药品注册申请号:020710
申请类型:NDA (新药申请)
申请人:APOTEX TECHNOLOGIES
申请人全名:APOTEX TECHNOLOGIES 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 PAXIL PAROXETINE HYDROCHLORIDE SUSPENSION;ORAL EQ 10MG BASE/5ML Yes Yes None 1997/06/25 1997/06/25 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
2017/01/04 SUPPL 38 Approval Labeling 901 REQUIRED
2014/07/18 SUPPL 35 Approval Labeling 901 REQUIRED
2012/12/18 SUPPL 31 Approval Labeling STANDARD
2012/04/10 SUPPL 32 Approval Labeling STANDARD
2011/07/08 SUPPL 30 Approval Labeling STANDARD
2011/07/08 SUPPL 22 Approval Labeling STANDARD
2011/03/21 SUPPL 33 Approval Labeling STANDARD
2011/03/21 SUPPL 29 Approval Labeling UNKNOWN
2011/03/21 SUPPL 26 Approval Labeling STANDARD
2010/10/27 SUPPL 27 Approval Labeling STANDARD
2009/08/07 SUPPL 23 Approval Labeling STANDARD
2009/01/30 SUPPL 25 Approval Labeling STANDARD
2008/10/31 SUPPL 24 Approval Labeling STANDARD
2007/08/02 SUPPL 17 Approval Labeling STANDARD
2006/08/22 SUPPL 19 Approval Labeling STANDARD
2006/08/22 SUPPL 18 Approval Labeling STANDARD
2006/02/06 SUPPL 16 Approval Labeling STANDARD
2006/02/06 SUPPL 15 Approval Labeling STANDARD
2001/11/08 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2001/04/30 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2001/04/30 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2001/02/15 SUPPL 9 Approval Labeling STANDARD
2000/09/28 SUPPL 8 Approval Labeling STANDARD
2000/09/21 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2000/07/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2000/06/27 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/02/23 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1998/02/20 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1997/11/06 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/06/25 ORIG 1 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 4721723 2006/12/29 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 PDF格式**本条是由Drugfuture回溯的历史信息**
5789449 2009/01/06 U-285 PDF格式**本条是由Drugfuture回溯的历史信息**
5789449*PED 2009/07/06 U-285 PDF格式**本条是由Drugfuture回溯的历史信息**
5811436 2015/09/22 PDF格式**本条是由Drugfuture回溯的历史信息**
5811436*PED 2016/03/22 PDF格式**本条是由Drugfuture回溯的历史信息**
5872132 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5872132*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5900423 2015/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
5900423*PED 2015/11/19 PDF格式**本条是由Drugfuture回溯的历史信息**
6121291 2017/03/17 U-286 U-431 PDF格式**本条是由Drugfuture回溯的历史信息**
6121291*PED 2017/09/17 U-286 U-431 PDF格式**本条是由Drugfuture回溯的历史信息**
6133289 2015/05/19 U-358 PDF格式**本条是由Drugfuture回溯的历史信息**
6133289*PED 2015/11/19 U-358 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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database