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 |
020261 | 051 | AP | 2016/09/19 | Manufacturing Change or Addition |
020261 | 050 | AP | 2015/11/05 | Manufacturing Change or Addition |
020261 | 049 | AP | 2015/06/17 | Manufacturing Change or Addition |
020261 | 048 | AP | 2012/10/31 | Labeling Revision |
020261 | 047 | AP | 2013/06/25 | Manufacturing Change or Addition |
020261 | 046 | AP | 2012/02/28 | Labeling Revision |
020261 | 042 | AP | 2011/06/17 | Labeling Revision |
020261 | 039 | AP | 2007/06/12 | Labeling Revision |
020261 | 037 | AP | 2006/03/22 | Labeling Revision |
020261 | 036 | AP | 2006/04/10 | Patient Population Altered |
020261 | 035 | AP | 2006/04/10 | New Dosage Regimen |
020261 | 034 | AP | 2005/01/05 | Labeling Revision |
020261 | 033 | AP | 2003/05/27 | New or Modified Indication |
020261 | 032 | AP | 2002/09/06 | Labeling Revision |
020261 | 031 | AP | 2002/02/11 | Manufacturing Change or Addition |
020261 | 030 | AP | 2001/09/25 | Labeling Revision |
020261 | 029 | AP | 2001/05/23 | Manufacturing Change or Addition |
020261 | 028 | AP | 2000/10/06 | Labeling Revision |
020261 | 027 | AP | 2000/07/26 | Manufacturing Change or Addition |
020261 | 025 | AP | 2000/12/18 | New or Modified Indication |
020261 | 024 | AP | 2000/10/23 | Efficacy Supplement with Clinical Data to Support |
020261 | 023 | AP | 1999/10/14 | Manufacturing Change or Addition |
020261 | 022 | AP | 1999/03/08 | Efficacy Supplement with Clinical Data to Support |
020261 | 021 | AP | 1999/05/14 | Control Supplement |
020261 | 020 | AP | 1999/04/21 | Package Change |
020261 | 019 | AP | 1999/01/04 | Labeling Revision |
020261 | 018 | AP | 1999/03/08 | New or Modified Indication |
020261 | 017 | AP | 1998/08/05 | Manufacturing Change or Addition |
020261 | 016 | AP | 1998/04/23 | Control Supplement |
020261 | 015 | AP | 1997/11/20 | Package Change |
020261 | 014 | AP | 1997/04/21 | Package Change |
020261 | 013 | AP | 1997/06/16 | Control Supplement |
020261 | 012 | AP | 1997/10/01 | New or Modified Indication |
020261 | 011 | AP | 1998/10/08 | Control Supplement |
020261 | 010 | AP | 1996/04/30 | Manufacturing Change or Addition |
020261 | 009 | AP | 1996/02/08 | Control Supplement |
020261 | 008 | AP | 1995/12/22 | Manufacturing Change or Addition |
020261 | 007 | AP | 1995/10/17 | Control Supplement |
020261 | 006 | AP | 1996/03/20 | New Dosage Regimen |
020261 | 005 | AP | 1995/05/03 | Labeling Revision |
020261 | 004 | AP | 1994/11/10 | Control Supplement |
020261 | 003 | AP | 1994/11/28 | Package Change |
020261 | 002 | AP | 1994/03/21 | Labeling Revision |
020261 | 001 | AP | 1995/03/13 | Control Supplement |
020261 | 000 | AP | 1993/12/31 | Approval |