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 |
| 1963/07/03 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
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>>>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 |
| 1996/04/26 |
SUPPL-52(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
| 1996/04/26 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
| 1981/03/11 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
| 1981/01/16 |
SUPPL-49(补充) |
Approval |
Labeling |
|
|
|
| 1980/09/25 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
| 1980/08/26 |
SUPPL-47(补充) |
Approval |
Labeling |
|
|
|
| 1980/04/24 |
SUPPL-46(补充) |
Approval |
Labeling |
|
|
|
| 1980/02/28 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
| 1980/02/28 |
SUPPL-43(补充) |
Approval |
Labeling |
|
|
|
| 1979/08/08 |
SUPPL-42(补充) |
Approval |
Labeling |
|
|
|
| 1979/07/17 |
SUPPL-41(补充) |
Approval |
Labeling |
|
|
|
| 1979/05/18 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
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| 1978/07/21 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
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| 1978/06/30 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
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| 1978/05/05 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
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| 1975/05/22 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
| 1974/08/26 |
SUPPL-16(补充) |
Approval |
Labeling |
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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 |