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 |
020634 | 067 | AP | 2016/07/26 | Labeling Revision |
020634 | 066 | AP | 2014/05/23 | Labeling Revision |
020634 | 065 | AP | 2013/08/14 | Labeling Revision |
020634 | 064 | AP | 2011/10/11 | Labeling Revision |
020634 | 062 | AP | 2011/10/11 | Labeling Revision |
020634 | 061 | AP | 2012/04/27 | Efficacy Supplement with Clinical Data to Support |
020634 | 059 | AP | 2011/06/09 | Labeling Revision |
020634 | 058 | AP | 2011/02/25 | Labeling Revision |
020634 | 054 | AP | 2009/03/12 | Labeling Revision |
020634 | 053 | AP | 2009/04/27 | Labeling Revision |
020634 | 052 | AP | 2008/10/03 | Labeling Revision |
020634 | 051 | AP | 2008/04/16 | Labeling Revision |
020634 | 050 | AP | 2007/12/13 | Labeling Revision |
020634 | 049 | AP | 2007/11/16 | Labeling Revision |
020634 | 048 | AP | 2007/11/15 | Labeling Revision |
020634 | 047 | AP | 2008/05/05 | Patient Population Altered |
020634 | 045 | AP | 2007/06/19 | Labeling Revision |
020634 | 044 | AP | 2007/05/10 | Labeling Revision |
020634 | 043 | AP | 2007/09/11 | Patient Population Altered |
020634 | 042 | AP | 2007/05/31 | Labeling Revision |
020634 | 041 | AP | 2007/09/14 | New Dosage Regimen |
020634 | 040 | AP | 2006/06/23 | Labeling Revision |
020634 | 039 | AP | 2006/01/20 | Labeling Revision |
020634 | 037 | AP | 2005/08/04 | New Dosage Regimen |
020634 | 036 | AP | 2004/11/04 | Labeling Revision |
020634 | 035 | AP | 2004/11/24 | New or Modified Indication |
020634 | 034 | AP | 2004/09/14 | Labeling Revision |
020634 | 033 | AP | 2004/09/14 | Labeling Revision |
020634 | 030 | AP | 2004/07/14 | New or Modified Indication |
020634 | 029 | AP | 2004/03/05 | Labeling Revision |
020634 | 028 | AP | 2003/10/23 | New Dosage Regimen |
020634 | 027 | AP | 2003/05/23 | New or Modified Indication |
020634 | 026 | AP | 2002/06/12 | Control Supplement |
020634 | 025 | AP | 2002/10/30 | New or Modified Indication |
020634 | 024 | AP | 2002/04/30 | Control Supplement |
020634 | 023 | AP | 2002/01/11 | Control Supplement |
020634 | 022 | AP | 2001/12/18 | Labeling Revision |
020634 | 021 | AP | 2001/12/18 | Labeling Revision |
020634 | 020 | AP | 2001/06/08 | Manufacturing Change or Addition |
020634 | 019 | AP | 2001/02/13 | Control Supplement |
020634 | 018 | AP | 2001/01/04 | Manufacturing Change or Addition |
020634 | 017 | AP | 2000/09/15 | Control Supplement |
020634 | 016 | AP | 2000/12/13 | Package Change |
020634 | 015 | AP | 2001/12/18 | Labeling Revision |
020634 | 014 | AP | 2000/08/28 | Manufacturing Change or Addition |
020634 | 013 | AP | 2000/09/08 | New or Modified Indication |
020634 | 012 | AP | 2000/09/08 | Control Supplement |
020634 | 011 | AP | 2000/02/11 | Control Supplement |
020634 | 010 | AP | 1999/09/29 | Control Supplement |
020634 | 009 | AP | 2000/02/02 | Labeling Revision |
020634 | 008 | AP | 2000/02/02 | New or Modified Indication |
020634 | 007 | AP | 1999/07/29 | Labeling Revision |
020634 | 006 | AP | 1999/07/29 | Labeling Revision |
020634 | 005 | AP | 1999/07/29 | Labeling Revision |
020634 | 004 | AP | 1998/12/17 | New or Modified Indication |
020634 | 003 | AP | 1998/03/24 | Manufacturing Change or Addition |
020634 | 002 | AP | 1998/05/11 | Manufacturing Change or Addition |
020634 | 001 | AP | 1998/01/30 | Control Supplement |
020634 | 000 | AP | 1996/12/20 | Approval |