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 |
|---|
| 2021/11/15 |
SUPPL-108（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/15 |
SUPPL-100（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/11 |
SUPPL-107（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/18 |
SUPPL-106（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/06/20 |
SUPPL-101（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/10/01 |
SUPPL-92（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/06/20 |
SUPPL-91（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/05/24 |
SUPPL-90（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/05/23 |
SUPPL-89（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/01/05 |
SUPPL-88（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/11/10 |
SUPPL-85（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/04/28 |
SUPPL-87（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/04/13 |
SUPPL-86（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/01/14 |
SUPPL-84（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/04/09 |
SUPPL-82（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/03/14 |
SUPPL-83（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/11/30 |
SUPPL-81（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/09/07 |
SUPPL-80（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/06/28 |
SUPPL-79（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/11/04 |
SUPPL-78（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/05/18 |
SUPPL-77（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/09/16 |
SUPPL-74（补充） |
Approval |
Labeling |
|
|
|
| 1990/07/26 |
SUPPL-75（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/01/18 |
SUPPL-73（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/10/23 |
SUPPL-72（补充） |
Approval |
Labeling |
|
|
|
| 1989/07/19 |
SUPPL-71（补充） |
Approval |
Labeling |
|
|
|
| 1988/10/28 |
SUPPL-70（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/09/09 |
SUPPL-69（补充） |
Approval |
Labeling |
|
|
|
| 1987/11/23 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/02/26 |
SUPPL-68（补充） |
Approval |
Labeling |
|
|
|
| 1985/10/21 |
SUPPL-65（补充） |
Approval |
Labeling |
|
|
|
| 1985/04/05 |
SUPPL-63（补充） |
Approval |
Labeling |
|
|
|
| 1984/06/21 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/01/30 |
SUPPL-61（补充） |
Approval |
Labeling |
|
|
|
| 1983/09/29 |
SUPPL-60（补充） |
Approval |
Labeling |
|
|
|
| 1983/06/15 |
SUPPL-59（补充） |
Approval |
Labeling |
|
|
|
| 1983/06/09 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/09/29 |
SUPPL-56（补充） |
Approval |
Labeling |
|
|
|
| 1980/11/20 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/21 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/03/24 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/11/08 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/19 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/15 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 1979/06/21 |
SUPPL-39（补充） |
Approval |
REMS |
STANDARD
|
|
|
| 1978/12/19 |
SUPPL-44（补充） |
Approval |
Labeling |
|
|
|
| 1978/09/25 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/05/25 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/04/17 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/03/29 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/18 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/18 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/18 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/07 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/05/21 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/05/21 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/05/21 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/05/21 |
SUPPL-6（补充） |
Approval |
REMS |
STANDARD
|
|
|
| 1975/03/06 |
SUPPL-5（补充） |
Approval |
REMS |
STANDARD
|
|
|
| 1973/01/02 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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 |
