药品注册申请号:050670
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER CHEMICALS DIV 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ZITHROMAX AZITHROMYCIN CAPSULE;ORAL EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1991/11/01 1991/11/01 Discontinued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
2019/04/24 SUPPL 34 Approval Labeling STANDARD
2017/03/30 SUPPL 32 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2007/10/25 SUPPL 24 Approval Labeling STANDARD
2004/03/24 SUPPL 21 Approval Labeling STANDARD
2004/01/15 SUPPL 22 Approval Labeling STANDARD
2002/10/16 SUPPL 17 Approval Labeling STANDARD
2002/07/22 SUPPL 19 Approval Labeling STANDARD
2000/11/13 SUPPL 15 Approval Efficacy UNKNOWN
2000/11/11 SUPPL 14 Approval Labeling STANDARD
1999/11/22 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1999/02/24 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1996/12/20 SUPPL 10 Approval Efficacy STANDARD
1996/11/22 SUPPL 8 Approval Efficacy STANDARD
1996/07/12 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1996/02/29 SUPPL 3 Approval Labeling STANDARD
1994/05/11 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1993/11/30 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1993/11/30 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1992/04/13 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1992/02/11 SUPPL 2 Approval Labeling
1991/11/01 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品治疗等效的药品
本品无治疗等效药品
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