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
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 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 |
|---|
| 1999/01/19 |
SUPPL-124（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/10/15 |
SUPPL-123（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/02/04 |
SUPPL-122（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/05/14 |
SUPPL-119（补充） |
Approval |
Labeling |
|
|
|
| 1991/05/14 |
SUPPL-118（补充） |
Approval |
Labeling |
|
|
|
| 1991/05/14 |
SUPPL-113（补充） |
Approval |
Labeling |
|
|
|
| 1991/02/19 |
SUPPL-120（补充） |
Approval |
Labeling |
|
|
|
| 1990/01/03 |
SUPPL-116（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/06/12 |
SUPPL-117（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/12/14 |
SUPPL-115（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/10/26 |
SUPPL-114（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/05/12 |
SUPPL-112（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/03/27 |
SUPPL-111（补充） |
Approval |
Labeling |
|
|
|
| 1981/03/23 |
SUPPL-109（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-108（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-107（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-106（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-105（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-104（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-102（补充） |
Approval |
Efficacy |
|
|
|
| 1981/03/23 |
SUPPL-99（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-101（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-100（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-98（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-97（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-96（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-95（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/01/23 |
SUPPL-92（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-91（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-89（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-84（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-82（补充） |
Approval |
Efficacy |
|
|
|
| 1980/01/23 |
SUPPL-80（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-79（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-78（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-76（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-74（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-73（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-72（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-71（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-70（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-69（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-68（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-67（补充） |
Approval |
Labeling |
|
|
|
| 1980/01/23 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-65（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/07 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1976/07/20 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/03 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/03 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/03 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/03/01 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/03/01 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/03/01 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/10/03 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1974/12/26 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |