药品注册申请号：217695
申请类型：ANDA (仿制药申请)
申请人：APOTEX
申请人全名：APOTEX 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 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG No No AB 2023/08/23 2023/08/23 Prescription
002 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG No No AB 2023/08/23 Prescription
003 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1MG No No AB 2023/08/23 Prescription
004 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG No No AB 2023/08/23 Prescription
005 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG No No AB 2023/08/23 Prescription
006 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG No No AB 2023/08/23 Prescription
007 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG No No AB 2023/08/23 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
2024/06/05 SUPPL-1（补充） Approval Labeling STANDARD
2023/08/23 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
003 CGT 2024/04/29
与本品治疗等效的药品
活性成分:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
084611 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 HIKMA
217695 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG Prescription No No AB 2023/08/23 APOTEX
215604 004 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG Prescription No No AB 2023/10/05 NOVITIUM PHARMA
216282 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.5MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:0.75MG 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
084613 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG Prescription Yes No AB Approved Prior to Jan 1, 1982 HIKMA
217695 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG Prescription No No AB 2023/08/23 APOTEX
215604 005 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG Prescription No No AB 2023/10/05 NOVITIUM PHARMA
216282 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 0.75MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
088306 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1MG Prescription Yes Yes AB 1983/09/15 HIKMA
217695 003 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1MG Prescription No No AB 2023/08/23 APOTEX
216284 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1MG Prescription No No AB 2024/05/09 ZYDUS LIFESCIENCES
218372 003 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:1.5MG 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
084610 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 HIKMA
201270 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription No No AB 2017/07/17 LARKEN LABS INC
215604 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription No No AB 2022/08/08 NOVITIUM PHARMA
217695 004 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription No No AB 2023/08/23 APOTEX
216282 003 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 004 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 1.5MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 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
087916 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription Yes Yes AB 1982/08/26 HIKMA
216295 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2022/09/08 AMNEAL
217538 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2023/04/26 BIONPHARMA
217696 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2023/05/09 NOVITIUM PHARMA
217695 005 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2023/08/23 APOTEX
216283 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 005 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 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
084612 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription Yes No AB Approved Prior to Jan 1, 1982 HIKMA
088481 004 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 1983/04/28 ALVOGEN
215106 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2021/10/14 AMNEAL
080399 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2022/04/20 PRASCO
215604 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2022/08/08 NOVITIUM PHARMA
217001 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2023/04/19 BIONPHARMA
217695 006 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2023/08/23 APOTEX
216282 004 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 006 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 4MG Prescription No No AB 2024/09/17 COREPHARMA
活性成分:DEXAMETHASONE 剂型/给药途径:TABLET;ORAL 规格:6MG 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
088316 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription Yes Yes AB 1983/09/15 HIKMA
088481 001 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 1983/11/28 ALVOGEN
215106 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2021/10/14 AMNEAL
215604 003 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2022/08/08 NOVITIUM PHARMA
217001 002 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2023/04/19 BIONPHARMA
217695 007 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2023/08/23 APOTEX
216282 005 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2024/02/07 ZYDUS LIFESCIENCES
218372 007 ANDA DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 6MG Prescription No No AB 2024/09/17 COREPHARMA
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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