药品注册申请号:021130
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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001 ZYVOX LINEZOLID TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/04/18 2000/04/18 Discontinued
002 ZYVOX LINEZOLID TABLET;ORAL 600MG Yes Yes AB 2000/04/18 Prescription
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
2023/07/18 SUPPL-44(补充) Approval Labeling STANDARD
2021/10/26 SUPPL-43(补充) Approval Labeling STANDARD
2021/09/01 SUPPL-42(补充) Approval Labeling STANDARD
2021/07/16 SUPPL-41(补充) Approval Labeling STANDARD
2020/08/05 SUPPL-40(补充) Approval Labeling STANDARD
2020/08/05 SUPPL-39(补充) Approval Labeling STANDARD
2018/02/01 SUPPL-37(补充) Approval Labeling STANDARD
2017/07/13 SUPPL-34(补充) Approval Labeling STANDARD
2015/06/05 SUPPL-35(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2014/07/28 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
2014/01/24 SUPPL-32(补充) Approval Labeling STANDARD
2013/05/03 SUPPL-24(补充) Approval Labeling STANDARD
2013/05/03 SUPPL-23(补充) Approval Labeling STANDARD
2012/02/13 SUPPL-28(补充) Approval Labeling STANDARD
2010/07/16 SUPPL-22(补充) Approval Labeling STANDARD
2009/12/08 SUPPL-20(补充) Approval Labeling STANDARD
2008/06/20 SUPPL-17(补充) Approval Labeling STANDARD
2008/06/20 SUPPL-16(补充) Approval Labeling STANDARD
2008/02/19 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
2007/09/18 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
2007/06/08 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2007/04/26 SUPPL-12(补充) Approval Labeling STANDARD
2007/03/26 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
2007/03/21 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2005/11/02 SUPPL-10(补充) Approval Labeling STANDARD
2005/05/12 SUPPL-9(补充) Approval Efficacy PRIORITY
2005/05/12 SUPPL-8(补充) Approval Labeling STANDARD
2005/02/10 SUPPL-7(补充) Approval Labeling STANDARD
2004/06/23 SUPPL-6(补充) Approval Efficacy PRIORITY
2004/01/05 SUPPL-5(补充) Approval Labeling STANDARD
2003/07/22 SUPPL-4(补充) Approval Efficacy STANDARD
2002/12/19 SUPPL-3(补充) Approval Efficacy PRIORITY
2002/12/19 SUPPL-2(补充) Approval Labeling STANDARD
2001/02/06 SUPPL-1(补充) Approval Labeling STANDARD
2000/04/18 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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 5688792 2014/11/18 Y U-319 PDF格式**本条是由Drugfuture回溯的历史信息**
5688792*PED 2015/05/18 PDF格式**本条是由Drugfuture回溯的历史信息**
6514529 2021/03/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6514529*PED 2021/09/15 PDF格式**本条是由Drugfuture回溯的历史信息**
6559305 2021/01/29 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6559305*PED 2021/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5688792 2014/11/18 Y U-319 PDF格式**本条是由Drugfuture回溯的历史信息**
5688792*PED 2015/05/18 PDF格式**本条是由Drugfuture回溯的历史信息**
6514529 2021/03/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6514529*PED 2021/09/15 PDF格式**本条是由Drugfuture回溯的历史信息**
6559305 2021/01/29 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6559305*PED 2021/07/29 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 I-402 2006/07/22**本条是由Drugfuture回溯的历史信息**
I-431 2007/06/23**本条是由Drugfuture回溯的历史信息**
PED 2007/01/22**本条是由Drugfuture回溯的历史信息**
PED 2007/12/23**本条是由Drugfuture回溯的历史信息**
002 I-402 2006/07/22**本条是由Drugfuture回溯的历史信息**
I-431 2007/06/23**本条是由Drugfuture回溯的历史信息**
PED 2007/01/22**本条是由Drugfuture回溯的历史信息**
PED 2007/12/23**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:LINEZOLID 剂型/给药途径:TABLET;ORAL 规格:600MG 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
021130 002 NDA ZYVOX LINEZOLID TABLET;ORAL 600MG Prescription Yes Yes AB 2000/04/18 PFIZER
078845 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2015/12/21 RISING
078987 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2015/12/21 GLENMARK PHARMS
204239 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2015/12/21 HETERO LABS LTD V
204536 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Discontinued No No AB 2015/12/21 AMNEAL PHARMS
205233 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2015/12/21 ALEMBIC
205517 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2015/12/21 ALKEM LABS LTD
207526 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2016/08/22 NOVEL LABS INC
206097 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2017/02/22 ZYDUS PHARMS
210702 001 ANDA LINEZOLID LINEZOLID TABLET;ORAL 600MG Prescription No No AB 2019/04/25 CHARTWELL RX
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database