药品注册申请号：212396
申请类型：ANDA (仿制药申请)
申请人：TIANJIN KINGYORK
申请人全名：TIANJIN KINGYORK PHARMACEUTICALS 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 SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL No No AP 2021/04/20 2021/04/20 Prescription
002 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL No No AP 2021/04/20 Prescription
003 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 2021/04/20 Prescription
004 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP 2021/04/20 Prescription
005 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No AP 2021/04/20 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
2023/09/18 SUPPL-2（补充） Approval Labeling STANDARD
2023/09/18 SUPPL-1（补充） Approval Labeling STANDARD
2021/04/20 ORIG-1（原始申请） 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
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 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 Discontinued No No AP 2015/12/15 EUGIA PHARMA
207549 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2016/11/09 AMNEAL
212396 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2021/04/20 TIANJIN KINGYORK
203125 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 40MG BASE/VIAL Prescription No No AP 2022/09/26 HIKMA
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 Discontinued No No AP 2015/12/15 EUGIA PHARMA
207549 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2016/11/09 AMNEAL
212396 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2021/04/20 TIANJIN KINGYORK
203125 002 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 125MG BASE/VIAL Prescription No No AP 2022/09/26 HIKMA
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 Discontinued No No AP 2015/12/15 EUGIA PHARMA
202691 001 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2016/02/16 HIKMA
212396 003 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2021/04/20 TIANJIN KINGYORK
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
212396 004 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2021/04/20 TIANJIN KINGYORK
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 Discontinued No No AP 2015/12/15 EUGIA PHARMA
212396 005 ANDA METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2021/04/20 TIANJIN KINGYORK
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药品NDC数据与药品包装、标签说明书
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