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 |
2003/07/29 |
SUPPL-93(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2001/03/27 |
SUPPL-92(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2001/01/22 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/04/05 |
SUPPL-90(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2000/04/05 |
SUPPL-88(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2000/04/05 |
SUPPL-86(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2000/04/05 |
SUPPL-84(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1998/12/24 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/12/30 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/07/13 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/06/01 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/06/01 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/06/24 |
SUPPL-81(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1991/06/24 |
SUPPL-79(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1991/06/24 |
SUPPL-76(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1989/07/28 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/12/12 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/04/08 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/02/26 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/10 |
SUPPL-73(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1986/04/02 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1985/09/20 |
SUPPL-72(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/09/13 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/08/15 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/05/21 |
SUPPL-65(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1984/03/07 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/05/26 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/05/03 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/03/15 |
SUPPL-68(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/09/04 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/06/25 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/03/23 |
SUPPL-61(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1981/03/09 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/03/02 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/03/02 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/03/02 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/09/03 |
SUPPL-60(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/06/23 |
SUPPL-59(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/03/04 |
SUPPL-54(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/01/29 |
SUPPL-53(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1980/01/29 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/11/06 |
SUPPL-52(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1978/01/25 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/03/01 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/10/28 |
SUPPL-39(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1976/09/17 |
SUPPL-42(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1976/08/02 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/08/02 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/09/18 |
SUPPL-38(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/09/18 |
SUPPL-37(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
1975/09/17 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/09/17 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1961/04/07 |
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 |