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 |
018612 | 077 | AP | 2015/09/10 | Manufacturing Change or Addition |
018612 | 076 | AP | 2015/09/30 | Labeling Revision |
018612 | 075 | AP | 2015/01/05 | Manufacturing Change or Addition |
018612 | 074 | AP | 2014/10/30 | Labeling Revision |
018612 | 073 | AP | 2014/06/11 | Labeling Revision |
018612 | 072 | AP | 2014/06/11 | Labeling Revision |
018612 | 071 | AP | 2014/02/21 | Manufacturing Change or Addition |
018612 | 070 | AP | 2014/04/17 | Manufacturing Change or Addition |
018612 | 069 | AP | 2013/10/11 | Manufacturing Change or Addition |
018612 | 068 | AP | 2013/10/30 | Labeling Revision |
018612 | 067 | AP | 2012/08/01 | Manufacturing Change or Addition |
018612 | 065 | AP | 2012/07/16 | Labeling Revision |
018612 | 061 | AP | 2012/02/15 | Labeling Revision |
018612 | 060 | AP | 2012/02/01 | Labeling Revision |
018612 | 058 | AP | 2011/09/12 | Manufacturing Change or Addition |
018612 | 057 | AP | 2011/09/27 | Labeling Revision |
018612 | 056 | AP | 2011/05/17 | Labeling Revision |
018612 | 052 | AP | 2009/05/06 | Efficacy Supplement with Clinical Data to Support |
018612 | 050 | AP | 2008/06/13 | Formulation Revision |
018612 | 049 | AP | 2007/06/26 | Labeling Revision |
018612 | 043 | AP | 2006/05/04 | Package Change |
018612 | 042 | AP | 2005/12/02 | Formulation Revision |
018612 | 037 | AP | 2004/06/18 | Formulation Revision |
018612 | 035 | AP | 2004/06/23 | Labeling Revision |
018612 | 034 | AP | 2004/04/23 | Formulation Revision |
018612 | 032 | AP | 2002/11/15 | Control Supplement |
018612 | 031 | AP | 2002/08/09 | Labeling Revision |
018612 | 028 | AP | 2000/09/25 | Formulation Revision |
018612 | 026 | AP | 2001/08/24 | Labeling Revision |
018612 | 025 | AP | 1998/12/23 | Comparative Efficacy Claim |
018612 | 024 | AP | 1998/11/04 | Control Supplement |
018612 | 022 | AP | 1996/02/09 | OTC Labeling |
018612 | 019 | AP | 1991/08/22 | Control Supplement |
018612 | 016 | AP | 1991/08/22 | Control Supplement |
018612 | 012 | AP | 1988/09/30 | Control Supplement |
018612 | 010 | AP | 1989/09/28 | Manufacturing Change or Addition |
018612 | 009 | AP | 1989/04/17 | Manufacturing Change or Addition |
018612 | 008 | AP | 1985/07/23 | Labeling Revision |
018612 | 007 | AP | 1988/09/12 | Labeling Revision |
018612 | 006 | AP | 1986/02/26 | Control Supplement |
018612 | 005 | AP | 1985/07/23 | Package Change |
018612 | 004 | AP | 1986/02/26 | Manufacturing Change or Addition |
018612 | 003 | AP | 1988/09/12 | Labeling Revision |
018612 | 002 | AP | 1984/03/02 | Labeling Revision |
018612 | 001 | AP | 1984/02/21 | Labeling Revision |
018612 | 000 | AP | 1984/01/13 | Approval |