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 |
020564 | 036 | AP | 2016/07/20 | Efficacy Supplement with Clinical Data to Support |
020564 | 035 | AP | 2015/09/30 | Labeling Revision |
020564 | 034 | AP | 2015/02/19 | Labeling Revision |
020564 | 033 | AP | 2015/03/23 | Efficacy Supplement with Clinical Data to Support |
020564 | 032 | AP | 2012/12/18 | Manufacturing Change or Addition |
020564 | 031 | AP | 2011/11/18 | Labeling Revision |
020564 | 028 | AP | 2008/02/01 | Patient Population Altered |
020564 | 026 | AP | 2006/10/25 | Labeling Revision |
020564 | 024 | AP | 2006/06/13 | Labeling Revision |
020564 | 021 | AP | 2004/09/29 | Labeling Revision |
020564 | 020 | AP | 2004/11/22 | Approval |
020564 | 019 | AP | 2003/11/13 | Labeling Revision |
020564 | 017 | AP | 2002/09/13 | Manufacturing Change or Addition |
020564 | 016 | AP | 2002/03/01 | Labeling Revision |
020564 | 015 | AP | 2002/06/24 | New Dosage Regimen |
020564 | 014 | AP | 2002/10/08 | Labeling Revision |
020564 | 013 | AP | 2001/06/19 | Labeling Revision |
020564 | 012 | AP | 2001/03/06 | Labeling Revision |
020564 | 011 | AP | 2001/01/05 | Labeling Revision |
020564 | 010 | AP | 1999/03/08 | Labeling Revision |
020564 | 009 | AP | 1999/03/08 | Labeling Revision |
020564 | 008 | AP | 1998/11/05 | Control Supplement |
020564 | 007 | AP | 1999/03/23 | Efficacy Supplement with Clinical Data to Support |
020564 | 006 | AP | 1997/12/15 | Labeling Revision |
020564 | 005 | AP | 1998/02/03 | Manufacturing Change or Addition |
020564 | 004 | AP | 1997/12/15 | Labeling Revision |
020564 | 003 | AP | 1997/10/31 | Manufacturing Change or Addition |
020564 | 002 | AP | 1997/04/11 | New or Modified Indication |
020564 | 001 | AP | 1996/07/31 | Labeling Revision |
020564 | 000 | AP | 1995/11/17 | Approval |