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 |
|---|
| 1975/08/22 |
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 |
|---|
| 2002/07/30 |
SUPPL-49（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/12/20 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2000/10/12 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2000/08/31 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/05/20 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/02/18 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1998/02/17 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1996/08/22 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/01/22 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/04/05 |
SUPPL-39（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/10/31 |
SUPPL-38（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/10/21 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1994/05/31 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/12/06 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1993/06/09 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1991/01/17 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/28 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/08/23 |
SUPPL-21（补充） |
Approval |
Efficacy-New Indication |
|
|
|
| 1988/04/18 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1987/12/04 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1986/09/15 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1986/03/18 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1985/08/23 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1985/07/29 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/05/20 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Formulation |
STANDARD
|
|
|
| 1985/05/20 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/07/18 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/07/18 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1983/07/11 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/02/11 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1982/01/20 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1981/10/22 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/10/28 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1979/10/26 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
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 |
