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 |
020468 | 042 | AP | 2016/09/22 | Labeling Revision |
020468 | 041 | AP | 2016/03/22 | Manufacturing Change or Addition |
020468 | 040 | AP | 2015/06/18 | Labeling Revision |
020468 | 039 | AP | 2014/09/19 | Labeling Revision |
020468 | 038 | AP | 2014/06/12 | Manufacturing Change or Addition |
020468 | 037 | AP | 2013/12/07 | Manufacturing Change or Addition |
020468 | 036 | AP | 2013/05/24 | Manufacturing Change or Addition |
020468 | 035 | AP | 2013/10/11 | OTC Labeling |
020468 | 034 | AP | 2013/07/02 | Efficacy Supplement with Clinical Data to Support |
020468 | 033 | AP | 2013/07/02 | Efficacy Supplement with Clinical Data to Support |
020468 | 024 | AP | 2008/09/19 | Patient Population Altered |
020468 | 020 | AP | 2013/12/07 | Manufacturing Change or Addition |
020468 | 013 | AP | 2004/03/08 | Labeling Revision |
020468 | 012 | AP | 2003/12/23 | Labeling Revision |
020468 | 011 | AP | 2003/12/17 | Labeling Revision |
020468 | 008 | AP | 2002/05/06 | Package Change |
020468 | 007 | AP | 2002/03/12 | Manufacturing Change or Addition |
020468 | 005 | AP | 2000/08/17 | Control Supplement |
020468 | 003 | AP | 1996/10/15 | Control Supplement |
020468 | 002 | AP | 1997/09/26 | New or Modified Indication |
020468 | 001 | AP | 1996/08/23 | Control Supplement |
020468 | 000 | AP | 1996/05/20 | Approval |