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)
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 | RLD | RS | TE 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 | RLD | RS | TE 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 |