药品注册申请号:020031
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 TABLET;ORAL EQ 10MG BASE Yes No AB 1992/12/29 1992/12/29 Prescription
002 PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Yes No AB 1992/12/29 Prescription
003 PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Yes No AB 1992/12/29 Prescription
004 PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No None 1992/12/29 Discontinued
005 PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Yes Yes AB 1992/12/29 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 74 Approval Labeling 901 REQUIRED
2014/07/18 SUPPL 71 Approval Labeling 901 REQUIRED
2012/12/18 SUPPL 67 Approval Labeling STANDARD
2012/04/10 SUPPL 68 Approval Labeling STANDARD
2011/07/08 SUPPL 66 Approval Labeling STANDARD
2011/07/08 SUPPL 58 Approval Labeling STANDARD
2011/03/21 SUPPL 69 Approval Labeling STANDARD
2011/03/21 SUPPL 65 Approval Labeling UNKNOWN
2011/03/21 SUPPL 62 Approval Labeling STANDARD
2010/10/27 SUPPL 63 Approval Labeling STANDARD
2009/08/07 SUPPL 59 Approval Labeling STANDARD
2009/01/30 SUPPL 61 Approval Labeling STANDARD
2008/10/31 SUPPL 60 Approval Labeling STANDARD
2007/08/02 SUPPL 53 Approval Labeling STANDARD
2006/08/22 SUPPL 55 Approval Labeling STANDARD
2006/08/22 SUPPL 54 Approval Labeling STANDARD
2006/08/22 SUPPL 49 Approval Labeling STANDARD
2006/03/09 SUPPL 46 Approval Labeling STANDARD
2006/02/06 SUPPL 52 Approval Labeling STANDARD
2006/02/06 SUPPL 51 Approval Labeling STANDARD
2006/02/06 SUPPL 48 Approval Labeling STANDARD
2005/07/13 SUPPL 42 Approval Labeling STANDARD
2005/01/12 SUPPL 45 Approval Labeling STANDARD
2004/05/21 SUPPL 43 Approval Labeling STANDARD
2004/04/08 SUPPL 40 Approval Labeling STANDARD
2004/04/08 SUPPL 39 Approval Labeling STANDARD
2002/10/02 SUPPL 35 Approval Efficacy STANDARD
2001/12/14 SUPPL 29 Approval Efficacy STANDARD
2001/05/22 SUPPL 33 Approval Manufacturing (CMC) STANDARD
2001/04/30 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2001/04/30 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2001/04/13 SUPPL 26 Approval Efficacy STANDARD
2001/02/15 SUPPL 31 Approval Labeling STANDARD
2000/09/28 SUPPL 30 Approval Labeling STANDARD
2000/09/21 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2000/09/20 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2000/05/17 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1999/05/11 SUPPL 23 Approval Efficacy STANDARD
1998/02/19 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1998/02/19 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1997/12/16 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1997/07/22 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1997/07/14 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1997/06/24 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1997/05/19 SUPPL 17 Approval Labeling STANDARD
1996/12/13 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1996/10/17 SUPPL 15 Approval Labeling STANDARD
1996/07/11 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1996/07/02 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1996/05/07 SUPPL 9 Approval Efficacy STANDARD
1996/05/07 SUPPL 7 Approval Efficacy STANDARD
1996/03/05 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1995/05/10 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1995/02/23 SUPPL 8 Approval Labeling STANDARD
1995/02/23 SUPPL 5 Approval Labeling STANDARD
1995/02/23 SUPPL 3 Approval Labeling STANDARD
1994/11/29 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1994/09/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1994/06/22 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1992/12/29 ORIG 1 Approval Type 1 - New Molecular Entity 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 U-12 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 U-12 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**
6113944 2014/12/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6113944*PED 2015/06/14 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**
002 4721723 2006/12/29 U-12 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 U-12 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**
6113944 2014/12/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6113944*PED 2015/06/14 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**
003 4721723 2006/12/29 U-12 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 U-12 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**
6113944 2014/12/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6113944*PED 2015/06/14 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**
004 4721723 2006/12/29 U-12 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 U-12 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**
6113944 2014/12/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6113944*PED 2015/06/14 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**
005 4721723 2006/12/29 U-12 PDF格式**本条是由Drugfuture回溯的历史信息**
4721723*PED 2007/06/29 U-12 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**
6113944 2014/12/14 PDF格式**本条是由Drugfuture回溯的历史信息**
6113944*PED 2015/06/14 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
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 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
020031 001 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 1992/12/29 APOTEX TECHNOLOGIES
075356 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2005/08/15 TEVA
077584 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078194 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/06/29 SUN PHARM INDS INC
078406 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 001 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
205528 001 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/11/27 JUBILANT GENERICS
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG BASE 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
020031 002 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription Yes No AB 1992/12/29 APOTEX TECHNOLOGIES
075356 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2005/08/15 TEVA
077584 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078194 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/06/29 SUN PHARM INDS INC
078406 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 002 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
205528 002 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2015/11/27 JUBILANT GENERICS
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 30MG BASE 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
020031 003 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription Yes No AB 1992/12/29 APOTEX TECHNOLOGIES
075356 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2005/08/15 TEVA
077584 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078194 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2007/06/29 SUN PHARM INDS INC
078406 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 003 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
205528 003 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2015/11/27 JUBILANT GENERICS
活性成分:PAROXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 40MG BASE 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
020031 005 NDA PAXIL PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription Yes Yes AB 1992/12/29 APOTEX TECHNOLOGIES
075356 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2003/07/30 APOTEX
076618 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2005/08/15 TEVA
077584 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/03/07 ZYDUS PHARMS USA
078194 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/06/29 SUN PHARM INDS INC
078406 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/07/25 AUROBINDO PHARMA
078902 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2008/03/13 MYLAN
076968 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2010/06/21 OXFORD PHARMS
203854 004 ANDA PAROXETINE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2014/10/31 PRINSTON INC
205528 004 ANDA PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2015/11/27 JUBILANT GENERICS
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