药品注册申请号:050711
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 ZITHROMAX AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Yes No AB 1996/07/18 1996/07/18 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
2019/04/24 SUPPL 47 Approval Labeling STANDARD
2017/03/30 SUPPL 43 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/02/10 SUPPL 41 Approval Labeling STANDARD
2016/05/23 SUPPL 40 Approval Labeling STANDARD
2014/06/07 SUPPL 34 Approval Labeling STANDARD
2013/02/19 SUPPL 36 Approval Labeling STANDARD
2012/11/02 SUPPL 32 Approval Labeling STANDARD
2012/06/06 SUPPL 35 Approval Labeling STANDARD
2011/01/28 SUPPL 31 Approval Labeling STANDARD
2010/08/11 SUPPL 30 Approval Labeling UNKNOWN
2009/03/06 SUPPL 24 Approval Labeling STANDARD
2007/10/25 SUPPL 19 Approval Labeling STANDARD
2004/01/15 SUPPL 17 Approval Labeling STANDARD
2004/01/15 SUPPL 15 Approval Labeling STANDARD
2003/12/18 SUPPL 16 Approval Labeling STANDARD
2002/10/16 SUPPL 8 Approval Labeling STANDARD
2002/07/22 SUPPL 12 Approval Labeling STANDARD
2002/05/24 SUPPL 9 Approval Labeling STANDARD
2002/05/20 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2000/11/11 SUPPL 6 Approval Labeling STANDARD
2000/02/09 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1999/12/06 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/11/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/10/06 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1999/07/15 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1997/05/16 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/07/18 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 6268489 2018/07/31 Y 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
活性成分:AZITHROMYCIN 剂型/给药途径:TABLET;ORAL 规格:EQ 250MG BASE 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
050711 001 NDA ZITHROMAX AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription Yes No AB 1996/07/18 PFIZER
065211 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2005/11/14 SANDOZ
065225 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2005/11/14 PLIVA
065404 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2008/02/11 WOCKHARDT
065398 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2015/05/15 LUPIN LTD
207370 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2018/07/05 AUROBINDO PHARMA LTD
209045 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2018/12/07 SUNSHINE LAKE
210000 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2019/02/26 BIONPHARMA INC
208250 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 250MG BASE Prescription No No AB 2019/04/17 CSPC OUYI
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