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 |
020986 | 084 | AP | 2016/10/07 | Labeling Revision |
020986 | 082 | AP | 2015/04/17 | Labeling Revision |
020986 | 081 | AP | 2015/02/25 | Labeling Revision |
020986 | 080 | AP | 2015/01/23 | Labeling Revision |
020986 | 078 | AP | 2015/01/14 | Efficacy Supplement with Clinical Data to Support |
020986 | 077 | AP | 2014/09/04 | Manufacturing Change or Addition |
020986 | 076 | AP | 2014/09/04 | Manufacturing Change or Addition |
020986 | 075 | AP | 2014/02/25 | Labeling Revision |
020986 | 074 | AP | 2014/03/04 | Manufacturing Change or Addition |
020986 | 067 | AP | 2013/03/09 | Labeling Revision |
020986 | 064 | AP | 2012/12/13 | Labeling Revision |
020986 | 062 | AP | 2012/11/28 | Labeling Revision |
020986 | 061 | AP | 2013/10/31 | Labeling Revision |
020986 | 060 | AP | 2010/06/25 | Labeling Revision |
020986 | 059 | AP | 2015/02/25 | Labeling Revision |
020986 | 058 | AP | 2010/06/25 | Manufacturing Change or Addition |
020986 | 057 | AP | 2012/11/05 | Labeling Revision |
020986 | 055 | AP | 2009/07/17 | Control Supplement |
020986 | 054 | AP | 2009/05/07 | Labeling Revision |
020986 | 053 | AP | 2008/11/28 | Labeling Revision |
020986 | 050 | AP | 2008/09/03 | Labeling Revision |
020986 | 049 | AP | 2008/09/03 | Labeling Revision |
020986 | 047 | AP | 2008/03/14 | Patient Population Altered |
020986 | 045 | AP | 2009/07/14 | Expiration Date Change |
020986 | 040 | AP | 2006/10/27 | Manufacturing Change or Addition |
020986 | 037 | AP | 2007/01/26 | Efficacy Supplement with Clinical Data to Support |
020986 | 033 | AP | 2005/09/13 | Patient Population Altered |
020986 | 032 | AP | 2005/10/21 | Supplement |
020986 | 024 | AP | 2004/07/30 | Labeling Revision |
020986 | 023 | AP | 2004/04/23 | Package Change |
020986 | 020 | AP | 2004/03/19 | Labeling Revision |
020986 | 019 | AP | 2004/10/08 | Labeling Revision |
020986 | 016 | AP | 2002/12/04 | Control Supplement |
020986 | 015 | AP | 2002/11/19 | Control Supplement |
020986 | 011 | AP | 2002/12/04 | Efficacy Supplement with Clinical Data to Support |
020986 | 010 | AP | 2002/07/29 | Control Supplement |
020986 | 009 | AP | 2002/03/05 | Control Supplement |
020986 | 008 | AP | 2001/11/20 | Manufacturing Change or Addition |
020986 | 007 | AP | 2001/07/27 | Manufacturing Change or Addition |
020986 | 006 | AP | 2001/08/31 | Control Supplement |
020986 | 005 | AP | 2001/06/26 | Manufacturing Change or Addition |
020986 | 004 | AP | 2002/04/11 | Package Change |
020986 | 003 | AP | 2001/12/21 | New Route of Administration |
020986 | 002 | AP | 2002/04/11 | Package Change |
020986 | 001 | AP | 2001/01/19 | Control Supplement |
020986 | 000 | AP | 2000/06/07 | Approval |