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 |
2014/06/04 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/11/26 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/16 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/12/20 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/06/24 |
ORIG-1(原始申请) |
Approval |
Type 7 - Drug Already Marketed without Approved NDA |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:POWDER;INTRAVENOUS 规格:100MCG/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 |
202231 |
001 |
NDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
100MCG/VIAL |
Prescription |
Yes |
Yes |
AP |
2011/06/24
|
FRESENIUS KABI USA |
206163 |
001 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
100MCG/VIAL |
Prescription |
No |
No |
AP |
2016/06/29
|
PIRAMAL CRITICAL |
208749 |
001 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
100MCG/VIAL |
Prescription |
No |
No |
AP |
2018/12/21
|
MAIA PHARMS INC |
217066 |
001 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
100MCG/VIAL |
Prescription |
No |
No |
AP |
2023/03/24
|
ZYDUS PHARMS |
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:POWDER;INTRAVENOUS 规格:200MCG/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 |
202231 |
002 |
NDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
200MCG/VIAL |
Prescription |
Yes |
Yes |
AP |
2011/06/24
|
FRESENIUS KABI USA |
208749 |
002 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
200MCG/VIAL |
Prescription |
No |
No |
AP |
2018/12/21
|
MAIA PHARMS INC |
217066 |
002 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
200MCG/VIAL |
Prescription |
No |
No |
AP |
2023/03/24
|
ZYDUS PHARMS |
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:POWDER;INTRAVENOUS 规格:500MCG/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 |
202231 |
003 |
NDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
500MCG/VIAL |
Prescription |
Yes |
Yes |
AP |
2011/06/24
|
FRESENIUS KABI USA |
206163 |
002 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
500MCG/VIAL |
Prescription |
No |
No |
AP |
2016/06/29
|
PIRAMAL CRITICAL |
208749 |
003 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
500MCG/VIAL |
Prescription |
No |
No |
AP |
2018/12/21
|
MAIA PHARMS INC |
217066 |
003 |
ANDA |
LEVOTHYROXINE SODIUM |
LEVOTHYROXINE SODIUM |
POWDER;INTRAVENOUS |
500MCG/VIAL |
Prescription |
No |
No |
AP |
2023/03/24
|
ZYDUS PHARMS |