDARD
2016/12/12 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
2016/07/11 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2015/11/06 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
2015/09/16 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2015/08/11 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2014/09/25 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2014/02/27 SUPPL-23(补充) Approval Efficacy STANDARD
2013/02/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2013/01/14 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2012/08/09 SUPPL-20(补充) Approval REMS N/A
2012/08/09 SUPPL-18(补充) Approval Supplement STANDARD
2011/09/02 SUPPL-16(补充) Approval Labeling UNKNOWN
2011/07/14 SUPPL-6(补充) Approval Labeling STANDARD
2011/02/16 SUPPL-15(补充) Approval Labeling UNKNOWN
2011/02/01 SUPPL-12(补充) Approval REMS N/A
2010/06/22 SUPPL-8(补充) Approval Labeling UNKNOWN
2010/06/02 SUPPL-11(补充) Approval Labeling 901 REQUIRED
2007/12/20 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
2006/10/06 ORIG-1(原始申请) 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 5795564 2012/04/03 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
6040344 2016/11/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6068833 2012/04/03 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
6472563 2021/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6589508 2012/04/03 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
6589508 2014/04/03 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
6667344 2021/06/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6720453 2021/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6814953 2021/06/22 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
6866839 2012/04/03 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
7145036 2021/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7348362 2021/06/22 Y U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
7462645 2021/06/22 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
7465756 2021/06/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7473710 2021/06/22 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
7541385 2021/06/22 U-793 PDF格式**本条是由Drugfuture回溯的历史信息**
8110706 2021/11/09 Y 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
001 NP 2009/10/06**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:ARFORMOTEROL TARTRATE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.015MG BASE/2ML 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
021912 001 NDA BROVANA ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription Yes Yes AN 2006/10/06 LUPIN
207306 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2021/06/22 CIPLA
213132 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Discontinued No No AN 2021/06/22 GLENMARK PHARMS LTD
213762 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2021/06/22 SLATE RUN PHARMA
200293 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2021/11/09 TEVA PHARMS USA
213068 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/02/07 LUPIN
214736 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/03/02 RITEDOSE CORP
214779 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/05/10 ALEMBIC
215385 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/05/26 SUN PHARM
216128 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/11/15 MANKIND PHARMA
216815 001 ANDA ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE SOLUTION;INHALATION EQ 0.015MG BASE/2ML Prescription No No AN 2022/11/25 SLAYBACK PHARMA LLC
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