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 |
020596 | 035 | AP | 2016/07/20 | Efficacy Supplement with Clinical Data to Support |
020596 | 034 | AP | 2015/09/30 | Labeling Revision |
020596 | 033 | AP | 2015/02/19 | Labeling Revision |
020596 | 032 | AP | 2015/03/23 | Efficacy Supplement with Clinical Data to Support |
020596 | 030 | AP | 2011/11/18 | Labeling Revision |
020596 | 027 | AP | 2006/10/25 | Labeling Revision |
020596 | 025 | AP | 2006/06/13 | Labeling Revision |
020596 | 022 | AP | 2004/09/29 | Labeling Revision |
020596 | 021 | AP | 2004/11/22 | Approval |
020596 | 020 | AP | 2003/11/13 | Labeling Revision |
020596 | 019 | AP | 2002/12/24 | Manufacturing Change or Addition |
020596 | 018 | AP | 2002/09/13 | Manufacturing Change or Addition |
020596 | 017 | AP | 2002/03/01 | Labeling Revision |
020596 | 016 | AP | 2002/06/24 | New Dosage Regimen |
020596 | 015 | AP | 2002/10/08 | Labeling Revision |
020596 | 014 | AP | 2001/06/19 | Labeling Revision |
020596 | 013 | AP | 2001/03/06 | Labeling Revision |
020596 | 012 | AP | 2001/01/05 | Labeling Revision |
020596 | 011 | AP | 1999/10/08 | Manufacturing Change or Addition |
020596 | 010 | AP | 1999/10/18 | Formulation Revision |
020596 | 009 | AP | 1999/03/08 | Labeling Revision |
020596 | 008 | AP | 1999/03/08 | Labeling Revision |
020596 | 007 | AP | 1999/03/23 | Efficacy Supplement with Clinical Data to Support |
020596 | 006 | AP | 1997/12/15 | Labeling Revision |
020596 | 005 | AP | 1998/02/03 | Manufacturing Change or Addition |
020596 | 004 | AP | 1997/12/15 | Labeling Revision |
020596 | 003 | AP | 1997/11/13 | Manufacturing Change or Addition |
020596 | 002 | AP | 1997/04/11 | New or Modified Indication |
020596 | 001 | AP | 1996/07/31 | Labeling Revision |
020596 | 000 | AP | 1995/11/17 | Approval |