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 |
019810 | 103 | AP | 2016/10/24 | Labeling Revision |
019810 | 101 | AP | 2014/12/19 | Labeling Revision |
019810 | 099 | AP | 2014/02/25 | Labeling Revision |
019810 | 098 | AP | 2014/03/27 | Labeling Revision |
019810 | 097 | AP | 2013/05/15 | Labeling Revision |
019810 | 096 | AP | 2012/09/28 | Labeling Revision |
019810 | 095 | AP | 2012/10/09 | Labeling Revision |
019810 | 094 | AP | 2012/01/20 | Labeling Revision |
019810 | 093 | AP | 2011/05/20 | Labeling Revision |
019810 | 092 | AP | 2011/01/20 | Labeling Revision |
019810 | 091 | AP | 2011/06/30 | Labeling Revision |
019810 | 090 | AP | 2010/09/03 | Labeling Revision |
019810 | 088 | AP | 2010/03/03 | Labeling Revision |
019810 | 087 | AP | 2008/12/01 | Labeling Revision |
019810 | 085 | AP | 2007/04/27 | Labeling Revision |
019810 | 084 | AP | 2006/09/25 | Labeling Revision |
019810 | 083 | AP | 2006/01/26 | Labeling Revision |
019810 | 082 | AP | 2005/03/07 | Labeling Revision |
019810 | 080 | AP | 2003/10/09 | Labeling Revision |
019810 | 077 | AP | 2002/12/19 | Control Supplement |
019810 | 076 | AP | 2002/12/16 | Labeling Revision |
019810 | 075 | AP | 2001/05/10 | Package Change |
019810 | 074 | AP | 2002/07/12 | Patient Population Altered |
019810 | 073 | AP | 2001/10/30 | Labeling Revision |
019810 | 072 | AP | 2000/08/10 | Control Supplement |
019810 | 071 | AP | 2002/02/04 | Package Change |
019810 | 070 | AP | 2000/07/27 | Expiration Date Change |
019810 | 069 | AP | 2000/07/27 | Control Supplement |
019810 | 068 | AP | 2000/03/13 | Control Supplement |
019810 | 067 | AP | 2003/10/09 | Labeling Revision |
019810 | 066 | AP | 2001/05/16 | Package Change |
019810 | 065 | AP | 1999/11/10 | Manufacturing Change or Addition |
019810 | 064 | AP | 2000/03/16 | Manufacturing Change or Addition |
019810 | 063 | AP | 2000/08/08 | Manufacturing Change or Addition |
019810 | 062 | AP | 2000/02/23 | Labeling Revision |
019810 | 061 | AP | 2002/02/14 | Efficacy Supplement with Clinical Data to Support |
019810 | 060 | AP | 1999/05/18 | Control Supplement |
019810 | 059 | AP | 2000/03/13 | Expiration Date Change |
019810 | 058 | AP | 2004/02/23 | Efficacy Supplement with Clinical Data to Support |
019810 | 057 | AP | 1999/02/03 | Labeling Revision |
019810 | 056 | AP | 1998/07/10 | Package Change |
019810 | 055 | AP | 1998/06/30 | Efficacy Supplement with Clinical Data to Support |
019810 | 054 | AP | 1998/12/01 | Control Supplement |
019810 | 053 | AP | 1998/08/17 | Package Change |
019810 | 052 | AP | 1998/07/30 | Manufacturing Change or Addition |
019810 | 051 | AP | 1997/06/17 | Control Supplement |
019810 | 050 | AP | 1998/01/07 | Package Change |
019810 | 049 | AP | 1997/09/03 | Manufacturing Change or Addition |
019810 | 048 | AP | 1997/04/15 | Labeling Revision |
019810 | 045 | AP | 1999/02/18 | Control Supplement |
019810 | 043 | AP | 1997/04/04 | Manufacturing Change or Addition |
019810 | 042 | AP | 1997/04/18 | Manufacturing Change or Addition |
019810 | 041 | AP | 1996/08/09 | Labeling Revision |
019810 | 039 | AP | 1996/09/11 | Control Supplement |
019810 | 038 | AP | 1998/01/15 | Formulation Revision |
019810 | 037 | AP | 1996/04/15 | New or Modified Indication |
019810 | 036 | AP | 1996/11/26 | New or Modified Indication |
019810 | 035 | AP | 1995/03/09 | Labeling Revision |
019810 | 034 | AP | 1995/11/09 | Manufacturing Change or Addition |
019810 | 033 | AP | 1996/03/22 | New or Modified Indication |
019810 | 032 | AP | 1995/03/23 | Control Supplement |
019810 | 031 | AP | 1995/03/23 | Manufacturing Change or Addition |
019810 | 030 | AP | 1995/01/31 | Manufacturing Change or Addition |
019810 | 029 | AP | 1995/01/27 | Control Supplement |
019810 | 028 | AP | 1995/01/20 | Formulation Revision |
019810 | 026 | AP | 1994/12/29 | Package Change |
019810 | 025 | AP | 1995/10/19 | Package Change |
019810 | 024 | AP | 1995/06/16 | Labeling Revision |
019810 | 023 | AP | 1995/10/05 | Formulation Revision |
019810 | 022 | AP | 1995/03/09 | Labeling Revision |
019810 | 021 | AP | 1993/12/22 | Package Change |
019810 | 020 | AP | 1994/10/13 | Manufacturing Change or Addition |
019810 | 019 | AP | 1995/06/22 | New or Modified Indication |
019810 | 018 | AP | 1997/11/04 | Labeling Revision |
019810 | 016 | AP | 1993/06/29 | Package Change |
019810 | 015 | AP | 1993/06/15 | Manufacturing Change or Addition |
019810 | 014 | AP | 1992/10/21 | Package Change |
019810 | 013 | AP | 1993/03/19 | Control Supplement |
019810 | 012 | AP | 1993/05/26 | Manufacturing Change or Addition |
019810 | 010 | AP | 1995/03/09 | Labeling Revision |
019810 | 009 | AP | 1995/03/09 | Labeling Revision |
019810 | 008 | AP | 1992/01/27 | Manufacturing Change or Addition |
019810 | 007 | AP | 1991/01/03 | Labeling Revision |
019810 | 006 | AP | 1990/07/19 | Labeling Revision |
019810 | 005 | AP | 1992/09/14 | Manufacturing Change or Addition |
019810 | 003 | AP | 2004/02/23 | Labeling Revision |
019810 | 002 | AP | 1991/06/12 | New or Modified Indication |
019810 | 001 | AP | 1989/10/26 | Labeling Revision |
019810 | 000 | AP | 1989/09/14 | Approval |