药品注册申请号:050784
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 500MG BASE Yes No AB 2002/05/24 2002/05/24 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 34 Approval Labeling STANDARD
2017/03/30 SUPPL 30 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 28 Approval Labeling STANDARD
2016/05/23 SUPPL 27 Approval Labeling STANDARD
2014/06/07 SUPPL 21 Approval Labeling STANDARD
2013/02/19 SUPPL 23 Approval Labeling STANDARD
2012/11/02 SUPPL 19 Approval Labeling STANDARD
2012/06/06 SUPPL 22 Approval Labeling STANDARD
2011/01/28 SUPPL 18 Approval Labeling STANDARD
2010/08/11 SUPPL 17 Approval Labeling UNKNOWN
2009/03/06 SUPPL 12 Approval Labeling STANDARD
2007/10/25 SUPPL 7 Approval Labeling STANDARD
2004/01/15 SUPPL 6 Approval Labeling STANDARD
2004/01/15 SUPPL 4 Approval Efficacy STANDARD
2003/12/18 SUPPL 5 Approval Labeling STANDARD
2002/12/17 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2002/10/16 SUPPL 2 Approval Labeling STANDARD
2002/05/24 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 500MG 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
050784 001 NDA ZITHROMAX AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription Yes No AB 2002/05/24 PFIZER
065193 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2005/11/14 TEVA
065212 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2005/11/14 SANDOZ
065223 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2005/11/14 PLIVA
065405 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2008/02/11 WOCKHARDT
065399 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2015/05/15 LUPIN LTD
207398 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2018/07/05 AUROBINDO PHARMA LTD
208249 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2018/10/25 CSPC OUYI
209044 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2018/12/07 SUNSHINE LAKE
210001 001 ANDA AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Prescription No No AB 2019/02/26 BIONPHARMA INC
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