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 |
2000/03/06 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/03/21 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/03/15 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/01 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1978/04/21 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/11/01 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1977/09/14 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1977/06/01 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1977/03/24 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1976/09/23 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1976/06/02 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/03/05 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/03/01 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1976/03/01 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1975/05/06 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1975/04/09 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1975/03/03 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/02/28 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1974/12/02 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1974/10/11 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1973/06/12 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1972/08/08 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1972/08/08 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1972/05/16 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1972/03/13 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1971/05/28 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1971/02/19 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1970/10/19 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1970/02/25 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1970/02/05 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1969/12/01 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1969/05/27 |
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 |