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 |
|---|
| 1972/08/28 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
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 |
|---|
| 2010/01/21 |
SUPPL-48（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2006/09/20 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/10/08 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/09/22 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/12/09 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1996/07/01 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/07/05 |
SUPPL-41（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1990/03/21 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/02/25 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1986/04/16 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1986/04/16 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1986/04/16 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/17 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/17 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1985/03/24 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 1984/06/06 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 1984/05/16 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/02/22 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1981/10/28 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1981/09/24 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/07/24 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/07/10 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 1979/12/04 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1979/12/04 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1979/09/06 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1979/04/16 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1978/05/30 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1977/10/06 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1977/09/10 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1977/05/03 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1976/11/04 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1976/11/04 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1976/09/03 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/03/26 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1975/10/07 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/08/04 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/07/16 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/06/18 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1974/11/11 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1974/07/17 |
SUPPL-4（补充） |
Approval |
|
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 |
