药品注册申请号:021267
申请类型:NDA (新药申请)
申请人:PF PRISM CV
申请人全名:PF PRISM CV
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 VFEND VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Yes Yes AP 2002/05/24 2002/05/24 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
2019/04/30 SUPPL 55 Approval Labeling STANDARD
2019/01/29 SUPPL 50 Approval Efficacy PRIORITY
2017/07/28 SUPPL 54 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/06/15 SUPPL 53 Approval Labeling STANDARD
2016/01/15 SUPPL 48 Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL 47 Approval Labeling STANDARD
2014/06/24 SUPPL 46 Approval Manufacturing (CMC) STANDARD
2014/06/09 SUPPL 45 Approval Manufacturing (CMC) STANDARD
2014/04/07 SUPPL 44 Approval Labeling STANDARD
2013/07/25 SUPPL 42 Approval Manufacturing (CMC) STANDARD
2011/11/16 SUPPL 40 Approval Labeling STANDARD
2011/06/01 SUPPL 37 Approval Labeling UNKNOWN
2010/12/15 SUPPL 34 Approval Labeling UNKNOWN
2010/11/21 SUPPL 36 Approval Labeling UNKNOWN
2010/06/17 SUPPL 33 Approval Labeling UNKNOWN
2010/06/17 SUPPL 32 Approval Labeling UNKNOWN
2010/06/17 SUPPL 29 Approval Labeling STANDARD
2010/06/17 SUPPL 25 Approval Labeling STANDARD
2008/05/30 SUPPL 26 Approval Labeling STANDARD
2008/03/10 SUPPL 24 Approval Labeling STANDARD
2008/02/05 SUPPL 16 Approval Labeling STANDARD
2006/12/01 SUPPL 21 Approval Labeling STANDARD
2006/05/19 SUPPL 19 Approval Labeling STANDARD
2006/03/10 SUPPL 15 Approval Labeling STANDARD
2005/12/18 SUPPL 12 Approval Labeling STANDARD
2005/07/07 SUPPL 11 Approval Labeling STANDARD
2005/03/24 SUPPL 10 Approval Labeling STANDARD
2004/12/21 SUPPL 9 Approval Efficacy STANDARD
2004/04/21 SUPPL 6 Approval Labeling STANDARD
2004/04/21 SUPPL 5 Approval Labeling STANDARD
2004/02/04 SUPPL 7 Approval Labeling STANDARD
2003/03/28 SUPPL 3 Approval Labeling STANDARD
2002/05/24 ORIG 1 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 5116844 2009/08/11 Y U-540 PDF格式**本条是由Drugfuture回溯的历史信息**
5134127 2010/01/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5364938 2011/11/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5376645 2010/01/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5567817 2016/05/24 Y Y U-540 PDF格式**本条是由Drugfuture回溯的历史信息**
5773443 2011/01/25 Y Y U-540 PDF格式**本条是由Drugfuture回溯的历史信息**
6632803 2018/06/02 Y 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 NPP 2022/01/29
001 I-409 2006/11/14**本条是由Drugfuture回溯的历史信息**
I-442 2007/12/21**本条是由Drugfuture回溯的历史信息**
NCE 2007/05/24**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:VORICONAZOLE 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:200MG/VIAL 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
021267 001 NDA VFEND VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription Yes Yes AP 2002/05/24 PF PRISM CV
090862 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2012/05/30 SANDOZ INC
206398 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2016/03/23 ALVOGEN
208983 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2018/07/16 ZYDUS PHARMS
211661 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2018/11/30 HAINAN POLY PHARM
211099 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2020/03/31 GLAND PHARMA LTD
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