药品注册申请号:213665
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA LTD
申请人全名:AUROBINDO PHARMA 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 FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG No No AB 2020/05/01 2020/05/01 Prescription
002 FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG No No AB 2020/05/01 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
2022/09/29 SUPPL-2(补充) Approval Labeling STANDARD
2020/05/01 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:FLUCYTOSINE 剂型/给药途径:CAPSULE;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
017001 001 NDA ANCOBON FLUCYTOSINE CAPSULE;ORAL 250MG Prescription Yes No AB Approved Prior to Jan 1, 1982 BAUSCH
201566 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Prescription No No AB 2011/06/28 SIGMAPHARM LABS LLC
204652 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Prescription No No AB 2017/07/07 NOVEL LABS INC
206550 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Discontinued No No AB 2017/10/17 HIKMA
212632 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Prescription No No AB 2020/04/17 STRIDES PHARMA
213665 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Prescription No No AB 2020/05/01 AUROBINDO PHARMA LTD
活性成分:FLUCYTOSINE 剂型/给药途径:CAPSULE;ORAL 规格:500MG 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
017001 002 NDA ANCOBON FLUCYTOSINE CAPSULE;ORAL 500MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 BAUSCH
201566 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Prescription No No AB 2011/06/28 SIGMAPHARM LABS LLC
204652 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Prescription No No AB 2017/07/07 NOVEL LABS INC
206550 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Discontinued No No AB 2017/10/17 HIKMA
212632 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Prescription No No AB 2020/04/17 STRIDES PHARMA
213665 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Prescription No No AB 2020/05/01 AUROBINDO PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
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