药品注册申请号:020605
申请类型:NDA (新药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 ZOFRAN ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Yes No AA 1997/01/24 1997/01/24 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
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
2021/10/20 SUPPL-22(补充) Approval Labeling STANDARD
2021/04/29 SUPPL-21(补充) Approval Labeling STANDARD
2017/10/05 SUPPL-20(补充) Approval Labeling STANDARD
2016/11/09 SUPPL-19(补充) Approval Labeling STANDARD
2016/09/28 SUPPL-17(补充) Approval Labeling STANDARD
2014/09/18 SUPPL-18(补充) Approval Labeling 901 REQUIRED
2013/12/10 SUPPL-15(补充) Approval Labeling STANDARD
2011/09/14 SUPPL-14(补充) Approval Labeling STANDARD
2010/09/22 SUPPL-13(补充) Approval Labeling UNKNOWN
2006/08/22 SUPPL-10(补充) Approval Labeling STANDARD
2005/12/27 SUPPL-8(补充) Approval Labeling STANDARD
2004/11/24 SUPPL-7(补充) Approval Labeling STANDARD
2000/12/13 SUPPL-5(补充) Approval Labeling STANDARD
2000/04/11 SUPPL-4(补充) Approval Labeling STANDARD
1999/01/26 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1997/04/15 SUPPL-1(补充) Approval Labeling STANDARD
1997/01/24 ORIG-1(原始申请) 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 4753789*PED 2006/12/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5854270 2015/11/20 Y U-44 PDF格式**本条是由Drugfuture回溯的历史信息**
5854270*PED 2016/05/20 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
与本品治疗等效的药品
活性成分:ONDANSETRON HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:EQ 4MG BASE/5ML 治疗等效代码:AA
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
020605 001 NDA ZOFRAN ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Discontinued Yes No AA 1997/01/24 SANDOZ
076960 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Prescription No Yes AA 2006/12/26 HIKMA
078127 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Discontinued No No AA 2007/06/25 PHARM ASSOC
078776 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Prescription No No AA 2007/11/28 AUROBINDO PHARMA
077009 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Prescription No No AA 2007/11/30 TARO
091342 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Prescription No No AA 2011/01/27 CHARTWELL MOLECULAR
091483 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION;ORAL EQ 4MG BASE/5ML Prescription No No AA 2011/01/31 AMNEAL PHARMS
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