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 |
|---|
| 2018/07/11 |
SUPPL-64（补充） |
Approval |
|
STANDARD
|
|
|
| 2016/03/18 |
SUPPL-62（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/12/22 |
SUPPL-60（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/09/11 |
SUPPL-59（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/08/14 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/02/01 |
SUPPL-51（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/11/29 |
SUPPL-49（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/11/24 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/04/29 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/09/30 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/02/18 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/04/29 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/03/26 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/02/15 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/01/10 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/25 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/05/28 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/02/27 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/06/13 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/18 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/15 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/01/24 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/09/22 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/16 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/28 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/07/11 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1982/06/03 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/16 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/16 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/12/21 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/20 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/08/26 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1981/06/29 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/04/16 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/21 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/07 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/06 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/07/31 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/28 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/18 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/05/30 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/10 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/02 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/02/01 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
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 |
