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 |
2008/04/28 |
SUPPL-95(补充) |
Approval |
Labeling |
|
|
|
2002/04/19 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/12/10 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/09 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/10/07 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/05 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/09/28 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/09/28 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/09/28 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/08/11 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/09/22 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/03/07 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/05 |
SUPPL-76(补充) |
Approval |
Labeling |
|
|
|
1989/11/13 |
SUPPL-75(补充) |
Approval |
Labeling |
|
|
|
1989/10/26 |
SUPPL-74(补充) |
Approval |
Labeling |
|
|
|
1989/03/21 |
SUPPL-72(补充) |
Approval |
Labeling |
|
|
|
1987/06/15 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/15 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/15 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/05 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/12 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/09/19 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/07/18 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/07/18 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/14 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/06/17 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/06/17 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/06/17 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/07/29 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/01 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/01/28 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/01/28 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/12/19 |
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 |