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 |
2024/02/05 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2024/01/08 |
SUPPL-21(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/11/02 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/08/18 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/07/13 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2021/12/03 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2021/05/26 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/05/21 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/05/21 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/12/29 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/11/29 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/04/08 |
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: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 |
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 |