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 |
2020/08/20 |
SUPPL-71(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/06 |
SUPPL-70(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/12/01 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/12/01 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/01/12 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/07/27 |
SUPPL-66(补充) |
Approval |
Labeling |
|
|
|
1994/03/30 |
SUPPL-64(补充) |
Approval |
Labeling |
|
|
|
1994/01/24 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/08/11 |
SUPPL-63(补充) |
Approval |
Labeling |
|
|
|
1990/08/21 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/08/21 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/11/21 |
SUPPL-61(补充) |
Approval |
Labeling |
|
|
|
1989/11/09 |
SUPPL-62(补充) |
Approval |
Labeling |
|
|
|
1989/08/23 |
SUPPL-60(补充) |
Approval |
Labeling |
|
|
|
1988/05/27 |
SUPPL-59(补充) |
Approval |
Labeling |
|
|
|
1987/06/03 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/03 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/03 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/03 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/04/23 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/04/12 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/17 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/17 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/09 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/07/08 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/07/08 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/07/08 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/07/08 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/12/17 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |