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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1980/05/22 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 1995/10/03 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1990/10/03 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC)-Formulation |
STANDARD
|
|
|
| 1989/09/19 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1988/08/26 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1988/06/15 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1988/06/07 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1987/10/01 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1987/05/15 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1987/03/11 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/02/13 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1985/10/24 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1985/10/24 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1985/07/30 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1985/06/14 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
STANDARD
|
|
|
| 1985/05/24 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1985/05/15 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1984/08/13 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1983/06/09 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/06/09 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/05/04 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1983/05/04 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/05/04 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/01/04 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/04 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1981/10/01 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1981/03/17 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/08/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1980/08/14 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Packaging |
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 |