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 |
|---|
| 1963/09/14 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
>>>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 |
|---|
| 2009/03/13 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 2009/03/13 |
SUPPL-46（补充） |
Approval |
Efficacy-New Route Of Administration |
|
|
|
| 2009/03/13 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 2001/09/24 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1997/04/21 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1997/03/19 |
SUPPL-52（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/07/13 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC)-Packaging |
PRIORITY
|
|
|
| 1991/04/05 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1987/01/16 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1986/06/18 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1985/01/31 |
SUPPL-35（补充） |
Approval |
Efficacy |
|
|
|
| 1983/03/02 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1981/11/20 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/02/08 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/01/10 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1979/06/18 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1979/04/23 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/09/19 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/09/01 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1978/08/14 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/12/08 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1977/10/06 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Packaging |
PRIORITY
|
|
|
| 1977/09/15 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1975/09/02 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1975/04/18 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1975/04/10 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1974/08/19 |
SUPPL-18（补充） |
Approval |
|
PRIORITY
|
|
|
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 |
