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 |
|---|
| 1962/05/17 |
ORIG-1（原始申请） |
Approval |
|
UNKNOWN
|
|
|
>>>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 |
|---|
| 2019/01/05 |
SUPPL-59（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2016/03/29 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2013/12/06 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2009/06/02 |
SUPPL-50（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/03/01 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/12/05 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 2001/09/27 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/23 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1997/01/08 |
SUPPL-43（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/08/02 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1991/07/01 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/03/17 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
|
|
|
| 1985/12/17 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/03/23 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1983/09/13 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1982/12/28 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1982/08/03 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/03/18 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1982/03/05 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1981/10/19 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1980/10/15 |
SUPPL-38（补充） |
Approval |
Labeling |
|
|
|
| 1979/10/17 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1978/07/19 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1976/11/18 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1972/10/16 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1968/11/20 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1967/11/24 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1967/07/17 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1967/07/14 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1967/04/18 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1967/03/08 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 1967/01/31 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1967/01/31 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 1966/12/30 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1966/12/21 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1966/10/31 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1966/05/20 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1966/04/22 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1966/01/07 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1965/12/14 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1965/11/15 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1965/07/27 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1965/05/26 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1965/04/16 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1964/08/20 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1964/05/14 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1964/04/16 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
|
|
|
| 1964/04/16 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
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 |
