药品注册申请号:050662
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE 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001 BIAXIN CLARITHROMYCIN TABLET;ORAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1991/10/31 1991/10/31 Discontinued
002 BIAXIN CLARITHROMYCIN TABLET;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1991/10/31 Discontinued
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
2019/09/18 SUPPL 61 Approval Labeling STANDARD
2018/12/19 SUPPL 60 Approval Labeling STANDARD
2018/11/25 SUPPL 59 Approval Labeling STANDARD
2017/06/09 SUPPL 58 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/05/26 SUPPL 54 Approval Labeling STANDARD
2015/10/23 SUPPL 57 Approval Labeling STANDARD
2015/01/08 SUPPL 56 Approval Labeling STANDARD
2014/07/25 SUPPL 55 Approval Labeling STANDARD
2013/09/09 SUPPL 53 Approval Labeling STANDARD
2013/09/09 SUPPL 52 Approval Labeling STANDARD
2012/11/23 SUPPL 49 Approval Manufacturing (CMC) PRIORITY
2012/07/05 SUPPL 48 Approval Labeling STANDARD
2012/06/01 SUPPL 46 Approval Labeling STANDARD
2012/05/03 SUPPL 50 Approval Labeling STANDARD
2012/05/03 SUPPL 44 Approval Labeling STANDARD
2011/05/27 SUPPL 45 Approval Labeling UNKNOWN
2011/05/27 SUPPL 43 Approval Labeling STANDARD
2009/08/14 SUPPL 42 Approval Labeling STANDARD
2008/05/22 SUPPL 41 Approval Labeling STANDARD
2007/12/18 SUPPL 40 Approval Labeling STANDARD
2006/07/05 SUPPL 39 Approval Labeling STANDARD
2005/10/04 SUPPL 38 Approval Labeling STANDARD
2004/07/19 SUPPL 36 Approval Labeling STANDARD
2002/11/08 SUPPL 33 Approval Manufacturing (CMC) PRIORITY
2002/06/06 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
2002/06/06 SUPPL 31 Approval Labeling STANDARD
2002/06/06 SUPPL 30 Approval Labeling STANDARD
2000/10/20 SUPPL 29 Approval Efficacy STANDARD
2000/03/20 SUPPL 28 Approval Labeling STANDARD
1999/10/22 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1999/07/29 SUPPL 26 Approval Labeling STANDARD
1999/05/04 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1998/11/10 SUPPL 24 Approval Labeling STANDARD
1998/09/16 SUPPL 20 Approval Efficacy STANDARD
1998/07/21 SUPPL 22 Approval Labeling STANDARD
1998/04/27 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1998/01/05 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1997/09/16 SUPPL 19 Approval Efficacy STANDARD
1997/09/16 SUPPL 18 Approval Labeling STANDARD
1997/08/26 SUPPL 12 Approval Labeling STANDARD
1997/04/29 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1997/01/16 SUPPL 15 Approval Efficacy STANDARD
1997/01/14 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1996/12/20 SUPPL 13 Approval Labeling STANDARD
1996/10/15 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1996/04/18 SUPPL 10 Approval Efficacy PRIORITY
1995/08/31 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1995/03/13 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1995/02/28 SUPPL 4 Approval Efficacy UNKNOWN
1995/02/28 SUPPL 3 Approval Labeling STANDARD
1993/12/23 SUPPL 8 Approval Labeling STANDARD
1993/09/15 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1993/06/08 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1993/01/28 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1992/06/17 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1991/10/31 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)
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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
本品无治疗等效药品
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