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 |
020363 | 047 | AP | 2016/09/16 | Labeling Revision |
020363 | 046 | AP | 2015/09/10 | Manufacturing Change or Addition |
020363 | 045 | AP | 2015/10/19 | Manufacturing Change or Addition |
020363 | 044 | AP | 2015/05/14 | Manufacturing Change or Addition |
020363 | 042 | AP | 2013/04/24 | Labeling Revision |
020363 | 041 | AP | 2014/06/25 | Manufacturing Change or Addition |
020363 | 040 | AP | 2012/02/09 | Labeling Revision |
020363 | 038 | AP | 2012/02/09 | Efficacy Supplement with Clinical Data to Support |
020363 | 037 | AP | 2011/01/31 | Efficacy Supplement with Clinical Data to Support |
020363 | 036 | AP | 2009/12/24 | Efficacy Supplement with Clinical Data to Support |
020363 | 034 | AP | 2008/12/22 | Labeling Revision |
020363 | 028 | AP | 2006/07/28 | New or Modified Indication |
020363 | 027 | AP | 2006/07/28 | New Dosage Regimen |
020363 | 026 | AP | 2006/02/22 | Labeling Revision |
020363 | 020 | AP | 2002/08/06 | Manufacturing Change or Addition |
020363 | 019 | AP | 2001/03/29 | Labeling Revision |
020363 | 017 | AP | 1999/02/02 | Control Supplement |
020363 | 016 | AP | 1998/06/12 | Labeling Revision |
020363 | 015 | AP | 1998/03/26 | Control Supplement |
020363 | 014 | AP | 1998/06/12 | New or Modified Indication |
020363 | 013 | AP | 1997/07/15 | Labeling Revision |
020363 | 012 | AP | 1997/09/17 | New or Modified Indication |
020363 | 011 | AP | 1997/01/31 | Manufacturing Change or Addition |
020363 | 010 | AP | 1998/06/12 | Labeling Revision |
020363 | 009 | AP | 1997/01/13 | Labeling Revision |
020363 | 008 | AP | 1996/04/26 | Labeling Revision |
020363 | 007 | AP | 1996/07/29 | Labeling Revision |
020363 | 006 | AP | 1995/09/08 | Manufacturing Change or Addition |
020363 | 005 | AP | 1996/07/29 | Labeling Revision |
020363 | 004 | AP | 1995/12/11 | New or Modified Indication |
020363 | 001 | AP | 1994/12/27 | Manufacturing Change or Addition |
020363 | 000 | AP | 1994/06/29 | Approval |