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 |
019766 | 095 | AP | 2016/03/01 | Manufacturing Change or Addition |
019766 | 093 | AP | 2015/02/02 | Labeling Revision |
019766 | 091 | AP | 2014/02/27 | Labeling Revision |
019766 | 090 | AP | 2013/10/25 | Labeling Revision |
019766 | 088 | AP | 2012/10/31 | Labeling Revision |
019766 | 087 | AP | 2012/10/31 | Labeling Revision |
019766 | 086 | AP | 2012/11/15 | Manufacturing Change or Addition |
019766 | 085 | AP | 2012/02/28 | Labeling Revision |
019766 | 083 | AP | 2011/10/06 | Labeling Revision |
019766 | 082 | AP | 2011/06/08 | Labeling Revision |
019766 | 081 | AP | 2010/11/04 | Labeling Revision |
019766 | 080 | AP | 2010/04/08 | Labeling Revision |
019766 | 079 | AP | 2011/06/10 | Labeling Revision |
019766 | 078 | AP | 2010/03/02 | Labeling Revision |
019766 | 077 | AP | 2011/06/08 | Labeling Revision |
019766 | 076 | AP | 2008/06/11 | Labeling Revision |
019766 | 075 | AP | 2007/11/26 | Labeling Revision |
019766 | 074 | AP | 2007/06/01 | Control Supplement |
019766 | 070 | AP | 2005/05/17 | Labeling Revision |
019766 | 069 | AP | 2005/08/31 | Labeling Revision |
019766 | 068 | AP | 2004/02/25 | Supplement |
019766 | 067 | AP | 2004/02/24 | Labeling Revision |
019766 | 066 | AP | 2003/09/17 | Labeling Revision |
019766 | 065 | AP | 2003/09/17 | Labeling Revision |
019766 | 058 | AP | 2003/04/16 | New or Modified Indication |
019766 | 057 | AP | 2002/05/06 | Control Supplement |
019766 | 056 | AP | 2002/10/18 | Patient Population Altered |
019766 | 055 | AP | 2002/02/22 | Manufacturing Change or Addition |
019766 | 054 | AP | 2002/03/21 | Package Change |
019766 | 053 | AP | 2001/11/14 | Labeling Revision |
019766 | 052 | AP | 2002/03/21 | Efficacy Supplement with Clinical Data to Support |
019766 | 051 | AP | 2002/05/06 | Labeling Revision |
019766 | 050 | AP | 2001/09/13 | Control Supplement |
019766 | 049 | AP | 2001/06/04 | Control Supplement |
019766 | 048 | AP | 2001/04/10 | Manufacturing Change or Addition |
019766 | 047 | AP | 2001/04/10 | Manufacturing Change or Addition |
019766 | 045 | AP | 2001/11/14 | Labeling Revision |
019766 | 044 | AP | 2000/12/11 | Package Change |
019766 | 043 | AP | 2000/04/14 | Manufacturing Change or Addition |
019766 | 042 | AP | 2000/11/07 | Efficacy Supplement with Clinical Data to Support |
019766 | 041 | AP | 2000/03/15 | Control Supplement |
019766 | 040 | AP | 2000/04/27 | New Dosage Regimen |
019766 | 039 | AP | 2000/08/22 | Labeling Revision |
019766 | 036 | AP | 1999/11/22 | New or Modified Indication |
019766 | 035 | AP | 1999/09/15 | Labeling Revision |
019766 | 034 | AP | 1999/11/22 | New or Modified Indication |
019766 | 033 | AP | 1999/03/22 | Expiration Date Change |
019766 | 032 | AP | 1999/08/05 | New or Modified Indication |
019766 | 031 | AP | 1999/04/23 | Labeling Revision |
019766 | 030 | AP | 1998/09/24 | Manufacturing Change or Addition |
019766 | 029 | AP | 1998/06/29 | Labeling Revision |
019766 | 028 | AP | 1998/07/10 | New Dosage Regimen |
019766 | 027 | AP | 1998/03/31 | New or Modified Indication |
019766 | 026 | AP | 1998/07/10 | New or Modified Indication |
019766 | 025 | AP | 1997/12/02 | Control Supplement |
019766 | 023 | AP | 1997/09/09 | Control Supplement |
019766 | 022 | AP | 1997/07/18 | Manufacturing Change or Addition |
019766 | 021 | AP | 1997/10/31 | New or Modified Indication |
019766 | 020 | AP | 1997/08/12 | Labeling Revision |
019766 | 019 | AP | 1997/03/17 | Control Supplement |
019766 | 018 | AP | 1997/05/19 | Labeling Revision |
019766 | 017 | AP | 1997/05/23 | Labeling Revision |
019766 | 016 | AP | 1996/11/22 | Control Supplement |
019766 | 015 | AP | 1995/08/01 | Labeling Revision |
019766 | 014 | AP | 1995/06/09 | Labeling Revision |
019766 | 013 | AP | 1995/11/06 | Control Supplement |
019766 | 012 | AP | 1995/08/01 | Control Supplement |
019766 | 011 | AP | 1995/06/30 | New or Modified Indication |
019766 | 010 | AP | 1995/02/16 | Labeling Revision |
019766 | 009 | AP | 1994/12/21 | Labeling Revision |
019766 | 008 | AP | 1995/04/19 | Labeling Revision |
019766 | 007 | AP | 1994/07/28 | Manufacturing Change or Addition |
019766 | 006 | AP | 1995/01/23 | Labeling Revision |
019766 | 005 | AP | 1994/02/22 | Labeling Revision |
019766 | 004 | AP | 1993/11/24 | Package Change |
019766 | 003 | AP | 1994/02/22 | Labeling Revision |
019766 | 002 | AP | 1993/08/09 | Package Change |
019766 | 001 | AP | 1992/11/27 | Labeling Revision |
019766 | 000 | AP | 1991/12/23 | Approval |