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 |
2000/05/01 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/02/15 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/02/15 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/23 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/08/30 |
SUPPL-47(补充) |
Approval |
Labeling |
|
|
|
1999/03/03 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/09/30 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
1998/01/30 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/23 |
SUPPL-42(补充) |
Approval |
Labeling |
|
|
|
1997/04/07 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/04/01 |
SUPPL-41(补充) |
Approval |
Labeling |
|
|
|
1996/06/10 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1994/07/13 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1994/06/02 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1994/05/24 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1992/12/03 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/06/23 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/06/23 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/08/19 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/01/26 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/07/28 |
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 |