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 |
019643 | 088 | AP | 2014/02/27 | Labeling Revision |
019643 | 087 | AP | 2012/10/31 | Labeling Revision |
019643 | 086 | AP | 2012/10/31 | Labeling Revision |
019643 | 085 | AP | 2012/02/28 | Labeling Revision |
019643 | 084 | AP | 2011/02/02 | Labeling Revision |
019643 | 082 | AP | 2011/06/10 | Labeling Revision |
019643 | 081 | AP | 2010/06/30 | Labeling Revision |
019643 | 080 | AP | 2009/03/09 | Control Supplement |
019643 | 079 | AP | 2007/12/07 | Manufacturing Change or Addition |
019643 | 078 | AP | 2007/05/29 | Labeling Revision |
019643 | 077 | AP | 2005/06/13 | Labeling Revision |
019643 | 076 | AP | 2005/11/04 | Labeling Revision |
019643 | 075 | AP | 2005/04/07 | Efficacy Supplement with Clinical Data to Support |
019643 | 073 | AP | 2003/10/17 | Supplement |
019643 | 071 | AP | 2002/09/20 | Labeling Revision |
019643 | 070 | AP | 2002/09/23 | Manufacturing Change or Addition |
019643 | 069 | AP | 2001/10/22 | Labeling Revision |
019643 | 068 | AP | 2002/01/30 | Control Supplement |
019643 | 067 | AP | 2002/02/14 | Patient Population Altered |
019643 | 066 | AP | 2001/06/26 | Manufacturing Change or Addition |
019643 | 065 | AP | 2001/08/01 | Control Supplement |
019643 | 064 | AP | 2001/04/26 | Labeling Revision |
019643 | 062 | AP | 2001/04/26 | Labeling Revision |
019643 | 061 | AP | 2007/04/17 | Labeling Revision |
019643 | 060 | AP | 2000/09/14 | Manufacturing Change or Addition |
019643 | 059 | AP | 2000/08/22 | Labeling Revision |
019643 | 057 | AP | 1999/03/01 | Labeling Revision |
019643 | 056 | AP | 1998/08/28 | Labeling Revision |
019643 | 055 | AP | 1999/03/11 | New or Modified Indication |
019643 | 054 | AP | 1998/06/29 | Labeling Revision |
019643 | 053 | AP | 1998/04/22 | Labeling Revision |
019643 | 052 | AP | 1997/11/20 | Package Change |
019643 | 051 | AP | 1997/06/25 | Control Supplement |
019643 | 050 | AP | 1997/08/12 | Labeling Revision |
019643 | 048 | AP | 1997/03/27 | Manufacturing Change or Addition |
019643 | 047 | AP | 1997/02/06 | Labeling Revision |
019643 | 046 | AP | 1996/12/26 | Control Supplement |
019643 | 045 | AP | 1996/04/30 | Control Supplement |
019643 | 044 | AP | 1995/08/08 | Labeling Revision |
019643 | 043 | AP | 1995/08/08 | Control Supplement |
019643 | 042 | AP | 1995/05/03 | New Dosage Regimen |
019643 | 041 | AP | 1995/01/23 | Labeling Revision |
019643 | 040 | AP | 1996/02/09 | Labeling Revision |
019643 | 039 | AP | 1995/08/01 | Manufacturing Change or Addition |
019643 | 037 | AP | 1994/12/21 | Labeling Revision |
019643 | 036 | AP | 1994/07/05 | Labeling Revision |
019643 | 035 | AP | 1994/12/20 | Control Supplement |
019643 | 034 | AP | 1995/02/08 | New or Modified Indication |
019643 | 033 | AP | 1994/05/17 | Labeling Revision |
019643 | 032 | AP | 1994/05/17 | Labeling Revision |
019643 | 031 | AP | 1993/08/09 | Package Change |
019643 | 030 | AP | 1992/11/27 | Labeling Revision |
019643 | 028 | AP | 1993/11/23 | Labeling Revision |
019643 | 027 | AP | 1993/11/24 | Labeling Revision |
019643 | 025 | AP | 1992/12/17 | Package Change |
019643 | 024 | AP | 1992/04/15 | Control Supplement |
019643 | 023 | AP | 1991/11/27 | Formulation Revision |
019643 | 021 | AP | 1993/11/22 | Labeling Revision |
019643 | 020 | AP | 1991/10/24 | Labeling Revision |
019643 | 018 | AP | 1991/03/28 | New Dosage Regimen |
019643 | 017 | AP | 1991/12/19 | Labeling Revision |
019643 | 015 | AP | 1991/04/10 | Labeling Revision |
019643 | 013 | AP | 1991/03/12 | Control Supplement |
019643 | 012 | AP | 1991/08/28 | Labeling Revision |
019643 | 011 | AP | 1989/10/20 | Labeling Revision |
019643 | 010 | AP | 1991/02/21 | Labeling Revision |
019643 | 009 | AP | 1988/12/14 | Labeling Revision |
019643 | 008 | AP | 1988/12/20 | Labeling Revision |
019643 | 007 | AP | 1989/03/21 | Labeling Revision |
019643 | 005 | AP | 1988/11/22 | Package Change |
019643 | 004 | AP | 1988/03/03 | Labeling Revision |
019643 | 003 | AP | 1988/07/06 | Manufacturing Change or Addition |
019643 | 001 | AP | 1988/03/01 | Labeling Revision |
019643 | 000 | AP | 1987/08/31 | Approval |