药品注册申请号:011856
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:PHARMACIA AND UPJOHN CO
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
003 SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Yes Yes AP 1959/05/18 Approved Prior to Jan 1, 1982 Prescription
004 SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
005 SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
006 SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
007 SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Yes Yes AP 1985/02/27 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
2018/07/24 SUPPL 133 Approval Labeling STANDARD
2018/03/28 SUPPL 131 Approval Labeling STANDARD
2016/09/08 SUPPL 126 Approval Labeling STANDARD
2016/09/08 SUPPL 124 Approval Labeling STANDARD
2015/08/06 SUPPL 127 Approval Manufacturing (CMC) STANDARD
2014/07/22 SUPPL 121 Approval Manufacturing (CMC) STANDARD
2014/07/03 SUPPL 123 Approval Labeling STANDARD
2014/06/09 SUPPL 122 Approval Manufacturing (CMC) STANDARD
2014/04/04 SUPPL 116 Approval Manufacturing (CMC) STANDARD
2014/03/28 SUPPL 119 Approval Manufacturing (CMC) STANDARD
2011/10/20 SUPPL 104 Approval Labeling UNKNOWN
2011/10/20 SUPPL 103 Approval Manufacturing (CMC) STANDARD
2010/06/24 SUPPL 107 Approval Labeling UNKNOWN
2002/10/21 SUPPL 94 Approval Manufacturing (CMC) STANDARD
2000/04/03 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1999/03/16 SUPPL 92 Approval Manufacturing (CMC) STANDARD
1998/02/26 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1994/09/15 SUPPL 87 Approval Manufacturing (CMC) STANDARD
1994/04/22 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1994/04/06 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1994/03/25 SUPPL 81 Approval Manufacturing (CMC) STANDARD
1993/11/05 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1991/09/04 SUPPL 77 Approval Labeling
1990/12/07 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1990/04/24 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1989/10/02 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1989/07/11 SUPPL 68 Approval Manufacturing (CMC) STANDARD
1989/03/22 SUPPL 55 Approval Labeling
1986/12/08 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1986/12/08 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1986/02/14 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1986/01/23 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1985/03/28 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1985/02/27 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1983/05/03 SUPPL 54 Approval Labeling
1981/10/16 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1981/08/11 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1981/02/20 SUPPL 50 Approval Labeling
1980/09/30 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1980/04/28 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1979/11/13 SUPPL 43 Approval Labeling
1959/05/18 ORIG 1 Approval Type 2 - New Active Ingredient 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
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
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 PHARMS CO
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 PHARMS CO
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 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
011856 006 NDA SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040612 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2004/08/12 FRESENIUS KABI USA
040888 004 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/18 SAGENT PHARMS INC
202691 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM 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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