药品注册申请号:040557
申请类型:ANDA (仿制药申请)
申请人:HONG KONG
申请人全名:HONG KONG KING FRIEND INDUSTRIAL CO 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 ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML No No AB 2005/02/23 2005/02/23 Prescription
002 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML No No AB 2005/02/23 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
2022/07/06 SUPPL-34(补充) Approval Labeling STANDARD
2020/08/07 SUPPL-30(补充) Approval Labeling STANDARD
2020/08/07 SUPPL-27(补充) Approval Labeling STANDARD
2012/01/03 SUPPL-16(补充) Approval Labeling
2010/12/01 SUPPL-3(补充) Approval Labeling
2005/02/23 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
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 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 PAR STERILE PRODUCTS
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 SLAYBACK PHARMA LLC
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: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 PAR STERILE PRODUCTS
214870 001 ANDA METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Prescription No No AB 2023/01/03 SLAYBACK PHARMA LLC
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
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