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 |
2004/05/27 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/08/01 |
SUPPL-61(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1999/02/24 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/10/05 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/08/10 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/04/06 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/09/02 |
SUPPL-58(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1994/08/23 |
SUPPL-55(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1992/09/15 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/09/15 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/04/16 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/12/16 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/09/02 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/16 |
SUPPL-42(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1986/04/21 |
SUPPL-40(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1986/04/21 |
SUPPL-37(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1985/01/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/03/08 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/10/28 |
SUPPL-34(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/10/28 |
SUPPL-33(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/05/20 |
SUPPL-32(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/04/16 |
SUPPL-31(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/01/18 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/09/26 |
SUPPL-30(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/07/17 |
SUPPL-29(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1979/03/26 |
SUPPL-28(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/10/13 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/05/26 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/05/03 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/05/03 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/07/23 |
SUPPL-20(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/01/06 |
SUPPL-14(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1957/11/12 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
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 |