药品注册申请号：011757
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 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Yes No AB 1959/05/27 Approved Prior to Jan 1, 1982 Prescription
002 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 20MG/ML Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
004 DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Yes No 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-125（补充） Approval Labeling STANDARD
2023/12/20 SUPPL-123（补充） Approval Labeling STANDARD
2021/05/27 SUPPL-120（补充） Approval Labeling STANDARD
2021/02/11 SUPPL-119（补充） Approval Labeling STANDARD
2018/07/24 SUPPL-114（补充） Approval Labeling STANDARD
2017/03/15 SUPPL-111（补充） Approval Labeling STANDARD
2016/09/08 SUPPL-104（补充） Approval Labeling STANDARD
2014/07/03 SUPPL-103（补充） Approval Labeling STANDARD
2014/06/09 SUPPL-102（补充） Approval Manufacturing (CMC) STANDARD
2013/10/11 SUPPL-98（补充） Approval Manufacturing (CMC) STANDARD
2013/10/07 SUPPL-97（补充） Approval Manufacturing (CMC) STANDARD
2009/04/07 SUPPL-86（补充） Approval Labeling STANDARD
2009/04/07 SUPPL-85（补充） Approval Labeling STANDARD
2002/05/22 SUPPL-79（补充） Approval Manufacturing (CMC) STANDARD
2000/04/04 SUPPL-78（补充） Approval Manufacturing (CMC) STANDARD
1995/01/24 SUPPL-75（补充） Approval Manufacturing (CMC) STANDARD
1994/01/07 SUPPL-72（补充） Approval Manufacturing (CMC) STANDARD
1993/12/28 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
1990/11/15 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
1989/12/14 SUPPL-63（补充） Approval Labeling
1989/01/05 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1986/05/12 SUPPL-60（补充） Approval Labeling
1986/05/12 SUPPL-55（补充） Approval Labeling
1986/05/12 SUPPL-53（补充） Approval Labeling
1983/03/09 SUPPL-58（补充） Approval Labeling
1983/03/09 SUPPL-57（补充） Approval Labeling
1981/02/17 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
1980/07/29 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1978/07/12 SUPPL-52（补充） Approval Labeling
1959/05/27 ORIG-1（原始申请） 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
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:METHYLPREDNISOLONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/ML 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
011757 001 NDA DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
040557 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2005/02/23 HONG KONG
040620 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Discontinued No No AB 2006/10/27 TEVA PHARMS USA
040719 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2009/01/29 SANDOZ
040794 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2009/03/05 SANDOZ
201835 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No Yes AB 2018/06/27 SAGENT PHARMS INC
210043 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No Yes AB 2019/05/20 AMNEAL
214297 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2022/01/21 ENDO OPERATIONS
211930 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2023/04/13 EUGIA PHARMA
214870 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2023/05/10 WILSHIRE PHARMS INC
216502 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Prescription No No AB 2023/11/03 AMNEAL
活性成分:METHYLPREDNISOLONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/ML 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
011757 002 NDA DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 20MG/ML Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PFIZER
201835 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 20MG/ML Discontinued No No AB 2018/06/27 SAGENT PHARMS INC
活性成分:METHYLPREDNISOLONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:80MG/ML 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
011757 004 NDA DEPO-MEDROL METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
040557 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2005/02/23 HONG KONG
040620 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Discontinued No No AB 2006/10/27 TEVA PHARMS USA
040719 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2009/01/29 SANDOZ
040794 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2009/03/05 SANDOZ
201835 003 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No Yes AB 2018/06/27 SAGENT PHARMS INC
210043 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No Yes AB 2019/05/20 AMNEAL
214297 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2022/01/21 ENDO OPERATIONS
214870 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2023/01/03 WILSHIRE PHARMS INC
211930 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2023/04/13 EUGIA PHARMA
216502 002 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2023/11/03 AMNEAL
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
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