药品名称 | CERVIDIL | 申请号 | 020411 | 产品号 | 001 | 活性成分 | DINOPROSTONE | 市场状态 | 处方药 | 剂型或给药途径 | INSERT, EXTENDED RELEASE;VAGINAL | 规格 | 10MG | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1995/03/30 | 申请机构 | FERRING PHARMACEUTICALS INC
| 化学类型 | New dosage form | 审评分类 | Standard review drug |
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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 |
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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 | 020411 | 027 | AP | Label | 2010/05/28 | 下载 | 020411 | 027 | AP | Letter | 2010/06/02 | 下载 | 020411 | 023 | AP | Letter | 2006/12/04 | 下载 | 020411 | 023 | AP | Label | 2006/12/04 | 下载 |
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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 | 020411 | 027 | AP | 2010/05/26 | Labeling Revision | 020411 | 023 | AP | 2006/11/28 | Labeling Revision | 020411 | 020 | AP | 2002/01/25 | Control Supplement | 020411 | 019 | AP | 2001/12/21 | Control Supplement | 020411 | 017 | AP | 2000/11/06 | Control Supplement | 020411 | 016 | AP | 2000/04/13 | Labeling Revision | 020411 | 015 | AP | 2000/06/30 | Manufacturing Change or Addition | 020411 | 014 | AP | 2000/02/11 | Labeling Revision | 020411 | 013 | AP | 2000/06/27 | Control Supplement | 020411 | 011 | AP | 1999/11/05 | Labeling Revision | 020411 | 010 | AP | 1999/08/31 | Package Change | 020411 | 009 | AP | 1999/03/19 | Manufacturing Change or Addition | 020411 | 008 | AP | 1999/02/24 | Control Supplement | 020411 | 007 | AP | 1998/02/03 | Control Supplement | 020411 | 006 | AP | 1997/12/24 | Control Supplement | 020411 | 005 | AP | 1999/08/24 | Control Supplement | 020411 | 004 | AP | 1997/12/18 | Manufacturing Change or Addition | 020411 | 003 | AP | 1996/04/04 | Manufacturing Change or Addition | 020411 | 002 | AP | 1995/08/29 | Control Supplement | 020411 | 001 | AP | 1996/02/22 | Labeling Revision | 020411 | 000 | AP | 1995/03/30 | Approval |
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