| 药品名称 | ZITHROMAX | | 申请号 | 050670 | 产品号 | 001 | | 活性成分 | AZITHROMYCIN | 市场状态 | 停止上市 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1991/11/01 | 申请机构 | PFIZER CHEMICALS DIV PFIZER INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
|
|
| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
|
| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
|
| 与药品注册相关的信息 | | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | | 050670 | 024 | AP | Label | 2007/11/07 | 下载 | | 050670 | 024 | AP | Letter | 2007/11/08 | 下载 | | 050670 | 022 | AP | Letter | 2004/01/22 | 下载 | | 050670 | 021 | AP | Letter | 2004/03/28 | 下载 | | 050670 | 021 | AP | Label | 2004/04/05 | 下载 | | 050670 | 019 | AP | Letter | 2002/07/22 | 下载 | | 050670 | 017 | AP | Letter | 2002/10/16 | 下载 | | 050670 | 015 | AP | Review | 2000/11/13 | 下载 | | 050670 | 015 | AP | Letter | 2000/11/13 | 下载 | | 050670 | 015 | AP | Label | 2000/11/13 | 下载 | | 050670 | 008 | AP | Review | 1997/11/04 | 下载 | | 050670 | 000 | AP | Other Important Information from FDA | 2013/03/15 | 下载 |
|
| 药品注册审批历史信息 | | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | | 050670 | 024 | AP | 2007/10/25 | Labeling Revision | | 050670 | 022 | AP | 2004/01/15 | Labeling Revision | | 050670 | 021 | AP | 2004/03/24 | Labeling Revision | | 050670 | 019 | AP | 2002/07/22 | Labeling Revision | | 050670 | 017 | AP | 2002/10/16 | Labeling Revision | | 050670 | 015 | AP | 2000/11/13 | New or Modified Indication | | 050670 | 014 | AP | 2000/11/11 | Labeling Revision | | 050670 | 013 | AP | 1999/11/22 | Manufacturing Change or Addition | | 050670 | 012 | AP | 1999/02/24 | Control Supplement | | 050670 | 011 | AP | 1996/07/12 | Manufacturing Change or Addition | | 050670 | 010 | AP | 1996/12/20 | Patient Population Altered | | 050670 | 008 | AP | 1996/11/22 | New or Modified Indication | | 050670 | 007 | AP | 1994/05/11 | Manufacturing Change or Addition | | 050670 | 006 | AP | 1993/11/30 | Manufacturing Change or Addition | | 050670 | 005 | AP | 1993/11/30 | Manufacturing Change or Addition | | 050670 | 003 | AP | 1996/02/29 | Labeling Revision | | 050670 | 002 | AP | 1992/02/11 | Labeling Revision | | 050670 | 001 | AP | 1992/04/13 | Package Change | | 050670 | 000 | AP | 1991/11/01 | Approval |
|