药品注册申请号：065397
申请类型：ANDA (仿制药申请)
申请人：MYLAN LABS LTD
申请人全名：MYLAN LABORATORIES LTD
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 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 2008/12/30 2008/12/30 Prescription
002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP 2008/12/30 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
2021/06/04 SUPPL-32（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-28（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-27（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-25（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-20（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-19（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-17（补充） Approval Labeling STANDARD
2020/08/19 SUPPL-16（补充） Approval Labeling STANDARD
2010/11/30 SUPPL-3（补充） Approval Manufacturing (CMC)
2009/06/23 SUPPL-2（补充） Approval Labeling
2009/05/29 SUPPL-1（补充） Approval Labeling
2008/12/30 ORIG-1（原始申请） Approval
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
无
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
无
与本品治疗等效的药品
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG BASE/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
062663 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP 1987/03/17 FRESENIUS KABI USA
062911 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP 1988/08/04 HOSPIRA
062931 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP 1992/10/29 HOSPIRA
065401 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Discontinued No No AP 2008/06/30 PHARM ASSOC
065397 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2008/12/30 MYLAN LABS LTD
090250 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Discontinued No No AP 2010/04/27 SANDOZ
204107 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2015/12/28 XELLIA PHARMS APS
205694 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2016/01/21 GLAND PHARMA LTD
205780 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2016/03/31 EUGIA PHARMA
212332 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2019/06/12 HAINAN POLY PHARM
213059 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Discontinued No No AP 2022/02/15 KNACK
216591 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2022/07/06 ASPIRO
215197 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2022/07/28 MEITHEAL
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/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
062663 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 1987/07/31 FRESENIUS KABI USA
062912 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 1988/08/04 HOSPIRA
062933 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 1992/10/29 HOSPIRA
065401 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2008/06/30 PHARM ASSOC
065397 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2008/12/30 MYLAN LABS LTD
090250 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2010/04/27 SANDOZ
204107 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2015/12/28 XELLIA PHARMS APS
205694 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2016/01/21 GLAND PHARMA LTD
205780 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2016/03/31 EUGIA PHARMA
212332 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2019/06/12 HAINAN POLY PHARM
203300 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2020/08/11 HIKMA
213059 003 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2022/02/15 KNACK
216591 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2022/07/06 ASPIRO
215197 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2022/07/28 MEITHEAL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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