药品注册申请号:050698
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 FOR SUSPENSION;ORAL 125MG/5ML Yes No None 1993/12/23 1993/12/23 Discontinued
002 BIAXIN CLARITHROMYCIN FOR SUSPENSION;ORAL 250MG/5ML Yes No None 1993/12/23 Discontinued
003 BIAXIN CLARITHROMYCIN FOR SUSPENSION;ORAL 187MG/5ML No No None 1998/09/30 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 41 Approval Labeling STANDARD
2018/12/19 SUPPL 40 Approval Labeling STANDARD
2018/11/25 SUPPL 39 Approval Labeling STANDARD
2017/06/09 SUPPL 38 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 33 Approval Labeling STANDARD
2015/10/23 SUPPL 37 Approval Labeling STANDARD
2015/01/08 SUPPL 36 Approval Labeling STANDARD
2014/07/25 SUPPL 35 Approval Labeling STANDARD
2013/10/24 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2013/09/09 SUPPL 32 Approval Labeling STANDARD
2013/09/09 SUPPL 31 Approval Labeling STANDARD
2012/07/05 SUPPL 29 Approval Labeling STANDARD
2012/06/01 SUPPL 28 Approval Labeling STANDARD
2012/05/03 SUPPL 30 Approval Labeling STANDARD
2012/05/03 SUPPL 26 Approval Labeling STANDARD
2011/05/27 SUPPL 27 Approval Labeling STANDARD
2011/05/27 SUPPL 25 Approval Labeling STANDARD
2009/08/14 SUPPL 24 Approval Labeling STANDARD
2008/05/22 SUPPL 23 Approval Labeling STANDARD
2007/12/18 SUPPL 22 Approval Labeling STANDARD
2006/07/05 SUPPL 21 Approval Labeling STANDARD
2005/10/04 SUPPL 20 Approval Labeling STANDARD
2004/07/19 SUPPL 19 Approval Labeling STANDARD
2002/11/21 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2002/05/24 SUPPL 14 Approval Efficacy STANDARD
2000/06/05 SUPPL 11 Approval Labeling STANDARD
1998/09/30 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1997/10/03 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1997/08/26 SUPPL 7 Approval Labeling STANDARD
1996/07/17 SUPPL 1 Approval Efficacy UNKNOWN
1995/10/23 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1994/08/12 SUPPL 4 Approval Efficacy UNKNOWN
1994/08/12 SUPPL 3 Approval Efficacy UNKNOWN
1994/08/12 SUPPL 2 Approval Efficacy UNKNOWN
1994/03/24 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1993/12/23 ORIG 1 Approval Type 3 - New Dosage Form 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
本品无治疗等效药品
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