药品注册申请号:021266
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 TABLET;ORAL 50MG Yes No AB 2002/05/24 2002/05/24 Prescription
002 VFEND VORICONAZOLE TABLET;ORAL 200MG Yes Yes AB 2002/05/24 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
2022/10/18 SUPPL-53(补充) Approval Labeling STANDARD
2022/08/16 SUPPL-54(补充) Approval Labeling STANDARD
2022/01/28 SUPPL-52(补充) Approval Labeling STANDARD
2021/10/13 SUPPL-51(补充) Approval Labeling STANDARD
2021/04/15 SUPPL-50(补充) Approval Labeling STANDARD
2021/01/25 SUPPL-49(补充) Approval Labeling STANDARD
2021/01/14 SUPPL-47(补充) Approval Labeling STANDARD
2020/09/04 SUPPL-48(补充) Approval Labeling STANDARD
2019/04/30 SUPPL-45(补充) Approval Labeling STANDARD
2019/01/29 SUPPL-39(补充) Approval Efficacy PRIORITY
2017/07/28 SUPPL-43(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.
2017/06/15 SUPPL-41(补充) Approval Labeling STANDARD
2015/02/03 SUPPL-38(补充) Approval Labeling STANDARD
2014/04/07 SUPPL-37(补充) Approval Labeling STANDARD
2013/03/01 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
2011/11/16 SUPPL-35(补充) Approval Labeling STANDARD
2011/06/01 SUPPL-33(补充) Approval Labeling UNKNOWN
2010/12/15 SUPPL-34(补充) Approval Labeling STANDARD
2010/12/15 SUPPL-31(补充) Approval Labeling UNKNOWN
2010/12/15 SUPPL-22(补充) Approval Labeling STANDARD
2010/11/21 SUPPL-32(补充) Approval Labeling UNKNOWN
2010/06/17 SUPPL-30(补充) Approval Labeling UNKNOWN
2010/06/17 SUPPL-29(补充) Approval Labeling UNKNOWN
2010/06/17 SUPPL-27(补充) Approval Labeling STANDARD
2010/06/17 SUPPL-25(补充) Approval Labeling STANDARD
2008/05/30 SUPPL-26(补充) Approval Labeling STANDARD
2008/03/10 SUPPL-23(补充) Approval Labeling STANDARD
2008/02/05 SUPPL-16(补充) Approval Labeling STANDARD
2006/12/01 SUPPL-19(补充) Approval Labeling STANDARD
2006/05/19 SUPPL-18(补充) Approval Labeling STANDARD
2006/03/10 SUPPL-15(补充) Approval Labeling STANDARD
2005/12/18 SUPPL-13(补充) Approval Labeling STANDARD
2005/07/07 SUPPL-12(补充) Approval Labeling STANDARD
2005/03/24 SUPPL-10(补充) Approval Labeling STANDARD
2004/12/21 SUPPL-9(补充) Approval Efficacy STANDARD
2004/04/21 SUPPL-6(补充) Approval Labeling STANDARD
2004/04/21 SUPPL-5(补充) Approval Labeling STANDARD
2004/02/04 SUPPL-7(补充) Approval Labeling STANDARD
2003/03/28 SUPPL-2(补充) Approval Labeling STANDARD
2002/05/24 ORIG-1(原始申请) 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 5116844 2009/08/11 Y U-540 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**
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**
002 5116844 2009/08/11 Y U-540 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**
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**
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-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**
NPP 2022/01/29**本条是由Drugfuture回溯的历史信息**
002 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**
NPP 2022/01/29**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:TABLET;ORAL 规格:50MG 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
021266 001 NDA VFEND VORICONAZOLE TABLET;ORAL 50MG Prescription Yes No AB 2002/05/24 PF PRISM CV
090547 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2010/04/22 MYLAN PHARMS INC
200265 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2011/12/12 SANDOZ INC
203503 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2015/09/02 GLENMARK PHARMS LTD
206837 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/01/22 AUROBINDO PHARMA LTD
206747 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/05/24 CADILA
206762 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/05/24 RISING
206181 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/05/24 AJANTA PHARMA LTD
207371 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/05/24 CHARTWELL RX
206654 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/08/08 PRINSTON INC
207049 001 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 50MG Prescription No No AB 2016/09/07 EPIC PHARMA LLC
活性成分:VORICONAZOLE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
021266 002 NDA VFEND VORICONAZOLE TABLET;ORAL 200MG Prescription Yes Yes AB 2002/05/24 PF PRISM CV
090547 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2010/04/22 MYLAN PHARMS INC
200265 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2011/12/12 SANDOZ INC
203503 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2015/09/02 GLENMARK PHARMS LTD
206837 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/01/22 AUROBINDO PHARMA LTD
206747 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/05/24 CADILA
206762 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/05/24 RISING
206181 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/05/24 AJANTA PHARMA LTD
207371 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/05/24 CHARTWELL RX
206654 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/08/08 PRINSTON INC
207049 002 ANDA VORICONAZOLE VORICONAZOLE TABLET;ORAL 200MG Prescription No No AB 2016/09/07 EPIC PHARMA LLC
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