药品注册申请号:021131
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 SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Yes No AP 2000/04/18 2000/04/18 Prescription
002 ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/04/18 Discontinued
003 ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Yes Yes AP 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
2024/06/27 SUPPL-44(补充) Approval Labeling STANDARD
2023/07/18 SUPPL-41(补充) Approval Labeling STANDARD
2021/11/10 SUPPL-40(补充) Approval Labeling STANDARD
2021/10/26 SUPPL-39(补充) Approval Labeling STANDARD
2021/09/01 SUPPL-38(补充) Approval Labeling STANDARD
2021/07/16 SUPPL-37(补充) Approval Labeling STANDARD
2020/08/05 SUPPL-35(补充) Approval Labeling STANDARD
2020/08/05 SUPPL-34(补充) Approval Labeling STANDARD
2018/02/01 SUPPL-30(补充) Approval Labeling STANDARD
2017/07/13 SUPPL-28(补充) Approval Labeling STANDARD
2015/06/05 SUPPL-29(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-27(补充) Approval Manufacturing (CMC) PRIORITY
2014/01/24 SUPPL-26(补充) Approval Labeling STANDARD
2013/05/03 SUPPL-22(补充) Approval Labeling STANDARD
2013/05/03 SUPPL-21(补充) Approval Labeling STANDARD
2012/02/13 SUPPL-24(补充) Approval Labeling STANDARD
2010/07/16 SUPPL-20(补充) Approval Labeling UNKNOWN
2009/12/08 SUPPL-17(补充) Approval Labeling STANDARD
2008/06/20 SUPPL-14(补充) Approval Labeling STANDARD
2008/06/20 SUPPL-13(补充) Approval Labeling STANDARD
2007/09/18 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
2007/08/02 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2007/04/26 SUPPL-12(补充) Approval Labeling STANDARD
2005/11/02 SUPPL-11(补充) Approval Labeling STANDARD
2005/05/12 SUPPL-10(补充) Approval Efficacy PRIORITY
2005/05/12 SUPPL-9(补充) Approval Labeling STANDARD
2005/02/10 SUPPL-8(补充) Approval Labeling STANDARD
2004/06/23 SUPPL-7(补充) Approval Efficacy PRIORITY
2004/01/05 SUPPL-6(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 3 - New Dosage Form 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 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**
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 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**
003 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**
与本品治疗等效的药品
活性成分:LINEZOLID 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:200MG/100ML (2MG/ML) 治疗等效代码:AP
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
021131 001 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription Yes No AP 2000/04/18 PFIZER
200904 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
207354 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) Prescription No No AP 2017/12/06 MYLAN LABS LTD
活性成分:LINEZOLID 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:600MG/300ML (2MG/ML) 治疗等效代码:AP
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
021131 003 NDA ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription Yes Yes AP 2000/04/18 PFIZER
200222 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Discontinued No No AP 2012/06/27 TEVA PHARMS
200904 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2015/07/16 SANDOZ
204764 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/03/15 FRESENIUS KABI USA
206917 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/08/04 EUGIA PHARMA
207354 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2016/12/20 NANG KUANG PHARM CO
204696 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/03/02 SAGENT PHARMS INC
207001 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/07/07 HQ SPCLT PHARMA
205154 002 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2017/12/06 MYLAN LABS LTD
206454 001 ANDA LINEZOLID LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) Prescription No No AP 2022/08/22 HIKMA
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