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 |
020839 | 064 | AP | 2016/09/16 | Labeling Revision |
020839 | 063 | AP | 2016/03/24 | Manufacturing Change or Addition |
020839 | 062 | AP | 2016/09/16 | Labeling Revision |
020839 | 061 | AP | 2015/07/16 | Labeling Revision |
020839 | 060 | AP | 2014/05/14 | Manufacturing Change or Addition |
020839 | 059 | AP | 2014/03/12 | Manufacturing Change or Addition |
020839 | 058 | AP | 2013/12/12 | Labeling Revision |
020839 | 057 | AP | 2013/09/12 | Labeling Revision |
020839 | 056 | AP | 2013/05/24 | Manufacturing Change or Addition |
020839 | 055 | AP | 2011/12/20 | Labeling Revision |
020839 | 053 | AP | 2011/05/03 | Labeling Revision |
020839 | 052 | AP | 2011/02/01 | Labeling Revision |
020839 | 051 | AP | 2011/05/06 | Efficacy Supplement with Clinical Data to Support |
020839 | 048 | AP | 2010/08/24 | Labeling Revision |
020839 | 044 | AP | 2009/11/12 | Labeling Revision |
020839 | 042 | AP | 2010/03/12 | Labeling Revision |
020839 | 040 | AP | 2009/05/05 | Labeling Revision |
020839 | 038 | AP | 2007/09/20 | Formulation Revision |
020839 | 037 | AP | 2007/05/01 | Labeling Revision |
020839 | 035 | AP | 2006/08/04 | Labeling Revision |
020839 | 034 | AP | 2006/08/17 | New or Modified Indication |
020839 | 033 | AP | 2005/10/14 | Labeling Revision |
020839 | 031 | AP | 2005/04/25 | Labeling Revision |
020839 | 030 | AP | 2005/04/25 | Labeling Revision |
020839 | 028 | AP | 2005/04/26 | Labeling Revision |
020839 | 024 | AP | 2003/09/29 | Labeling Revision |
020839 | 023 | AP | 2004/10/13 | Labeling Revision |
020839 | 022 | AP | 2002/06/10 | Manufacturing Change or Addition |
020839 | 021 | AP | 2003/09/29 | Labeling Revision |
020839 | 020 | AP | 2002/09/10 | Expiration Date Change |
020839 | 019 | AP | 2002/02/27 | New or Modified Indication |
020839 | 018 | AP | 2002/01/28 | Labeling Revision |
020839 | 017 | AP | 2001/12/05 | Manufacturing Change or Addition |
020839 | 016 | AP | 2001/07/19 | Manufacturing Change or Addition |
020839 | 015 | AP | 2001/06/18 | Control Supplement |
020839 | 014 | AP | 2001/03/07 | Manufacturing Change or Addition |
020839 | 013 | AP | 2001/03/07 | Manufacturing Change or Addition |
020839 | 011 | AP | 2000/10/24 | Manufacturing Change or Addition |
020839 | 010 | AP | 2000/11/09 | Manufacturing Change or Addition |
020839 | 009 | AP | 2000/07/25 | Formulation Revision |
020839 | 008 | AP | 2000/04/28 | Labeling Revision |
020839 | 007 | AP | 2000/07/10 | Manufacturing Change or Addition |
020839 | 006 | AP | 2000/02/22 | Labeling Revision |
020839 | 005 | AP | 2000/03/15 | Control Supplement |
020839 | 004 | AP | 2000/01/27 | Manufacturing Change or Addition |
020839 | 003 | AP | 1999/08/20 | Control Supplement |
020839 | 002 | AP | 1998/05/21 | Manufacturing Change or Addition |
020839 | 001 | AP | 1998/05/12 | Expiration Date Change |
020839 | 000 | AP | 1997/11/17 | Approval |