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 |
|---|
| 2024/07/05 |
ORIG-1（原始申请） |
Approval |
|
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:ZINC SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 10MG BASE/10ML (EQ 1MG BASE/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 |
|---|
| 209377 |
003 |
NDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2020/04/15
|
AM REGENT |
| 216145 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2022/12/27
|
FRESENIUS KABI USA |
| 217074 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2023/08/22
|
ZYDUS PHARMS |
| 216249 |
003 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2023/09/01
|
GLAND PHARMA LTD |
| 214597 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/07/05
|
NIVAGEN PHARMS INC |
| 218059 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/10/28
|
APOTEX |
活性成分:ZINC SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 25MG BASE/5ML (EQ 5MG BASE/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 |
|---|
| 209377 |
002 |
NDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2019/07/18
|
AM REGENT |
| 216249 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2022/05/03
|
GLAND PHARMA LTD |
| 216145 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2022/12/27
|
FRESENIUS KABI USA |
| 217074 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2023/08/22
|
ZYDUS PHARMS |
| 218059 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/06/10
|
APOTEX |
| 214597 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/07/05
|
NIVAGEN PHARMS INC |
| 216135 |
001 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/07/17
|
SOMERSET THERAPS LLC |
活性成分:ZINC SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 30MG BASE/10ML (EQ 3MG BASE/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 |
|---|
| 209377 |
001 |
NDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2019/07/18
|
AM REGENT |
| 216249 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
No |
No |
AP |
2022/05/03
|
GLAND PHARMA LTD |
| 216145 |
003 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
No |
No |
AP |
2022/12/27
|
FRESENIUS KABI USA |
| 217074 |
003 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
No |
No |
AP |
2023/08/22
|
ZYDUS PHARMS |
| 214597 |
003 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/07/05
|
NIVAGEN PHARMS INC |
| 216135 |
002 |
ANDA |
ZINC SULFATE |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/07/17
|
SOMERSET THERAPS LLC |