药品注册申请号：200837
申请类型：ANDA (仿制药申请)
申请人：SAGENT PHARMS
申请人全名：SAGENT PHARMACEUTICALS 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 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL No No AP 2012/08/10 2012/08/10 Prescription
002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL No No AP 2014/09/02 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
2021/11/08 SUPPL-12（补充） Approval Labeling STANDARD
2020/09/02 SUPPL-8（补充） Approval Labeling STANDARD
2020/09/02 SUPPL-5（补充） Approval Labeling STANDARD
2012/08/10 ORIG-1（原始申请） Approval Not Applicable
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 5GM 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 003 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No Yes AP 1988/06/03 FRESENIUS KABI USA
063076 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No Yes AP 1990/12/21 HOSPIRA
065432 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2008/12/30 MYLAN LABS LTD
200837 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2012/08/10 SAGENT PHARMS
201048 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Discontinued No No AP 2012/08/10 SANDOZ INC
204125 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2015/12/28 XELLIA PHARMS APS
205779 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2016/03/29 EUGIA PHARMA
204360 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2018/10/15 HIKMA
215821 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2021/11/18 SLATE RUN PHARMA
215196 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2022/07/27 MEITHEAL
205694 003 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL Prescription No No AP 2023/06/06 GLAND PHARMA LTD
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 10GM 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 004 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No Yes AP 1997/11/28 FRESENIUS KABI USA
065455 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2009/04/29 HOSPIRA INC
091554 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No Yes AP 2011/09/19 MYLAN LABS LTD
201048 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Discontinued No No AP 2012/08/10 SANDOZ INC
200837 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2014/09/02 SAGENT PHARMS
204125 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2015/12/28 XELLIA PHARMS APS
205779 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2016/03/29 EUGIA PHARMA
204360 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2018/10/15 HIKMA
063076 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2020/09/14 HOSPIRA
215821 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2021/11/18 SLATE RUN PHARMA
215196 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2022/07/27 MEITHEAL
205694 004 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL Prescription No No AP 2023/06/06 GLAND PHARMA LTD
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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