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 |
|---|
| 1968/11/06 |
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 |
|---|
| 1986/07/17 |
SUPPL-108（补充） |
Approval |
Labeling |
|
|
|
| 1985/10/25 |
SUPPL-107（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/16 |
SUPPL-106（补充） |
Approval |
Labeling |
|
|
|
| 1984/11/13 |
SUPPL-104（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/09/27 |
SUPPL-101（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1984/07/30 |
SUPPL-103（补充） |
Approval |
Labeling |
|
|
|
| 1984/05/07 |
SUPPL-100（补充） |
Approval |
Labeling |
|
|
|
| 1984/03/06 |
SUPPL-96（补充） |
Approval |
Labeling |
|
|
|
| 1983/07/26 |
SUPPL-99（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/07/26 |
SUPPL-95（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/07/19 |
SUPPL-98（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/07/19 |
SUPPL-97（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/06/13 |
SUPPL-94（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/07/29 |
SUPPL-90（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/01/11 |
SUPPL-86（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/10/14 |
SUPPL-46（补充） |
Approval |
Labeling |
|
|
|
| 1980/04/17 |
SUPPL-81（补充） |
Approval |
Manufacturing (CMC)-Formulation |
STANDARD
|
|
|
| 1979/07/18 |
SUPPL-80（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/07/18 |
SUPPL-77（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1978/11/06 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1978/11/06 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1978/05/26 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1977/11/22 |
SUPPL-58（补充） |
Approval |
Labeling |
|
|
|
| 1977/11/22 |
SUPPL-57（补充） |
Approval |
Labeling |
|
|
|
| 1977/07/01 |
SUPPL-48（补充） |
Approval |
Labeling |
|
|
|
| 1977/07/01 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 1977/06/14 |
SUPPL-55（补充） |
Approval |
Labeling |
|
|
|
| 1977/06/14 |
SUPPL-54（补充） |
Approval |
Labeling |
|
|
|
| 1977/06/14 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1977/06/14 |
SUPPL-52（补充） |
Approval |
Labeling |
|
|
|
| 1976/09/29 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-42（补充） |
Approval |
Labeling |
|
|
|
| 1975/05/16 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/16 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
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 |