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 |
2009/03/27 |
SUPPL-77(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2007/10/30 |
SUPPL-76(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2002/08/12 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/06/14 |
SUPPL-74(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1993/05/25 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/12/31 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/04/25 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/01/16 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/11/07 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/11/09 |
SUPPL-66(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/12/11 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/06/15 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/01/28 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/12/22 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/12/22 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/11/05 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/08/04 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/07/17 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/05/06 |
SUPPL-54(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/03/26 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/08/20 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/08/20 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/07/11 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/06/17 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/06/17 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/02/04 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/11/09 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/09/17 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/05/01 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/03/26 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/07/28 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/07/20 |
SUPPL-40(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/07/12 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/07/10 |
SUPPL-39(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/07/10 |
SUPPL-30(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/05/02 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/08/02 |
SUPPL-34(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1977/07/12 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/06/29 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/12/10 |
SUPPL-32(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/07/01 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/01/16 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1974/09/17 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1974/04/22 |
SUPPL-23(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1970/04/07 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |