批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2000/07/07 |
SUPPL-357（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/29 |
SUPPL-356（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/18 |
SUPPL-355（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/10/24 |
SUPPL-354（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/08 |
SUPPL-352（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/10 |
SUPPL-353（补充） |
Approval |
Labeling |
|
|
|
| 1995/09/19 |
SUPPL-349（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/03/01 |
SUPPL-350（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/09/06 |
SUPPL-348（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/06/17 |
SUPPL-347（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/06/23 |
SUPPL-346（补充） |
Approval |
Labeling |
|
|
|
| 1992/03/30 |
SUPPL-345（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/12 |
SUPPL-344（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/12 |
SUPPL-343（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/12 |
SUPPL-342（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/03/31 |
SUPPL-340（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/11/04 |
SUPPL-339（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/09/10 |
SUPPL-337（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/08/07 |
SUPPL-338（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/05/09 |
SUPPL-336（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/03/12 |
SUPPL-333（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/03/04 |
SUPPL-331（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/05 |
SUPPL-330（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/05 |
SUPPL-327（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/12/21 |
SUPPL-328（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/07/09 |
SUPPL-326（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/02/03 |
SUPPL-324（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/02/03 |
SUPPL-313（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/02/03 |
SUPPL-312（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/02/03 |
SUPPL-311（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/09/19 |
SUPPL-323（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/03/17 |
SUPPL-321（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/03/17 |
SUPPL-320（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/12/16 |
SUPPL-319（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/12/16 |
SUPPL-317（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/06/25 |
SUPPL-314（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/06/25 |
SUPPL-306（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/04/13 |
SUPPL-303（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1974/06/27 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |