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 |
019857 | 065 | AP | 2016/07/26 | Labeling Revision |
019857 | 064 | AP | 2015/03/19 | Labeling Revision |
019857 | 063 | AP | 2015/02/02 | Efficacy Supplement with Clinical Data to Support |
019857 | 062 | AP | 2013/08/14 | Labeling Revision |
019857 | 061 | AP | 2013/10/14 | Manufacturing Change or Addition |
019857 | 060 | AP | 2013/01/30 | Labeling Revision |
019857 | 059 | AP | 2011/10/18 | Labeling Revision |
019857 | 058 | AP | 2011/08/03 | Labeling Revision |
019857 | 057 | AP | 2011/08/12 | Labeling Revision |
019857 | 054 | AP | 2011/02/25 | Labeling Revision |
019857 | 053 | AP | 2011/11/15 | Labeling Revision |
019857 | 052 | AP | 2009/06/24 | Labeling Revision |
019857 | 051 | AP | 2009/04/27 | Labeling Revision |
019857 | 050 | AP | 2009/02/13 | Labeling Revision |
019857 | 049 | AP | 2008/10/03 | Labeling Revision |
019857 | 048 | AP | 2008/01/18 | Labeling Revision |
019857 | 046 | AP | 2007/06/25 | Labeling Revision |
019857 | 042 | AP | 2006/06/19 | Labeling Revision |
019857 | 041 | AP | 2005/11/09 | Labeling Revision |
019857 | 038 | AP | 2005/05/18 | Labeling Revision |
019857 | 036 | AP | 2004/07/14 | Labeling Revision |
019857 | 035 | AP | 2005/01/07 | Accelerated Approval |
019857 | 034 | AP | 2004/07/14 | Labeling Revision |
019857 | 033 | AP | 2004/07/14 | Labeling Revision |
019857 | 031 | AP | 2004/03/25 | Patient Population Altered |
019857 | 029 | AP | 2002/12/10 | Manufacturing Change or Addition |
019857 | 028 | AP | 2002/04/17 | Labeling Revision |
019857 | 027 | AP | 2000/08/30 | New or Modified Indication |
019857 | 026 | AP | 1999/06/09 | Control Supplement |
019857 | 025 | AP | 2000/06/28 | Labeling Revision |
019857 | 024 | AP | 1998/09/24 | Labeling Revision |
019857 | 023 | AP | 1999/01/07 | Manufacturing Change or Addition |
019857 | 022 | AP | 1998/11/13 | Control Supplement |
019857 | 021 | AP | 1998/09/24 | New or Modified Indication |
019857 | 020 | AP | 1998/09/24 | Labeling Revision |
019857 | 019 | AP | 1998/09/24 | New or Modified Indication |
019857 | 018 | AP | 1997/08/15 | Manufacturing Change or Addition |
019857 | 017 | AP | 1997/08/07 | New or Modified Indication |
019857 | 016 | AP | 1996/08/09 | Labeling Revision |
019857 | 015 | AP | 1996/06/28 | Package Change |
019857 | 014 | AP | 1998/04/03 | Patient Population Altered |
019857 | 013 | AP | 1997/09/26 | Labeling Revision |
019857 | 011 | AP | 1996/10/10 | New or Modified Indication |
019857 | 010 | AP | 1994/04/28 | Control Supplement |
019857 | 009 | AP | 1993/12/27 | Control Supplement |
019857 | 008 | AP | 1996/10/21 | New or Modified Indication |
019857 | 006 | AP | 1995/10/25 | Labeling Revision |
019857 | 005 | AP | 1992/04/23 | Control Supplement |
019857 | 003 | AP | 1992/05/13 | Control Supplement |
019857 | 002 | AP | 1991/04/24 | Package Change |
019857 | 001 | AP | 1991/04/24 | Package Change |
019857 | 000 | AP | 1990/12/26 | Approval |