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 |
021752 | 050 | AP | 2016/02/25 | Labeling Revision |
021752 | 047 | AP | 2016/03/10 | Efficacy Supplement with Clinical Data to Support |
021752 | 045 | AP | 2014/07/11 | Manufacturing Change or Addition |
021752 | 044 | AP | 2014/06/18 | Labeling Revision |
021752 | 043 | AP | 2013/12/16 | Labeling Revision |
021752 | 042 | AP | 2013/10/23 | Labeling Revision |
021752 | 040 | AP | 2013/11/08 | Manufacturing Change or Addition |
021752 | 039 | AP | 2013/07/08 | Manufacturing Change or Addition |
021752 | 038 | AP | 2013/08/21 | Manufacturing Change or Addition |
021752 | 037 | AP | 2013/08/15 | Manufacturing Change or Addition |
021752 | 036 | AP | 2013/06/17 | Manufacturing Change or Addition |
021752 | 035 | AP | 2013/06/17 | Labeling Revision |
021752 | 033 | AP | 2013/11/27 | Manufacturing Change or Addition |
021752 | 031 | AP | 2012/07/16 | Labeling Revision |
021752 | 030 | AP | 2012/07/16 | New or Modified Indication |
021752 | 027 | AP | 2011/07/08 | Labeling Revision |
021752 | 021 | AP | 2010/01/15 | Manufacturing Change or Addition |
021752 | 019 | AP | 2009/11/06 | Labeling Revision |
021752 | 017 | AP | 2008/11/04 | Labeling Revision |
021752 | 016 | AP | 2008/05/16 | Efficacy Supplement with Clinical Data to Support |
021752 | 011 | AP | 2007/05/21 | Labeling Revision |
021752 | 006 | AP | 2005/10/05 | Labeling Revision |
021752 | 005 | AP | 2006/03/08 | Accelerated Approval |
021752 | 002 | AP | 2005/03/25 | Labeling Revision |
021752 | 000 | AP | 2004/08/02 | Approval |