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 |
|---|
| 1959/11/16 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
>>>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 |
|---|
| 2020/08/07 |
SUPPL-91（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
N/A
|
|
|
| 2013/05/07 |
SUPPL-90（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/03/31 |
SUPPL-89（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/02/27 |
SUPPL-87（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/01/30 |
SUPPL-86（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/06/15 |
SUPPL-83（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/08/20 |
SUPPL-85（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1999/05/28 |
SUPPL-84（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/12/20 |
SUPPL-81（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1987/04/29 |
SUPPL-77（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1987/04/29 |
SUPPL-63（补充） |
Approval |
Labeling |
|
|
|
| 1987/04/29 |
SUPPL-37（补充） |
Approval |
Efficacy-New Indication |
|
|
|
| 1986/07/11 |
SUPPL-75（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/11 |
SUPPL-74（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/11 |
SUPPL-73（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/11 |
SUPPL-72（补充） |
Approval |
Labeling |
|
|
|
| 1986/01/15 |
SUPPL-71（补充） |
Approval |
Labeling |
|
|
|
| 1985/12/05 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC)-Formulation |
PRIORITY
|
|
|
| 1985/12/04 |
SUPPL-70（补充） |
Approval |
Labeling |
|
|
|
| 1985/08/30 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1984/08/10 |
SUPPL-66（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1983/03/15 |
SUPPL-65（补充） |
Approval |
Labeling |
|
|
|
| 1982/07/28 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1982/03/04 |
SUPPL-64（补充） |
Approval |
Manufacturing (CMC)-Packaging |
PRIORITY
|
|
|
| 1981/02/27 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1980/09/27 |
SUPPL-61（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/25 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1979/08/03 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1979/05/24 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC)-Packaging |
PRIORITY
|
|
|
| 1979/04/30 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1978/11/27 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1978/08/28 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/08/16 |
SUPPL-54（补充） |
Approval |
|
PRIORITY
|
|
|
| 1978/08/08 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/07/19 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1978/05/23 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/11/16 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1977/11/16 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 1977/05/16 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1977/04/25 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/03/17 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1977/03/17 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1976/11/01 |
SUPPL-42（补充） |
Approval |
Labeling |
|
|
|
| 1976/10/18 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/10/18 |
SUPPL-35（补充） |
Approval |
Unspecified |
PRIORITY
|
|
|
| 1976/06/09 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC)-Control |
PRIORITY
|
|
|
| 1976/06/09 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC)-Control |
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 |
