药品注册申请号：020837
申请类型：NDA (新药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AN 1999/03/25 1999/03/25 Discontinued
002 XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AN 1999/03/25 Discontinued
003 XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AN 2002/01/30 Discontinued
004 XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AN 2003/07/18 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1999/03/25 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/01/03 SUPPL-44（补充） Approval Labeling-Package Insert STANDARD
2015/03/31 SUPPL-43（补充） Approval Labeling-Package Insert STANDARD
2015/01/22 SUPPL-41（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2014/12/15 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
2014/03/31 SUPPL-39（补充） Approval Labeling-Package Insert STANDARD
2014/01/15 SUPPL-40（补充） Approval Labeling-Container/Carton Labels STANDARD
2013/09/20 SUPPL-38（补充） Approval Labeling-Package Insert STANDARD
2013/01/09 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
2013/01/09 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
2012/09/07 SUPPL-36（补充） Approval Labeling-Package Insert UNKNOWN
2006/09/07 SUPPL-20（补充） Approval Labeling STANDARD
2003/07/18 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/08/07 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/03/04 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2002/01/30 SUPPL-6（补充） Approval Efficacy-New Patient Population STANDARD
2001/02/16 SUPPL-5（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2000/12/04 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/04/12 SUPPL-3（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/09/21 SUPPL-1（补充） Approval Manufacturing (CMC) 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 5362755 2011/11/08 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5362755 2013/03/25 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5547994 2013/08/20 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5760090 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5844002 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6083993 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6451289 2021/03/21 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5362755 2011/11/08 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5362755 2013/03/25 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5547994 2013/08/20 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5760090 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5844002 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6083993 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6451289 2021/03/21 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5362755 2011/11/08 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5362755 2013/03/25 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5547994 2013/08/20 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5760090 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5844002 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6083993 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6451289 2021/03/21 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5362755 2011/11/08 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5362755 2013/03/25 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5547994 2013/08/20 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5760090 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
5844002 2010/01/05 U-5 PDF格式**本条是由Drugfuture回溯的历史信息**
6083993 2010/01/05 U-332 PDF格式**本条是由Drugfuture回溯的历史信息**
6451289 2021/03/21 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 M-151 2018/01/22**本条是由Drugfuture回溯的历史信息**
002 M-151 2018/01/22**本条是由Drugfuture回溯的历史信息**
003 M-151 2018/01/22**本条是由Drugfuture回溯的历史信息**
004 M-151 2018/01/22**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:LEVALBUTEROL HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INHALATION; 规格:EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020837 001 NDA XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AN 1999/03/25 HIKMA
>>>活性成分:LEVALBUTEROL HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INHALATION; 规格:EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020837 002 NDA XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AN 1999/03/25 HIKMA
>>>活性成分:LEVALBUTEROL HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INHALATION; 规格:EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020837 003 NDA XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AN 2002/01/30 HIKMA
>>>活性成分:LEVALBUTEROL HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INHALATION; 规格:EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
020837 004 NDA XOPENEX LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AN 2003/07/18 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database