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 |
019898 | 066 | AP | 2016/07/05 | Labeling Revision |
019898 | 065 | AP | 2013/05/29 | Manufacturing Change or Addition |
019898 | 064 | AP | 2012/10/31 | Labeling Revision |
019898 | 063 | AP | 2012/10/31 | Labeling Revision |
019898 | 062 | AP | 2012/02/28 | Labeling Revision |
019898 | 061 | AP | 2011/05/18 | Labeling Revision |
019898 | 060 | AP | 2007/02/28 | Efficacy Supplement with Clinical Data to Support |
019898 | 058 | AP | 2005/07/06 | Labeling Revision |
019898 | 054 | AP | 2003/09/05 | Labeling Revision |
019898 | 052 | AP | 2002/10/29 | Patient Population Altered |
019898 | 051 | AP | 2002/06/14 | Control Supplement |
019898 | 050 | AP | 2002/07/12 | Labeling Revision |
019898 | 049 | AP | 2002/01/14 | Manufacturing Change or Addition |
019898 | 046 | AP | 2001/12/18 | New Dosage Regimen |
019898 | 045 | AP | 2001/08/13 | Manufacturing Change or Addition |
019898 | 044 | AP | 2001/03/14 | Control Supplement |
019898 | 043 | AP | 2001/03/12 | Manufacturing Change or Addition |
019898 | 042 | AP | 2001/06/15 | Efficacy Supplement with Clinical Data to Support |
019898 | 041 | AP | 2000/08/24 | Formulation Revision |
019898 | 037 | AP | 2000/06/23 | Efficacy Supplement with Clinical Data to Support |
019898 | 036 | AP | 1999/09/13 | Labeling Revision |
019898 | 035 | AP | 1999/10/14 | Manufacturing Change or Addition |
019898 | 034 | AP | 1999/10/14 | New or Modified Indication |
019898 | 032 | AP | 2000/02/10 | New or Modified Indication |
019898 | 031 | AP | 2000/06/09 | New or Modified Indication |
019898 | 030 | AP | 2000/01/18 | New Dosage Regimen |
019898 | 029 | AP | 2000/01/18 | New Dosage Regimen |
019898 | 027 | AP | 2000/01/18 | New or Modified Indication |
019898 | 026 | AP | 2000/01/18 | New or Modified Indication |
019898 | 025 | AP | 1999/04/09 | Control Supplement |
019898 | 024 | AP | 1999/01/28 | Manufacturing Change or Addition |
019898 | 023 | AP | 1999/02/11 | Manufacturing Change or Addition |
019898 | 022 | AP | 1998/10/26 | Package Change |
019898 | 021 | AP | 1998/08/17 | Labeling Revision |
019898 | 020 | AP | 1998/03/11 | New or Modified Indication |
019898 | 019 | AP | 1998/05/20 | Labeling Revision |
019898 | 018 | AP | 1998/03/27 | New or Modified Indication |
019898 | 017 | AP | 1997/04/15 | Labeling Revision |
019898 | 016 | AP | 1996/04/04 | Control Supplement |
019898 | 015 | AP | 1996/07/02 | New or Modified Indication |
019898 | 014 | AP | 1996/02/28 | Control Supplement |
019898 | 013 | AP | 1996/03/22 | New or Modified Indication |
019898 | 012 | AP | 1996/04/30 | Control Supplement |
019898 | 011 | AP | 1994/09/28 | Labeling Revision |
019898 | 010 | AP | 1995/03/30 | Labeling Revision |
019898 | 009 | AP | 1994/03/02 | Labeling Revision |
019898 | 008 | AP | 1994/02/09 | Formulation Revision |
019898 | 007 | AP | 1994/02/08 | Labeling Revision |
019898 | 006 | AP | 1993/07/23 | Control Supplement |
019898 | 005 | AP | 1992/07/07 | Package Change |
019898 | 004 | AP | 1993/03/22 | Control Supplement |
019898 | 003 | AP | 1993/03/22 | Labeling Revision |
019898 | 001 | AP | 1992/03/18 | Manufacturing Change or Addition |
019898 | 000 | AP | 1991/10/31 | Approval |