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 |
1982/04/19 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/10/02 |
SUPPL-47(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/01/09 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/10/02 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/08/19 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/09/05 |
SUPPL-43(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/07/23 |
SUPPL-42(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/05/31 |
SUPPL-41(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/04/30 |
SUPPL-40(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/04/11 |
SUPPL-39(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/11/28 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/11/06 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/11/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/30 |
SUPPL-35(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1977/05/11 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/07/16 |
SUPPL-33(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/10/31 |
SUPPL-30(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/07/30 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/07/30 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/04/03 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1974/12/09 |
SUPPL-25(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1974/11/08 |
SUPPL-22(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1974/09/26 |
SUPPL-26(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1969/02/03 |
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 |