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 |
020406 | 082 | AP | 2016/10/24 | Labeling Revision |
020406 | 081 | AP | 2014/12/19 | Labeling Revision |
020406 | 080 | AP | 2015/12/16 | Labeling Revision |
020406 | 079 | AP | 2012/05/03 | Labeling Revision |
020406 | 078 | AP | 2012/09/28 | Labeling Revision |
020406 | 077 | AP | 2011/05/20 | Labeling Revision |
020406 | 076 | AP | 2011/10/28 | Labeling Revision |
020406 | 075 | AP | 2011/06/01 | Labeling Revision |
020406 | 074 | AP | 2010/09/03 | Labeling Revision |
020406 | 073 | AP | 2010/05/12 | Labeling Revision |
020406 | 071 | AP | 2009/07/31 | Labeling Revision |
020406 | 067 | AP | 2008/10/28 | Labeling Revision |
020406 | 065 | AP | 2008/04/21 | Labeling Revision |
020406 | 064 | AP | 2007/06/14 | Labeling Revision |
020406 | 058 | AP | 2006/04/12 | Labeling Revision |
020406 | 057 | AP | 2004/06/17 | Patient Population Altered |
020406 | 056 | AP | 2004/06/15 | Labeling Revision |
020406 | 055 | AP | 2003/08/05 | Labeling Revision |
020406 | 052 | AP | 2002/08/30 | Labeling Revision |
020406 | 048 | AP | 2002/12/03 | Labeling Revision |
020406 | 047 | AP | 2002/07/31 | Patient Population Altered |
020406 | 046 | AP | 2002/03/07 | Control Supplement |
020406 | 045 | AP | 2002/05/03 | Labeling Revision |
020406 | 044 | AP | 2001/12/05 | Manufacturing Change or Addition |
020406 | 043 | AP | 2001/04/11 | Package Change |
020406 | 042 | AP | 2000/12/08 | Control Supplement |
020406 | 041 | AP | 2001/06/29 | Package Change |
020406 | 040 | AP | 2001/05/07 | Manufacturing Change or Addition |
020406 | 039 | AP | 2000/10/30 | Package Change |
020406 | 038 | AP | 2001/05/01 | Efficacy Supplement with Clinical Data to Support |
020406 | 036 | AP | 1999/11/15 | Control Supplement |
020406 | 035 | AP | 2000/06/02 | Manufacturing Change or Addition |
020406 | 034 | AP | 2000/06/20 | Labeling Revision |
020406 | 033 | AP | 2000/11/30 | New or Modified Indication |
020406 | 032 | AP | 1999/11/15 | Manufacturing Change or Addition |
020406 | 030 | AP | 1999/02/22 | Labeling Revision |
020406 | 029 | AP | 1998/11/20 | Control Supplement |
020406 | 028 | AP | 1999/07/06 | Comparative Efficacy Claim |
020406 | 027 | AP | 1999/01/14 | Labeling Revision |
020406 | 026 | AP | 1998/03/19 | Package Change |
020406 | 025 | AP | 1998/07/27 | Package Change |
020406 | 024 | AP | 1998/06/23 | Labeling Revision |
020406 | 023 | AP | 1998/06/11 | Package Change |
020406 | 022 | AP | 1998/07/20 | Labeling Revision |
020406 | 021 | AP | 1998/07/20 | New Dosage Regimen |
020406 | 020 | AP | 1997/09/04 | Manufacturing Change or Addition |
020406 | 019 | AP | 1997/09/17 | Manufacturing Change or Addition |
020406 | 018 | AP | 1997/06/23 | Labeling Revision |
020406 | 017 | AP | 1997/09/17 | Manufacturing Change or Addition |
020406 | 016 | AP | 1998/03/12 | New or Modified Indication |
020406 | 015 | AP | 1997/06/17 | Labeling Revision |
020406 | 013 | AP | 1997/06/17 | Labeling Revision |
020406 | 012 | AP | 1996/12/24 | Labeling Revision |
020406 | 011 | AP | 1997/05/08 | New or Modified Indication |
020406 | 010 | AP | 1997/04/17 | New or Modified Indication |
020406 | 009 | AP | 1997/02/25 | Labeling Revision |
020406 | 008 | AP | 1996/09/13 | Package Change |
020406 | 007 | AP | 1996/07/25 | Package Change |
020406 | 006 | AP | 1996/01/30 | Labeling Revision |
020406 | 005 | AP | 1996/05/06 | Package Change |
020406 | 004 | AP | 1995/10/18 | Labeling Revision |
020406 | 002 | AP | 1996/04/08 | New or Modified Indication |
020406 | 001 | AP | 1995/11/30 | Labeling Revision |
020406 | 000 | AP | 1995/05/10 | Approval |