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 |
2011/08/25 |
SUPPL-25(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
1998/10/09 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/03/07 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/02/24 |
SUPPL-22(补充) |
Approval |
Efficacy |
|
|
|
1986/12/09 |
SUPPL-21(补充) |
Approval |
Efficacy |
|
|
|
1986/12/09 |
SUPPL-20(补充) |
Approval |
Efficacy |
|
|
|
1984/03/15 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1983/03/10 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/03/08 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/02/22 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/10/18 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/09/14 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/02/08 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/12/31 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1981/04/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/04/25 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/12/26 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/04/19 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/04/12 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/08/11 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/08/11 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/07/14 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/12/16 |
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 |
与本品治疗等效的药品
活性成分:THALLOUS CHLORIDE TL-201 剂型/给药途径:INJECTABLE;INJECTION 规格:1mCi/ML 治疗等效代码:AP
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
017806 |
001 |
NDA |
THALLOUS CHLORIDE TL 201 |
THALLOUS CHLORIDE TL-201 |
INJECTABLE;INJECTION |
1mCi/ML |
Discontinued |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
LANTHEUS MEDCL |
018150 |
001 |
NDA |
THALLOUS CHLORIDE TL 201 |
THALLOUS CHLORIDE TL-201 |
INJECTABLE;INJECTION |
1mCi/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
CURIUM |