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
>>>原始批准或临时批准<<<
审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
1979/06/11 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
>>>补充申请<<<
审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
2007/12/07 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/04/02 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/10/01 |
SUPPL-22(补充) |
Approval |
Efficacy-New Patient Population |
STANDARD
|
|
|
1997/03/19 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/01/02 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
1995/12/20 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/04/01 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1992/08/06 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1991/10/28 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1985/11/04 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1985/05/20 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
1984/10/04 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/08/04 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
1983/01/18 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1982/07/20 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
1982/06/09 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1981/10/02 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1981/09/30 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1981/08/28 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
1981/06/05 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC)-Expiration Date |
STANDARD
|
|
|
1981/05/29 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1981/03/06 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1980/09/18 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC)-Control |
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 |