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 |
021743 | 027 | AP | 2016/06/01 | Efficacy Supplement with Clinical Data to Support |
021743 | 026 | AP | 2016/09/28 | Labeling Revision |
021743 | 025 | AP | 2016/10/18 | New or Modified Indication |
021743 | 024 | AP | 2016/03/15 | Manufacturing Change or Addition |
021743 | 023 | AP | 2016/05/20 | Efficacy Supplement with Clinical Data to Support |
021743 | 022 | AP | 2015/07/06 | Manufacturing Change or Addition |
021743 | 021 | AP | 2015/04/27 | Efficacy Supplement with Clinical Data to Support |
021743 | 019 | AP | 2014/04/14 | Labeling Revision |
021743 | 018 | AP | 2013/05/14 | New or Modified Indication |
021743 | 017 | AP | 2012/04/17 | Labeling Revision |
021743 | 016 | AP | 2010/04/16 | New or Modified Indication |
021743 | 015 | AP | 2009/04/27 | Labeling Revision |
021743 | 014 | AP | 2010/04/16 | Labeling Revision |
021743 | 011 | AP | 2008/09/19 | New Dosage Regimen |
021743 | 010 | AP | 2008/09/12 | Labeling Revision |
021743 | 008 | AP | 2008/09/12 | Labeling Revision |
021743 | 007 | AP | 2007/04/27 | Labeling Revision |
021743 | 003 | AP | 2005/11/02 | New or Modified Indication |
021743 | 000 | AP | 2004/11/18 | Approval |