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 |
021323 | 046 | AP | 2016/01/28 | Manufacturing Change or Addition |
021323 | 045 | AP | 2014/07/08 | Labeling Revision |
021323 | 044 | AP | 2014/10/31 | Labeling Revision |
021323 | 043 | AP | 2013/05/29 | Manufacturing Change or Addition |
021323 | 040 | AP | 2012/12/03 | Labeling Revision |
021323 | 039 | AP | 2013/03/07 | Manufacturing Change or Addition |
021323 | 035 | AP | 2011/03/11 | Labeling Revision |
021323 | 033 | AP | 2011/05/12 | Labeling Revision |
021323 | 032 | AP | 2009/01/30 | Labeling Revision |
021323 | 031 | AP | 2009/03/19 | Patient Population Altered |
021323 | 030 | AP | 2009/03/19 | Patient Population Altered |
021323 | 029 | AP | 2008/10/11 | Labeling Revision |
021323 | 028 | AP | 2008/09/17 | Labeling Revision |
021323 | 025 | AP | 2007/08/02 | Labeling Revision |
021323 | 020 | AP | 2005/02/18 | Labeling Revision |
021323 | 015 | AP | 2004/05/20 | Labeling Revision |
021323 | 014 | AP | 2005/01/11 | Labeling Revision |
021323 | 010 | AP | 2004/04/08 | Supplement |
021323 | 007 | AP | 2003/12/18 | Efficacy Supplement with Clinical Data to Support |
021323 | 003 | AP | 2003/12/18 | New or Modified Indication |
021323 | 002 | AP | 2002/12/13 | Manufacturing Change or Addition |
021323 | 001 | AP | 2002/08/29 | Efficacy Supplement with Clinical Data to Support |
021323 | 000 | AP | 2002/08/14 | Approval |