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 |
|---|
| 2020/03/13 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2019/12/27 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2017/01/26 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
;Orphan
|
|
|
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:THIOTEPA 剂型/给药途径:POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 规格:15MG/VIAL 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 |
|---|
| 208264 |
001 |
NDA |
TEPADINA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2017/01/26
|
ADIENNE SA |
| 213049 |
001 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
Prescription |
No |
No |
AP |
2020/03/04
|
MSN |
| 214222 |
001 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
Prescription |
No |
No |
AP |
2021/03/08
|
GLAND PHARMA LTD |
| 216037 |
001 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
Prescription |
No |
No |
AP |
2023/12/26
|
MEITHEAL |
| 217559 |
001 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
15MG/VIAL |
Prescription |
No |
No |
AP |
2024/08/20
|
BELOTECA |
活性成分:THIOTEPA 剂型/给药途径:POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 规格:100MG/VIAL 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 |
|---|
| 208264 |
002 |
NDA |
TEPADINA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2017/01/26
|
ADIENNE SA |
| 213049 |
002 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
Prescription |
No |
No |
AP |
2020/03/04
|
MSN |
| 214222 |
002 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
Prescription |
No |
No |
AP |
2022/01/03
|
GLAND PHARMA LTD |
| 211755 |
001 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/09/05
|
HIKMA |
| 216037 |
002 |
ANDA |
THIOTEPA |
THIOTEPA |
POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/12/26
|
MEITHEAL |
