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 |
2002/08/23 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/12 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/12/04 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/04/12 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/10/02 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/09/28 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/12/05 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/03 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/08/13 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/11/07 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/10/17 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/03/30 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/07/18 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/09/17 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/05/12 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/05/22 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/02 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/10/27 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/10/27 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/10/27 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/10/27 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/10/27 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1976/04/07 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/12/11 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/12/11 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1975/06/26 |
SUPPL-9(补充) |
Approval |
Supplement |
STANDARD
|
|
|
1975/05/27 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1974/11/25 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1974/11/25 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1969/11/28 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
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 |