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 |
019835 | 036 | AP | 2016/04/04 | Manufacturing Change or Addition |
019835 | 035 | AP | 2015/01/20 | Manufacturing Change or Addition |
019835 | 034 | AP | 2014/09/26 | Manufacturing Change or Addition |
019835 | 032 | AP | 2012/09/10 | Labeling Revision |
019835 | 030 | AP | 2012/03/13 | Labeling Revision |
019835 | 029 | AP | 2012/01/26 | Labeling Revision |
019835 | 028 | AP | 2010/02/26 | Labeling Revision |
019835 | 026 | AP | 2010/02/26 | Labeling Revision |
019835 | 025 | AP | 2008/11/25 | Manufacturing Change or Addition |
019835 | 022 | AP | 2007/11/16 | OTC Labeling |
019835 | 020 | AP | 2006/04/04 | Formulation Revision |
019835 | 016 | AP | 2004/03/17 | Labeling Revision |
019835 | 015 | AP | 2002/10/21 | Patient Population Altered |
019835 | 013 | AP | 2000/09/19 | Control Supplement |
019835 | 011 | AP | 2000/02/01 | Manufacturing Change or Addition |
019835 | 010 | AP | 2000/02/25 | Labeling Revision |
019835 | 009 | AP | 2000/02/04 | Package Change |
019835 | 008 | AP | 1999/07/09 | Manufacturing Change or Addition |
019835 | 007 | AP | 1999/01/27 | Manufacturing Change or Addition |
019835 | 006 | AP | 1998/05/22 | Control Supplement |
019835 | 005 | AP | 1998/05/15 | New or Modified Indication |
019835 | 004 | AP | 1996/11/01 | Labeling Revision |
019835 | 003 | AP | 1996/11/14 | Control Supplement |
019835 | 002 | AP | 1996/09/23 | Labeling Revision |
019835 | 001 | AP | 1996/05/23 | Control Supplement |
019835 | 000 | AP | 1995/12/08 | Approval |