药品注册申请号：062663
申请类型：ANDA (仿制药申请)
申请人：FRESENIUS KABI USA
申请人全名：FRESENIUS KABI USA LLC
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 Yes AP 1987/03/17 1987/03/17 Prescription
002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No Yes AP 1987/07/31 Prescription
003 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 5GM BASE/VIAL No Yes AP 1988/06/03 Prescription
004 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 10GM BASE/VIAL No Yes AP 1997/11/28 Prescription
005 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL No No AP 2016/08/17 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
2021/05/24 SUPPL-94（补充） Approval Labeling STANDARD
2020/08/27 SUPPL-90（补充） Approval Labeling STANDARD
2020/08/27 SUPPL-86（补充） Approval Labeling STANDARD
2017/07/12 SUPPL-85（补充） Approval Labeling STANDARD
2017/07/12 SUPPL-83（补充） Approval Labeling STANDARD
2016/02/16 SUPPL-57（补充） Approval Labeling
2016/02/16 SUPPL-55（补充） Approval Labeling
2016/02/16 SUPPL-42（补充） Approval Labeling
2002/12/05 SUPPL-37（补充） Approval Manufacturing (CMC)
2002/12/02 SUPPL-36（补充） Approval Manufacturing (CMC)
2002/12/02 SUPPL-35（补充） Approval Manufacturing (CMC)
2001/10/18 SUPPL-32（补充） Approval Manufacturing (CMC)
2000/12/13 SUPPL-30（补充） Approval Manufacturing (CMC)
2000/12/13 SUPPL-29（补充） Approval Manufacturing (CMC)
2000/12/13 SUPPL-27（补充） Approval Manufacturing (CMC)
2000/12/13 SUPPL-26（补充） Approval Manufacturing (CMC)
2000/09/11 SUPPL-28（补充） Approval Manufacturing (CMC)
2000/02/01 SUPPL-24（补充） Approval Manufacturing (CMC)
1999/10/25 SUPPL-23（补充） Approval Manufacturing (CMC)
1999/10/18 SUPPL-22（补充） Approval Manufacturing (CMC)
1998/02/11 SUPPL-21（补充） Approval Manufacturing (CMC)
1997/11/28 SUPPL-20（补充） Approval Labeling
1997/11/28 SUPPL-19（补充） Approval Manufacturing (CMC)
1996/07/05 SUPPL-18（补充） Approval Manufacturing (CMC)
1996/03/12 SUPPL-17（补充） Approval Labeling
1995/04/03 SUPPL-16（补充） Approval Labeling
1994/11/30 SUPPL-14（补充） Approval Manufacturing (CMC)
1994/11/30 SUPPL-13（补充） Approval Manufacturing (CMC)
1992/08/04 SUPPL-15（补充） Approval Labeling
1991/12/23 SUPPL-8（补充） Approval Manufacturing (CMC)
1991/06/07 SUPPL-9（补充） Approval Manufacturing (CMC)
1990/11/20 SUPPL-10（补充） Approval Labeling
1988/08/11 SUPPL-7（补充） Approval Manufacturing (CMC)
1988/06/03 SUPPL-4（补充） Approval Manufacturing (CMC)
1987/03/17 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
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 Prescription 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 HAINAN POLY
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 Prescription 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 HAINAN POLY
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
活性成分:VANCOMYCIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 750MG 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
062912 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Prescription No No AP 2009/01/07 HOSPIRA
062933 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Prescription No No AP 2009/05/27 HOSPIRA
062663 005 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Prescription No No AP 2016/08/17 FRESENIUS KABI USA
206616 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Prescription No No AP 2018/10/03 HIKMA PHARMS
213059 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Discontinued No No AP 2022/02/15 KNACK
215195 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 750MG BASE/VIAL Prescription No No AP 2022/09/15 MEITHEAL
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药品NDC数据与药品包装、标签说明书
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