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 |
|---|
| 1975/06/24 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2020/09/28 |
SUPPL-19（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
UNKNOWN
|
|
|
| 2000/10/27 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1997/09/08 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/27 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/04/23 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1988/12/19 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1986/11/03 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/11/03 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/09/13 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/09/22 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:THIAMINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:100MG/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 |
|---|
| 080556 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 080571 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
DR REDDYS |
| 080575 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
WEST-WARD PHARMS INT |
| 091623 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2012/06/25
|
MYLAN INSTITUTIONAL |
| 206106 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2017/12/01
|
SAGENT PHARMS INC |
| 208703 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2022/04/20
|
EUGIA PHARMA |
| 215692 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2023/03/06
|
CAPLIN |
| 217181 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2024/10/29
|
ONESOURCE SPECIALTY |
| 218471 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2024/11/06
|
ASPIRO |
| 217800 |
001 |
ANDA |
THIAMINE HYDROCHLORIDE |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2025/02/24
|
GLAND |