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 |
021176 | 041 | AP | 2016/09/02 | Manufacturing Change or Addition |
021176 | 040 | AP | 2016/07/14 | Manufacturing Change or Addition |
021176 | 039 | AP | 2014/05/20 | Manufacturing Change or Addition |
021176 | 038 | AP | 2013/06/28 | Labeling Revision |
021176 | 037 | AP | 2014/01/22 | Efficacy Supplement with Clinical Data to Support |
021176 | 036 | AP | 2013/02/25 | Manufacturing Change or Addition |
021176 | 035 | AP | 2013/04/22 | Manufacturing Change or Addition |
021176 | 034 | AP | 2013/06/28 | Efficacy Supplement with Clinical Data to Support |
021176 | 030 | AP | 2012/07/09 | Labeling Revision |
021176 | 029 | AP | 2012/01/03 | Labeling Revision |
021176 | 028 | AP | 2011/07/18 | Labeling Revision |
021176 | 027 | AP | 2010/09/14 | Labeling Revision |
021176 | 022 | AP | 2009/10/02 | Patient Population Altered |
021176 | 021 | AP | 2008/05/30 | Manufacturing Change or Addition |
021176 | 019 | AP | 2007/08/27 | Labeling Revision |
021176 | 017 | AP | 2008/01/18 | New or Modified Indication |
021176 | 015 | AP | 2006/07/10 | Labeling Revision |
021176 | 014 | AP | 2006/09/06 | Efficacy Supplement with Clinical Data to Support |
021176 | 010 | AP | 2003/11/17 | Control Supplement |
021176 | 009 | AP | 2003/10/10 | Labeling Revision |
021176 | 008 | AP | 2003/08/21 | Control Supplement |
021176 | 006 | AP | 2002/08/08 | Control Supplement |
021176 | 005 | AP | 2002/10/17 | Package Change |
021176 | 004 | AP | 2003/02/11 | Labeling Revision |
021176 | 003 | AP | 2002/05/10 | Control Supplement |
021176 | 002 | AP | 2001/05/03 | Control Supplement |
021176 | 001 | AP | 2001/01/16 | Package Change |
021176 | 000 | AP | 2000/05/26 | Approval |