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 |
1983/02/17 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/24 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/24 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1982/02/22 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1979/04/27 |
SUPPL-34(补充) |
Approval |
Labeling |
|
|
|
1979/04/03 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1978/03/24 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/11/24 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/04/01 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/11/26 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1973/06/08 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1973/06/08 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1972/05/04 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1971/12/17 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1970/10/12 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1970/07/21 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1970/04/20 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1970/03/27 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1970/03/27 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1970/02/10 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1969/11/26 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1969/11/14 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1969/10/06 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1969/08/05 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1969/06/30 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1969/06/05 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1969/03/14 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1968/08/08 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1967/08/07 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1967/03/20 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1966/12/15 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1966/11/25 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1966/09/19 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1966/02/25 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1965/01/22 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1964/11/06 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
1964/10/08 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1964/09/04 |
ORIG-1(原始申请) |
Approval |
|
UNKNOWN
|
|
|
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 |