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 |
2010/01/21 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/09/20 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/08 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/09/22 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/12/09 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/01 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/07/05 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1990/03/21 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/02/25 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/04/16 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/04/16 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1986/04/16 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1985/04/17 |
SUPPL-33(补充) |
Approval |
Labeling |
|
|
|
1985/04/17 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1985/03/24 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1984/06/06 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1984/05/16 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/02/22 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1981/10/28 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/09/24 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/24 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/10 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1979/12/04 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/12/04 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/09/06 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/04/16 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/05/30 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/10/06 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1977/09/10 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/05/03 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1976/11/04 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/04 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/03 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/03/26 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1975/10/07 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/08/04 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/07/16 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/06/18 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1974/11/11 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1974/07/17 |
SUPPL-4(补充) |
Approval |
Supplement |
STANDARD
|
|
|
1972/08/28 |
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 |