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 |
|---|
| 2023/03/07 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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:POTASSIUM CHLORIDE; 剂型/给药途径:SOLUTION;ORAL; 规格:20MEQ/15ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 216536 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
--
|
AUROBINDO PHARMA |
| 206814 |
001 |
NDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
Yes |
No |
AA |
2014/12/22
|
GENUS LIFESCIENCES |
| 210041 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2018/07/19
|
AMNEAL |
| 211067 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2018/08/08
|
APOTEX |
| 209786 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2018/08/29
|
NOVEL LABS INC |
| 210766 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2019/03/29
|
PHARM ASSOC |
| 213392 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2021/01/29
|
GRANULES |
| 211648 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2021/05/21
|
SCIEGEN PHARMS INC |
| 214656 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2022/01/13
|
RUBICON RESEARCH |
| 213062 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2022/06/06
|
WES PHARMA INC |
| 214892 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2022/12/30
|
ANDA REPOSITORY |
| 216156 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2023/03/07
|
AJENAT PHARMS |
| 211665 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2024/01/16
|
STRIDES PHARMA |
| 211992 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2025/04/09
|
ASCENT PHARMS INC |
| 218960 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2025/07/22
|
TARO |
| 218733 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
20MEQ/15ML |
Prescription |
No |
No |
AA |
2025/09/10
|
MACLEODS PHARMS LTD |
>>>活性成分:POTASSIUM CHLORIDE; 剂型/给药途径:SOLUTION;ORAL; 规格:40MEQ/15ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 216536 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
--
|
AUROBINDO PHARMA |
| 206814 |
002 |
NDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
Yes |
Yes |
AA |
2014/12/22
|
GENUS LIFESCIENCES |
| 210041 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2018/07/19
|
AMNEAL |
| 211067 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2018/08/08
|
APOTEX |
| 209786 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2018/08/29
|
NOVEL LABS INC |
| 210766 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2019/03/29
|
PHARM ASSOC |
| 213392 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2021/01/29
|
GRANULES |
| 211648 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2021/05/21
|
SCIEGEN PHARMS INC |
| 214656 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2022/01/13
|
RUBICON RESEARCH |
| 213062 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2022/06/06
|
WES PHARMA INC |
| 211665 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Discontinued |
No |
No |
AA |
2022/11/17
|
STRIDES PHARMA |
| 214892 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2022/12/30
|
ANDA REPOSITORY |
| 216156 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2023/03/07
|
AJENAT PHARMS |
| 211992 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2025/04/09
|
ASCENT PHARMS INC |
| 218733 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
SOLUTION;ORAL |
40MEQ/15ML |
Prescription |
No |
No |
AA |
2025/09/10
|
MACLEODS PHARMS LTD |