药品注册申请号:011153
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 MEDROL METHYLPREDNISOLONE TABLET;ORAL 4MG Yes No AB 1957/10/24 Approved Prior to Jan 1, 1982 Prescription
002 MEDROL METHYLPREDNISOLONE TABLET;ORAL 2MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
003 MEDROL METHYLPREDNISOLONE TABLET;ORAL 16MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
004 MEDROL METHYLPREDNISOLONE TABLET;ORAL 8MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
005 MEDROL METHYLPREDNISOLONE TABLET;ORAL 24MG No No None Approved Prior to Jan 1, 1982 Discontinued
006 MEDROL METHYLPREDNISOLONE TABLET;ORAL 32MG Yes Yes AB Approved Prior to Jan 1, 1982 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
2024/06/05 SUPPL-83(补充) Approval Labeling STANDARD
2023/12/19 SUPPL-81(补充) Approval Labeling STANDARD
2019/08/26 SUPPL-77(补充) Approval Manufacturing (CMC) N/A
2018/07/24 SUPPL-75(补充) Approval Labeling STANDARD
2013/07/18 SUPPL-71(补充) Approval Manufacturing (CMC) STANDARD
2002/10/25 SUPPL-59(补充) Approval Manufacturing (CMC) STANDARD
1999/12/01 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1993/12/28 SUPPL-51(补充) Approval Labeling
1993/01/28 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1989/01/05 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1987/02/24 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1983/03/09 SUPPL-46(补充) Approval Labeling
1980/10/08 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1980/04/14 SUPPL-43(补充) Approval Labeling
1979/05/30 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1979/04/05 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1979/04/05 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1978/04/11 SUPPL-41(补充) Approval Labeling
1976/09/10 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1957/10/24 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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 剂型/给药途径:TABLET;ORAL 规格:4MG 治疗等效代码:AB
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
011153 001 NDA MEDROL METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
040232 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 1997/10/16 WATSON LABS
040189 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 1997/10/31 JUBILANT CADISTA
040194 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 1997/10/31 SANDOZ
040183 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 1998/12/22 ENDO OPERATIONS
206751 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 2018/04/23 ZYDUS PHARMS
204072 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Prescription No No AB 2018/05/14 TIANJIN TIANYAO
212262 001 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 4MG Discontinued No No AB 2019/06/27 PRAXGEN
活性成分:METHYLPREDNISOLONE 剂型/给药途径:TABLET;ORAL 规格:2MG 治疗等效代码:AB
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
011153 002 NDA MEDROL METHYLPREDNISOLONE TABLET;ORAL 2MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
活性成分:METHYLPREDNISOLONE 剂型/给药途径:TABLET;ORAL 规格:16MG 治疗等效代码:AB
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
011153 003 NDA MEDROL METHYLPREDNISOLONE TABLET;ORAL 16MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
040189 003 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 16MG Prescription No No AB 2007/07/20 JUBILANT CADISTA
206751 003 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 16MG Prescription No No AB 2018/04/23 ZYDUS PHARMS
活性成分:METHYLPREDNISOLONE 剂型/给药途径:TABLET;ORAL 规格:8MG 治疗等效代码:AB
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
011153 004 NDA MEDROL METHYLPREDNISOLONE TABLET;ORAL 8MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
040189 002 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 8MG Prescription No No AB 1997/10/31 JUBILANT CADISTA
206751 002 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 8MG Prescription No No AB 2018/04/23 ZYDUS PHARMS
活性成分:METHYLPREDNISOLONE 剂型/给药途径:TABLET;ORAL 规格:32MG 治疗等效代码:AB
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
011153 006 NDA MEDROL METHYLPREDNISOLONE TABLET;ORAL 32MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PFIZER
040189 004 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 32MG Prescription No No AB 2007/07/20 JUBILANT CADISTA
206751 004 ANDA METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET;ORAL 32MG Prescription No No AB 2018/04/23 ZYDUS PHARMS
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