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 |
019758 | 079 | AP | 2016/05/06 | Manufacturing Change or Addition |
019758 | 078 | AP | 2015/10/08 | Labeling Revision |
019758 | 077 | AP | 2015/09/15 | Labeling Revision |
019758 | 076 | AP | 2015/11/10 | Manufacturing Change or Addition |
019758 | 074 | AP | 2015/09/18 | Labeling Revision |
019758 | 073 | AP | 2014/12/19 | Labeling Revision |
019758 | 072 | AP | 2014/09/29 | Labeling Revision |
019758 | 071 | AP | 2013/07/19 | Labeling Revision |
019758 | 070 | AP | 2013/03/22 | Labeling Revision |
019758 | 069 | AP | 2013/07/19 | Labeling Revision |
019758 | 068 | AP | 2013/03/22 | Labeling Revision |
019758 | 067 | AP | 2013/03/22 | Labeling Revision |
019758 | 065 | AP | 2010/12/01 | Labeling Revision |
019758 | 064 | AP | 2014/09/30 | Manufacturing Change or Addition |
019758 | 063 | AP | 2011/10/19 | Labeling Revision |
019758 | 062 | AP | 2010/01/14 | Labeling Revision |
019758 | 061 | AP | 2015/09/15 | Efficacy Supplement with Clinical Data to Support |
019758 | 059 | AP | 2008/08/14 | Labeling Revision |
019758 | 058 | AP | 2008/06/26 | Labeling Revision |
019758 | 057 | AP | 2005/12/05 | Labeling Revision |
019758 | 056 | AP | 2005/06/29 | Labeling Revision |
019758 | 054 | AP | 2005/05/12 | Labeling Revision |
019758 | 053 | AP | 2008/11/06 | Labeling Revision |
019758 | 051 | AP | 2003/12/23 | Labeling Revision |
019758 | 048 | AP | 2002/07/05 | Labeling Revision |
019758 | 047 | AP | 2002/12/18 | New or Modified Indication |
019758 | 046 | AP | 2001/12/14 | Manufacturing Change or Addition |
019758 | 045 | AP | 2002/01/14 | Labeling Revision |
019758 | 044 | AP | 2001/08/29 | Labeling Revision |
019758 | 043 | AP | 2001/05/18 | Control Supplement |
019758 | 042 | AP | 2000/05/17 | Manufacturing Change or Addition |
019758 | 041 | AP | 2000/03/17 | Labeling Revision |
019758 | 040 | AP | 1999/10/15 | Control Supplement |
019758 | 039 | AP | 1999/11/01 | Manufacturing Change or Addition |
019758 | 038 | AP | 1999/04/15 | Package Change |
019758 | 037 | AP | 1999/08/09 | Package Change |
019758 | 036 | AP | 1998/08/19 | Labeling Revision |
019758 | 035 | AP | 1997/09/19 | Labeling Revision |
019758 | 034 | AP | 1998/03/03 | Labeling Revision |
019758 | 033 | AP | 1997/04/25 | Labeling Revision |
019758 | 032 | AP | 1997/06/27 | Labeling Revision |
019758 | 031 | AP | 1997/01/13 | Control Supplement |
019758 | 030 | AP | 1996/05/07 | Control Supplement |
019758 | 029 | AP | 1995/11/22 | Manufacturing Change or Addition |
019758 | 027 | AP | 1997/04/25 | Labeling Revision |
019758 | 026 | AP | 1995/10/17 | Control Supplement |
019758 | 025 | AP | 1997/04/25 | Labeling Revision |
019758 | 024 | AP | 1995/05/10 | Manufacturing Change or Addition |
019758 | 023 | AP | 1997/04/25 | Labeling Revision |
019758 | 022 | AP | 1994/08/30 | Labeling Revision |
019758 | 021 | AP | 1994/05/20 | Labeling Revision |
019758 | 020 | AP | 1994/07/15 | Control Supplement |
019758 | 019 | AP | 1995/03/07 | Control Supplement |
019758 | 017 | AP | 1994/08/05 | Control Supplement |
019758 | 016 | AP | 1995/08/31 | Labeling Revision |
019758 | 015 | AP | 1995/08/31 | Formulation Revision |
019758 | 014 | AP | 1992/08/20 | Labeling Revision |
019758 | 013 | AP | 1994/08/01 | Package Change |
019758 | 012 | AP | 1994/03/25 | Control Supplement |
019758 | 011 | AP | 1992/08/10 | Labeling Revision |
019758 | 010 | AP | 1992/10/27 | Labeling Revision |
019758 | 009 | AP | 1991/09/04 | Control Supplement |
019758 | 008 | AP | 1991/06/12 | Labeling Revision |
019758 | 006 | AP | 1991/06/12 | Labeling Revision |
019758 | 005 | AP | 1991/06/12 | Labeling Revision |
019758 | 004 | AP | 1994/03/25 | Package Change |
019758 | 003 | AP | 1994/03/25 | Package Change |
019758 | 002 | AP | 1991/06/12 | Labeling Revision |
019758 | 001 | AP | 1990/02/05 | Labeling Revision |
019758 | 000 | AP | 1989/09/26 | Approval |