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 |
2002/08/13 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/07/31 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/11/14 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
1995/08/11 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/03/27 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/08 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/05/13 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/03/31 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1992/03/31 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/03/31 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/10/28 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1991/02/13 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1991/02/13 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1991/02/13 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1991/02/13 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/02/13 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/04 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/04 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/12/14 |
SUPPL-36(补充) |
Approval |
Bioequivalence |
|
|
|
1989/03/09 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/14 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/14 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/14 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/12/23 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/12/23 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/05/29 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/05/29 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/02/21 |
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 |