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 |
|---|
| 2016/04/08 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
;Orphan
|
|
|
>>>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 |
|---|
| 2024/12/02 |
SUPPL-26（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
;Orphan
|
|
|
| 2024/02/05 |
SUPPL-23（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
;Orphan
|
|
|
| 2024/01/08 |
SUPPL-21（补充） |
Approval |
Efficacy-Accelerated Approval,Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2023/11/02 |
SUPPL-22（补充） |
Approval |
Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2022/08/18 |
SUPPL-18（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
;Orphan
|
|
|
| 2022/07/13 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Packaging |
N/A
|
|
|
| 2021/12/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Packaging |
N/A
|
|
|
| 2021/05/26 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/05/21 |
SUPPL-10（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
;Orphan
|
|
|
| 2018/05/21 |
SUPPL-6（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
;Orphan
|
|
|
| 2017/12/29 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
;Orphan
|
|
|
| 2016/11/29 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
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 |
与本品治疗等效的药品
>>>活性成分:METHYLENE BLUE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:50MG/10ML (5MG/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 |
|---|
| 204630 |
001 |
NDA |
PROVAYBLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2016/04/08
|
PROVEPHARM SAS |
| 215636 |
002 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2023/12/05
|
ZYDUS LIFESCIENCES |
| 217561 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/11/21
|
NEXUS |
| 216955 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/11/22
|
STERISCIENCE |
| 216959 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/12/17
|
HIKMA |
| 217380 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2025/01/23
|
MEITHEAL |
| 219363 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2025/07/30
|
XIROMED |
>>>活性成分:METHYLENE BLUE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:10MG/2ML (5MG/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 |
|---|
| 204630 |
002 |
NDA |
PROVAYBLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
10MG/2ML (5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2019/07/18
|
PROVEPHARM SAS |
| 215636 |
001 |
ANDA |
METHYLENE BLUE |
METHYLENE BLUE |
SOLUTION;INTRAVENOUS |
10MG/2ML (5MG/ML) |
Prescription |
No |
No |
AP |
2023/12/05
|
ZYDUS LIFESCIENCES |
