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 |
050684 | 087 | AP | 2016/09/07 | Manufacturing Change or Addition |
050684 | 086 | AP | 2016/06/10 | Labeling Revision |
050684 | 085 | AP | 2016/05/16 | Manufacturing Change or Addition |
050684 | 084 | AP | 2016/06/10 | Labeling Revision |
050684 | 083 | AP | 2015/12/18 | Labeling Revision |
050684 | 082 | AP | 2014/08/05 | Manufacturing Change or Addition |
050684 | 081 | AP | 2014/02/25 | Manufacturing Change or Addition |
050684 | 080 | AP | 2013/09/06 | Labeling Revision |
050684 | 079 | AP | 2013/08/20 | Manufacturing Change or Addition |
050684 | 078 | AP | 2013/03/27 | Manufacturing Change or Addition |
050684 | 074 | AP | 2013/09/06 | Labeling Revision |
050684 | 071 | AP | 2011/09/28 | Labeling Revision |
050684 | 063 | AP | 2013/09/06 | Labeling Revision |
050684 | 061 | AP | 2012/05/11 | Labeling Revision |
050684 | 055 | AP | 2012/05/11 | Labeling Revision |
050684 | 052 | AP | 2008/04/17 | Labeling Revision |
050684 | 051 | AP | 2008/04/17 | Labeling Revision |
050684 | 046 | AP | 2006/07/26 | Efficacy Supplement with Clinical Data to Support |
050684 | 045 | AP | 2005/09/30 | Formulation Revision |
050684 | 044 | AP | 2005/06/27 | Labeling Revision |
050684 | 039 | AP | 2005/03/15 | Labeling Revision |
050684 | 038 | AP | 2004/01/30 | Labeling Revision |
050684 | 035 | AP | 2003/05/01 | Labeling Revision |
050684 | 033 | AP | 2003/04/28 | New Dosage Regimen |
050684 | 032 | AP | 2002/12/04 | Package Change |
050684 | 031 | AP | 2002/10/10 | Control Supplement |
050684 | 030 | AP | 2002/03/15 | Control Supplement |
050684 | 029 | AP | 2002/03/15 | Expiration Date Change |
050684 | 028 | AP | 2002/03/14 | Control Supplement |
050684 | 027 | AP | 2002/02/26 | Control Supplement |
050684 | 026 | AP | 2001/12/19 | Control Supplement |
050684 | 023 | AP | 2001/08/20 | Package Change |
050684 | 021 | AP | 2001/02/01 | Control Supplement |
050684 | 020 | AP | 2000/11/22 | Manufacturing Change or Addition |
050684 | 019 | AP | 2000/11/21 | Control Supplement |
050684 | 018 | AP | 2000/08/01 | Control Supplement |
050684 | 017 | AP | 2000/08/01 | Control Supplement |
050684 | 016 | AP | 2000/08/01 | Package Change |
050684 | 015 | AP | 2002/03/27 | Labeling Revision |
050684 | 013 | AP | 1998/07/13 | Manufacturing Change or Addition |
050684 | 012 | AP | 1999/03/11 | Manufacturing Change or Addition |
050684 | 011 | AP | 1997/07/31 | Control Supplement |
050684 | 010 | AP | 1997/06/16 | Package Change |
050684 | 009 | AP | 1996/11/18 | Package Change |
050684 | 008 | AP | 1996/12/13 | Control Supplement |
050684 | 007 | AP | 1995/07/10 | Control Supplement |
050684 | 005 | AP | 1994/10/12 | Control Supplement |
050684 | 004 | AP | 1994/07/13 | Labeling Revision |
050684 | 003 | AP | 1994/08/24 | Package Change |
050684 | 002 | AP | 1994/07/13 | Labeling Revision |
050684 | 001 | AP | 1996/05/08 | New or Modified Indication |
050684 | 000 | AP | 1993/10/22 | Approval |