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 |
1999/02/03 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/02/03 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1998/02/25 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/08/27 |
SUPPL-34(补充) |
Approval |
Labeling |
|
|
|
1986/08/27 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/11/08 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1983/07/22 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/19 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/19 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/24 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/01/08 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1979/12/30 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/05/19 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/02/23 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1973/07/11 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1973/03/23 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1973/03/23 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1972/09/12 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1972/08/09 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1972/06/27 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1972/03/22 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1971/07/12 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1971/05/03 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1969/10/28 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1964/11/05 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1963/12/10 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1963/12/10 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1963/08/26 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1963/06/11 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1963/04/08 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1962/07/26 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1961/12/01 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1961/12/01 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1961/05/19 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1961/05/19 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1957/04/17 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1955/08/17 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1953/04/30 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1952/09/09 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1951/06/01 |
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 |