药品注册申请号:017001
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US 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 ANCOBON FLUCYTOSINE CAPSULE;ORAL 250MG Yes No AB 1971/11/26 Approved Prior to Jan 1, 1982 Prescription
002 ANCOBON FLUCYTOSINE CAPSULE;ORAL 500MG Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/02/12 SUPPL 33 Approval Labeling STANDARD
2017/11/08 SUPPL 32 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/02/05 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
2014/01/08 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
2009/05/04 SUPPL 28 Approval Labeling STANDARD
2006/08/10 SUPPL 27 Approval Labeling STANDARD
2003/04/30 SUPPL 20 Approval Labeling STANDARD
2003/04/30 SUPPL 19 Approval Labeling STANDARD
2000/02/03 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1999/09/29 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1997/08/27 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1997/07/31 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1987/06/01 SUPPL 13 Approval Labeling
1984/08/08 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1983/12/21 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1982/12/06 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1982/01/27 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1981/04/23 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1979/11/26 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1978/08/24 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1978/01/03 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1977/08/11 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1977/05/13 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1971/11/26 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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 Prescription No No AB 2017/10/17 WEST-WARD PHARMS INT
207536 001 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 250MG Prescription No No AB 2018/06/18 RECIPHARM
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 Prescription No No AB 2017/10/17 WEST-WARD PHARMS INT
207536 002 ANDA FLUCYTOSINE FLUCYTOSINE CAPSULE;ORAL 500MG Prescription No No AB 2018/06/18 RECIPHARM
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