| 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 |
| 050580 | 043 | AP | 2014/09/30 | Manufacturing Change or Addition |
| 050580 | 042 | AP | 2013/06/17 | Labeling Revision |
| 050580 | 040 | AP | 2008/01/22 | Labeling Revision |
| 050580 | 037 | AP | 2004/12/16 | Labeling Revision |
| 050580 | 036 | AP | 2002/11/27 | Manufacturing Change or Addition |
| 050580 | 035 | AP | 2002/09/13 | Control Supplement |
| 050580 | 034 | AP | 2002/06/24 | Manufacturing Change or Addition |
| 050580 | 033 | AP | 2002/03/25 | Labeling Revision |
| 050580 | 032 | AP | 1999/12/29 | Manufacturing Change or Addition |
| 050580 | 031 | AP | 1999/02/16 | Labeling Revision |
| 050580 | 030 | AP | 1997/11/07 | Manufacturing Change or Addition |
| 050580 | 029 | AP | 1997/06/12 | Manufacturing Change or Addition |
| 050580 | 028 | AP | 1999/02/16 | Labeling Revision |
| 050580 | 027 | AP | 1998/07/28 | Control Supplement |
| 050580 | 026 | AP | 1996/04/03 | Control Supplement |
| 050580 | 025 | AP | 1994/05/23 | Control Supplement |
| 050580 | 024 | AP | 1993/02/18 | Control Supplement |
| 050580 | 023 | AP | 1994/05/23 | Control Supplement |
| 050580 | 022 | AP | 1996/08/20 | Labeling Revision |
| 050580 | 021 | AP | 1996/08/20 | Labeling Revision |
| 050580 | 020 | AP | 1991/09/30 | Labeling Revision |
| 050580 | 019 | AP | 1992/06/25 | Labeling Revision |
| 050580 | 018 | AP | 1989/04/10 | Chemistry Generic |
| 050580 | 017 | AP | 1990/09/18 | Manufacturing Change or Addition |
| 050580 | 008 | AP | 1996/11/01 | New or Modified Indication |
| 050580 | 000 | AP | 1986/12/31 | Approval |
