药品注册申请号:077621
申请类型:ANDA (仿制药申请)
申请人:ZYDUS PHARMS USA
申请人全名:ZYDUS PHARMACEUTICALS USA 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 AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG No No AB 2007/03/15 2007/03/15 Prescription
002 AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 25MG No No AB 2008/09/05 Prescription
003 AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 75MG No No AB 2008/09/05 Prescription
004 AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 100MG No No AB 2008/09/05 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
2019/04/23 SUPPL-13(补充) Approval Labeling STANDARD
2015/07/20 SUPPL-8(补充) Approval Labeling STANDARD
2011/06/20 SUPPL-5(补充) Approval Labeling
2009/02/17 SUPPL-4(补充) Approval Labeling
2008/09/05 SUPPL-2(补充) Approval Labeling
2007/03/15 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:AZATHIOPRINE 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
016324 001 NDA IMURAN AZATHIOPRINE TABLET;ORAL 50MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SEBELA IRELAND LTD
074069 001 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG Prescription No No AB 1996/02/16 AMNEAL
075252 001 ANDA AZASAN AZATHIOPRINE TABLET;ORAL 50MG Prescription No No AB 1999/06/07 AAIPHARMA LLC
075568 001 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG Prescription No No AB 1999/12/13 RISING
077621 001 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG Prescription No No AB 2007/03/15 ZYDUS PHARMS USA
208687 002 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 50MG Prescription No No AB 2020/03/27 ALKEM LABS LTD
活性成分:AZATHIOPRINE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
075252 002 ANDA AZASAN AZATHIOPRINE TABLET;ORAL 25MG Prescription No No AB 2003/02/03 AAIPHARMA LLC
077621 002 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 25MG Prescription No No AB 2008/09/05 ZYDUS PHARMS USA
208687 001 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 25MG Prescription No No AB 2020/03/27 ALKEM LABS LTD
活性成分:AZATHIOPRINE 剂型/给药途径:TABLET;ORAL 规格: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
075252 003 ANDA AZASAN AZATHIOPRINE TABLET;ORAL 75MG Prescription No No AB 2003/02/03 AAIPHARMA LLC
077621 003 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 75MG Prescription No No AB 2008/09/05 ZYDUS PHARMS USA
208687 003 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 75MG Prescription No No AB 2020/03/27 ALKEM LABS LTD
074069 002 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 75MG Prescription No No AB 2021/11/02 AMNEAL
活性成分:AZATHIOPRINE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
075252 004 ANDA AZASAN AZATHIOPRINE TABLET;ORAL 100MG Prescription No No AB 2003/02/03 AAIPHARMA LLC
077621 004 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 100MG Prescription No No AB 2008/09/05 ZYDUS PHARMS USA
208687 004 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 100MG Prescription No No AB 2020/03/27 ALKEM LABS LTD
074069 003 ANDA AZATHIOPRINE AZATHIOPRINE TABLET;ORAL 100MG Prescription No No AB 2021/11/02 AMNEAL
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