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 |
1997/04/15 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/02/22 |
SUPPL-58(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1993/11/10 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1993/06/08 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/08/27 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/07/16 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/01/07 |
SUPPL-53(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1991/11/13 |
SUPPL-50(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1991/03/07 |
SUPPL-46(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1990/05/30 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/11/13 |
SUPPL-49(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1989/06/26 |
SUPPL-45(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1989/06/26 |
SUPPL-44(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1988/06/15 |
SUPPL-42(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1988/05/20 |
SUPPL-41(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1988/03/31 |
SUPPL-40(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1986/04/29 |
SUPPL-33(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1986/04/23 |
SUPPL-38(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1986/01/13 |
SUPPL-37(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/05/15 |
SUPPL-36(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/04/18 |
SUPPL-35(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/02/07 |
SUPPL-34(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/12/05 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/07/19 |
SUPPL-31(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/07/19 |
SUPPL-27(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/06/14 |
SUPPL-32(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/03/05 |
SUPPL-29(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1983/03/11 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/02/28 |
SUPPL-25(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1983/01/31 |
SUPPL-24(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1982/12/30 |
SUPPL-18(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1982/12/30 |
SUPPL-11(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1982/08/25 |
SUPPL-22(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1982/01/22 |
SUPPL-19(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/11/02 |
SUPPL-17(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/07/13 |
SUPPL-16(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/06/12 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/01/22 |
SUPPL-13(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/01/22 |
SUPPL-12(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/07/08 |
SUPPL-10(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/01/08 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/16 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
PRIORITY
|
|
|
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 |