药品注册申请号:206398
申请类型:ANDA (仿制药申请)
申请人:ALMAJECT
申请人全名:ALMAJECT 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 VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL No No AP 2016/03/23 2016/03/23 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
2023/02/02 SUPPL-7(补充) Approval Labeling STANDARD
2023/02/02 SUPPL-6(补充) Approval Labeling STANDARD
2021/07/02 SUPPL-5(补充) Approval Labeling STANDARD
2021/07/02 SUPPL-1(补充) Approval Labeling STANDARD
2016/03/23 ORIG-1(原始申请) Approval 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
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
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 ALMAJECT
208562 001 NDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2017/03/09 XELLIA PHARMS APS
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 SLATE RUN PHARMA
211099 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2020/03/31 GLAND PHARMA LTD
214516 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2022/05/09 MEITHEAL
210849 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Discontinued No No AP 2022/10/11 MYLAN LABS LTD
212162 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Discontinued No No AP 2023/02/02 EUGIA PHARMA
211264 001 ANDA VORICONAZOLE VORICONAZOLE INJECTABLE;INTRAVENOUS 200MG/VIAL Prescription No No AP 2023/03/09 UBI
更多信息
药品NDC数据与药品包装、标签说明书
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