药品注册申请号:050775
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 XL CLARITHROMYCIN TABLET, EXTENDED RELEASE;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2000/03/03 2000/03/03 Discontinued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 29 Approval Labeling STANDARD
2018/12/19 SUPPL 28 Approval Labeling STANDARD
2018/11/25 SUPPL 27 Approval Labeling STANDARD
2017/06/09 SUPPL 26 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 22 Approval Labeling STANDARD
2015/10/23 SUPPL 25 Approval Labeling STANDARD
2015/01/08 SUPPL 24 Approval Labeling STANDARD
2014/07/25 SUPPL 23 Approval Labeling STANDARD
2013/09/09 SUPPL 21 Approval Labeling STANDARD
2013/09/09 SUPPL 20 Approval Labeling STANDARD
2012/07/05 SUPPL 18 Approval Labeling STANDARD
2012/06/01 SUPPL 17 Approval Labeling STANDARD
2012/05/03 SUPPL 19 Approval Labeling STANDARD
2012/05/03 SUPPL 15 Approval Labeling STANDARD
2011/05/27 SUPPL 16 Approval Labeling STANDARD
2011/05/27 SUPPL 14 Approval Labeling STANDARD
2009/08/14 SUPPL 13 Approval Labeling STANDARD
2008/12/04 SUPPL 37 Approval Labeling STANDARD
2008/05/22 SUPPL 12 Approval Labeling STANDARD
2007/12/18 SUPPL 11 Approval Labeling STANDARD
2006/07/05 SUPPL 9 Approval Labeling STANDARD
2005/10/04 SUPPL 8 Approval Labeling STANDARD
2004/07/19 SUPPL 7 Approval Labeling STANDARD
2003/04/11 SUPPL 4 Approval Labeling STANDARD
2002/12/20 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2002/03/15 SUPPL 2 Approval Labeling STANDARD
2001/11/16 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2001/08/02 SUPPL 1 Approval Efficacy STANDARD
2000/03/03 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
001 6010718 2017/04/11 Y U-924 PDF格式**本条是由Drugfuture回溯的历史信息**
6551616 2017/07/15 U-924 PDF格式**本条是由Drugfuture回溯的历史信息**
6552616 2017/07/15 U-924 PDF格式**本条是由Drugfuture回溯的历史信息**
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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