药品注册申请号:021861
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS 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 PATANASE OLOPATADINE HYDROCHLORIDE SPRAY, METERED;NASAL 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2008/04/15 2008/04/15 Discontinued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
2008/04/15 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
2021/03/04 SUPPL-15(补充) Approval Labeling-Package Insert STANDARD
2016/07/27 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2015/10/27 SUPPL-11(补充) Approval Labeling-Package Insert STANDARD
2012/02/22 SUPPL-9(补充) Approval Labeling-Package Insert STANDARD
2010/03/31 SUPPL-8(补充) Approval Efficacy-Labeling Change With Clinical Data STANDARD
2009/12/01 SUPPL-2(补充) Approval Efficacy-New Patient Population PRIORITY
2009/06/17 SUPPL-1(补充) Approval Efficacy-Labeling Change With Clinical Data UNKNOWN
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 5116863 2010/12/18 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
7977376 2023/02/02 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7977376*PED 2023/08/02 PDF格式**本条是由Drugfuture回溯的历史信息**
8399508 2022/09/17 U-726 PDF格式**本条是由Drugfuture回溯的历史信息**
8399508*PED 2023/03/17 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 NDF 2011/04/15**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:OLOPATADINE HYDROCHLORIDE; 剂型/给药途径:SPRAY, METERED;NASAL; 规格:0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<
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
021861 001 NDA PATANASE OLOPATADINE HYDROCHLORIDE SPRAY, METERED;NASAL 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2008/04/15 NOVARTIS
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药品NDC数据与药品包装、标签说明书
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