药品注册申请号:215101
申请类型:ANDA (仿制药申请)
申请人:RUBICON
申请人全名:RUBICON RESEARCH PRIVATE 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 ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG No No AB 2021/08/19 2021/08/19 Prescription
002 ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG No No AB 2021/08/19 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
2021/08/19 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
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:ACETAZOLAMIDE 剂型/给药途径:TABLET;ORAL 规格:125MG 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
040195 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 1997/05/28 TARO
205530 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2016/10/27 HERITAGE PHARMA
209734 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2017/11/20 STRIDES PHARMA
210588 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2019/10/17 NOVITIUM PHARMA
207503 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Discontinued No No AB 2020/04/30 BRECKENRIDGE
214282 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2020/10/07 MANKIND PHARMA
211372 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2021/02/22 APPCO
215101 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2021/08/19 RUBICON
211069 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2023/04/04 ZYDUS LIFESCIENCES
217197 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2023/05/09 NE RX PHARMA
211151 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Discontinued No No AB 2023/09/11 AJANTA PHARMA LTD
213706 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Discontinued No No AB 2024/01/26 TORRENT
218023 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 125MG Prescription No No AB 2024/05/14 EPIC PHARMA LLC
活性成分:ACETAZOLAMIDE 剂型/给药途径:TABLET;ORAL 规格:250MG 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
084840 001 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 CHARTWELL MOLECULAR
040195 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No Yes AB 1997/05/28 TARO
205530 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2016/10/27 HERITAGE PHARMA
209734 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2017/11/20 STRIDES PHARMA
210588 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2019/10/17 NOVITIUM PHARMA
207503 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Discontinued No No AB 2020/04/30 BRECKENRIDGE
214282 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2020/10/07 MANKIND PHARMA
211372 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2021/02/22 APPCO
215101 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2021/08/19 RUBICON
211069 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2023/04/04 ZYDUS LIFESCIENCES
217197 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2023/05/09 NE RX PHARMA
211151 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Discontinued No No AB 2023/09/11 AJANTA PHARMA LTD
213706 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Discontinued No No AB 2024/01/26 TORRENT
218023 002 ANDA ACETAZOLAMIDE ACETAZOLAMIDE TABLET;ORAL 250MG Prescription No No AB 2024/05/14 EPIC PHARMA LLC
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database