药品注册申请号：215197
申请类型：ANDA (仿制药申请)
申请人：MEITHEAL
申请人全名：MEITHEAL 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 500MG BASE/VIAL No No AP 2022/07/28 2022/07/28 Prescription
002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP 2022/07/28 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/07/28 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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 Prescription No No AP 2008/06/30 MEDIMETRIKS PHARMS
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 PLANO PHARMS
204107 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2015/12/28 HIKMA
205694 001 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2016/01/21 GLAND
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 SLATE RUN PHARMA
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 Prescription No No AP 2008/06/30 MEDIMETRIKS PHARMS
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 PLANO PHARMS
204107 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2015/12/28 HIKMA
205694 002 ANDA VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2016/01/21 GLAND
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 SLATE RUN PHARMA
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
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药品NDC数据与药品包装、标签说明书
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