| 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 |
| 019676 | 042 | AP | 2012/04/10 | Labeling Revision |
| 019676 | 030 | AP | 2007/02/15 | Labeling Revision |
| 019676 | 026 | AP | 2006/02/23 | Efficacy Supplement with Clinical Data to Support |
| 019676 | 021 | AP | 2005/06/28 | Labeling Revision |
| 019676 | 020 | AP | 2005/06/28 | New or Modified Indication |
| 019676 | 018 | AP | 2001/09/17 | Manufacturing Change or Addition |
| 019676 | 017 | AP | 2001/05/02 | Manufacturing Change or Addition |
| 019676 | 016 | AP | 2000/04/13 | New Dosage Regimen |
| 019676 | 015 | AP | 1999/11/24 | Labeling Revision |
| 019676 | 014 | AP | 1999/11/03 | Manufacturing Change or Addition |
| 019676 | 013 | AP | 1999/12/01 | Efficacy Supplement with Clinical Data to Support |
| 019676 | 012 | AP | 1998/09/25 | Control Supplement |
| 019676 | 011 | AP | 1998/09/25 | Control Supplement |
| 019676 | 010 | AP | 1997/09/12 | Control Supplement |
| 019676 | 009 | AP | 1997/12/15 | New or Modified Indication |
| 019676 | 008 | AP | 1996/08/07 | Control Supplement |
| 019676 | 007 | AP | 1995/08/21 | Labeling Revision |
| 019676 | 006 | AP | 1995/09/22 | Control Supplement |
| 019676 | 004 | AP | 1996/02/01 | Manufacturing Change or Addition |
| 019676 | 003 | AP | 1995/02/03 | Manufacturing Change or Addition |
| 019676 | 002 | AP | 1994/08/03 | Manufacturing Change or Addition |
| 019676 | 001 | AP | 1994/07/21 | Manufacturing Change or Addition |
| 019676 | 000 | AP | 1994/03/09 | Approval |
