药品注册申请号：210525
申请类型：ANDA (仿制药申请)
申请人：GENEYORK PHARMS
申请人全名：GENEYORK PHARMACEUTICALS GROUP LLC
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 PREDNISONE PREDNISONE TABLET;ORAL 10MG No No AB 2018/12/04 2018/12/04 Discontinued
002 PREDNISONE PREDNISONE TABLET;ORAL 20MG No No AB 2018/12/04 Discontinued
003 PREDNISONE PREDNISONE TABLET;ORAL 50MG No No AB 2018/12/04 Discontinued
004 PREDNISONE PREDNISONE TABLET;ORAL 2.5MG No No AB 2018/12/07 Discontinued
005 PREDNISONE PREDNISONE TABLET;ORAL 5MG No No AB 2018/12/07 Discontinued
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
2018/12/04 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:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
084122 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 HIKMA
085162 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
088832 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 1985/12/04 MYLAN
089247 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 1985/12/04 SUN PHARM INDUSTRIES
040362 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2001/08/29 JUBILANT CADISTA
040256 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2002/07/12 VINTAGE PHARMS
210525 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Discontinued No No AB 2018/12/04 GENEYORK PHARMS
211575 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
213386 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2020/06/24 AMNEAL
208412 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2021/02/11 STRIDES PHARMA
215672 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2022/03/28 AUROBINDO PHARMA LTD
212629 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 10MG Prescription No No AB 2023/12/05 GRANULATION TECH
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:20MG 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
083677 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
085161 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
087342 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 HIKMA
089247 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 1985/12/04 SUN PHARM INDUSTRIES
040392 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2003/02/12 VINTAGE PHARMS
040362 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2005/06/29 JUBILANT CADISTA
210525 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Discontinued No No AB 2018/12/04 GENEYORK PHARMS
211575 004 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
213386 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2020/06/24 AMNEAL
208412 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2021/02/11 STRIDES PHARMA
215672 004 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2022/03/28 AUROBINDO PHARMA LTD
212629 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 20MG Prescription No No AB 2023/12/05 GRANULATION TECH
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
084283 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 HIKMA
210525 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Discontinued No No AB 2018/12/04 GENEYORK PHARMS
211575 005 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
208412 003 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Prescription No No AB 2022/01/11 STRIDES PHARMA
215672 005 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Prescription No No AB 2022/03/28 AUROBINDO PHARMA LTD
040362 005 ANDA PREDNISONE PREDNISONE TABLET;ORAL 50MG Prescription No No AB 2023/04/17 JUBILANT CADISTA
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
087801 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription Yes Yes AB 1982/04/22 HIKMA
040581 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription No No AB 2004/12/21 VINTAGE PHARMS
210525 004 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Discontinued No No AB 2018/12/07 GENEYORK PHARMS
211575 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
209727 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription No No AB 2020/11/20 STRIDES PHARMA
215672 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription No No AB 2022/03/28 AUROBINDO PHARMA LTD
040362 004 ANDA PREDNISONE PREDNISONE TABLET;ORAL 2.5MG Prescription No No AB 2023/04/17 JUBILANT CADISTA
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
080292 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
080352 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 HIKMA
080356 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
089247 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 1985/12/04 SUN PHARM INDUSTRIES
040362 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2001/08/29 JUBILANT CADISTA
040256 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2002/07/12 VINTAGE PHARMS
210525 005 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Discontinued No No AB 2018/12/07 GENEYORK PHARMS
211575 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
213385 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2020/06/16 AMNEAL
209727 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2020/11/20 STRIDES PHARMA
215672 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2022/03/28 AUROBINDO PHARMA LTD
212629 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2023/12/05 GRANULATION TECH
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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