药品注册申请号:050693
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER CENTRAL RESEARCH
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 FOR SUSPENSION;ORAL EQ 1GM BASE/PACKET Yes Yes None 1994/09/28 1994/09/28 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 31 Approval Labeling STANDARD
2017/03/29 SUPPL 29 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 27 Approval Labeling STANDARD
2016/05/23 SUPPL 26 Approval Labeling STANDARD
2014/11/05 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2014/06/06 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 17 Approval Labeling STANDARD
2010/08/11 SUPPL 15 Approval Labeling STANDARD
2009/03/06 SUPPL 14 Approval Labeling STANDARD
2007/10/25 SUPPL 10 Approval Labeling STANDARD
2004/03/24 SUPPL 8 Approval Labeling STANDARD
2004/01/15 SUPPL 9 Approval Labeling STANDARD
2002/10/16 SUPPL 5 Approval Labeling STANDARD
2002/07/22 SUPPL 7 Approval Labeling STANDARD
2000/11/13 SUPPL 3 Approval Efficacy UNKNOWN
2000/11/11 SUPPL 2 Approval Labeling STANDARD
1999/11/22 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1994/09/28 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
本品无治疗等效药品
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