药品注册申请号：040843
申请类型：ANDA (仿制药申请)
申请人：PHARMACHEMIE BV
申请人全名：PHARMACHEMIE BV
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 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) No No AP 2010/01/08 2010/01/11 Prescription
002 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) No No AP 2010/01/11 Prescription
003 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 100MG BASE/4ML (EQ 25MG BASE/ML) No No None 2012/02/27 Prescription
004 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) No No AP 2010/01/11 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
2021/08/02 SUPPL-11（补充） Approval Labeling STANDARD
2021/08/02 SUPPL-7（补充） Approval Labeling STANDARD
2017/02/24 SUPPL-5（补充） Approval Labeling STANDARD
2012/03/30 SUPPL-1（补充） Approval Labeling
2010/01/08 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:METHOTREXATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/40ML (EQ 25MG BASE/ML) 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
011719 012 NDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) Prescription Yes Yes AP 2005/04/13 HOSPIRA
040716 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) Prescription No Yes AP 2007/04/30 ACCORD HLTHCARE
090029 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) Prescription No No AP 2009/03/31 SANDOZ
040843 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) Prescription No No AP 2010/01/11 PHARMACHEMIE BV
203407 003 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 1GM BASE/40ML (EQ 25MG BASE/ML) Prescription No No AP 2018/08/09 SAGENT PHARMS INC
活性成分:METHOTREXATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/2ML (EQ 25MG BASE/ML) 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
040850 001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No No AP --
089340 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No Yes AP 1986/09/16 HIKMA
040263 001 ANDA METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No Yes AP 1999/02/26 FRESENIUS KABI USA
011719 010 NDA METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription Yes Yes AP 2004/12/15 HOSPIRA
040767 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No Yes AP 2007/04/30 ACCORD HLTHCARE
090039 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No No AP 2009/03/31 SANDOZ
040843 002 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No No AP 2010/01/11 PHARMACHEMIE BV
203407 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 50MG BASE/2ML (EQ 25MG BASE/ML) Prescription No No AP 2018/08/09 SAGENT PHARMS INC
活性成分:METHOTREXATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 250MG BASE/10ML (EQ 25MG BASE/ML) 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
089343 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) Prescription No No AP 1986/09/16 HIKMA
040768 001 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) Prescription No Yes AP 2007/04/30 ACCORD HLTHCARE
090039 002 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) Prescription No No AP 2009/03/31 SANDOZ
040843 004 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) Prescription No No AP 2010/01/11 PHARMACHEMIE BV
203407 002 ANDA METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE;INJECTION EQ 250MG BASE/10ML (EQ 25MG BASE/ML) Prescription No No AP 2018/08/09 SAGENT PHARMS INC
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database