药品注册申请号:207667
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA LTD
申请人全名:AUROBINDO PHARMA 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 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL No No AP 2015/12/15 2015/12/15 Prescription
002 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL No No AP 2015/12/15 Prescription
003 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 2015/12/15 Prescription
004 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No AP 2015/12/15 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/12/15 ORIG 1 Approval STANDARD
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
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与本品治疗等效的药品
活性成分:METHYLPREDNISOLONE SODIUM SUCCINATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 40MG 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
011856 003 NDA SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040583 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2004/07/30 FRESENIUS KABI USA
040888 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2011/07/18 SAGENT PHARMS INC
207667 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2015/12/15 AUROBINDO PHARMA LTD
207549 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2016/11/09 AMNEAL
活性成分:METHYLPREDNISOLONE SODIUM SUCCINATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 125MG 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
011856 004 NDA SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040583 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2004/07/30 FRESENIUS KABI USA
040888 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2011/07/18 SAGENT PHARMS INC
207667 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2015/12/15 AUROBINDO PHARMA LTD
207549 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2016/11/09 AMNEAL
活性成分:METHYLPREDNISOLONE SODIUM SUCCINATE 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
011856 005 NDA SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040888 003 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2011/07/18 SAGENT PHARMS INC
207667 003 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2015/12/15 AUROBINDO PHARMA LTD
202691 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2016/02/16 HIKMA
活性成分:METHYLPREDNISOLONE SODIUM SUCCINATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM 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
011856 007 NDA SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription Yes Yes AP 1985/02/27 PHARMACIA AND UPJOHN
040888 005 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2011/07/18 SAGENT PHARMS INC
207667 004 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2015/12/15 AUROBINDO PHARMA LTD
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