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 |
020998 | 048 | AP | 2016/05/09 | Labeling Revision |
020998 | 047 | AP | 2016/05/09 | Labeling Revision |
020998 | 045 | AP | 2014/07/28 | Manufacturing Change or Addition |
020998 | 042 | AP | 2013/07/29 | Manufacturing Change or Addition |
020998 | 041 | AP | 2012/11/16 | Manufacturing Change or Addition |
020998 | 033 | AP | 2011/02/04 | Labeling Revision |
020998 | 027 | AP | 2008/12/31 | New Dosage Regimen |
020998 | 026 | AP | 2008/01/14 | Labeling Revision |
020998 | 023 | AP | 2007/11/02 | Labeling Revision |
020998 | 022 | AP | 2007/06/01 | Labeling Revision |
020998 | 021 | AP | 2006/12/15 | Patient Population Altered |
020998 | 019 | AP | 2005/07/29 | Labeling Revision |
020998 | 018 | AP | 2005/07/29 | New or Modified Indication |
020998 | 017 | AP | 2005/02/09 | Labeling Revision |
020998 | 016 | AP | 2004/01/09 | Labeling Revision |
020998 | 014 | AP | 2002/09/16 | Package Change |
020998 | 013 | AP | 2002/08/29 | Control Supplement |
020998 | 012 | AP | 2001/08/15 | Control Supplement |
020998 | 011 | AP | 2001/07/30 | Control Supplement |
020998 | 010 | AP | 2001/10/18 | New or Modified Indication |
020998 | 009 | AP | 2002/06/07 | Efficacy Supplement with Clinical Data to Support |
020998 | 008 | AP | 2000/12/01 | Labeling Revision |
020998 | 007 | AP | 1999/12/23 | Labeling Revision |
020998 | 006 | AP | 2000/03/21 | Manufacturing Change or Addition |
020998 | 004 | AP | 2000/02/17 | Manufacturing Change or Addition |
020998 | 001 | AP | 1999/08/13 | Package Change |
020998 | 000 | AP | 1998/12/31 | Approval |