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 |
|---|
| 2021/03/18 |
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:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:14.9MG/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 |
|---|
| 019904 |
001 |
NDA |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
14.9MG/ML |
Prescription |
Yes |
Yes |
AP |
1989/12/26
|
BAXTER HLTHCARE |
| 020161 |
005 |
NDA |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
14.9MG/ML |
Prescription |
Yes |
Yes |
AP |
1992/11/30
|
ICU MEDICAL INC |
| 211087 |
001 |
ANDA |
POTASSIUM CHLORIDE 10MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
14.9MG/ML |
Prescription |
No |
No |
AP |
2020/09/09
|
FRESENIUS KABI USA |
| 214727 |
001 |
ANDA |
POTASSIUM CHLORIDE 10MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
14.9MG/ML |
Prescription |
No |
No |
AP |
2021/03/18
|
NEXUS |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:745MG/100ML 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 |
|---|
| 020161 |
001 |
NDA |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
745MG/100ML |
Prescription |
Yes |
Yes |
AP |
1992/11/30
|
ICU MEDICAL INC |
| 214727 |
002 |
ANDA |
POTASSIUM CHLORIDE 10MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
745MG/100ML |
Prescription |
No |
No |
AP |
2021/03/18
|
NEXUS |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:29.8MG/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 |
|---|
| 019904 |
002 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
29.8MG/ML |
Prescription |
Yes |
Yes |
AP |
1989/12/26
|
BAXTER HLTHCARE |
| 020161 |
006 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
29.8MG/ML |
Prescription |
Yes |
Yes |
AP |
1998/08/11
|
ICU MEDICAL INC |
| 211087 |
003 |
ANDA |
POTASSIUM CHLORIDE 20MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
29.8MG/ML |
Prescription |
No |
No |
AP |
2020/09/09
|
FRESENIUS KABI USA |
| 214727 |
003 |
ANDA |
POTASSIUM CHLORIDE 20MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
29.8MG/ML |
Prescription |
No |
No |
AP |
2021/03/18
|
NEXUS |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1.49GM/100ML 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 |
|---|
| 019904 |
006 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
1.49GM/100ML |
Prescription |
Yes |
Yes |
AP |
1990/12/17
|
BAXTER HLTHCARE |
| 020161 |
002 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
1.49GM/100ML |
Prescription |
Yes |
Yes |
AP |
1992/11/30
|
ICU MEDICAL INC |
| 214727 |
004 |
ANDA |
POTASSIUM CHLORIDE 20MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
1.49GM/100ML |
Prescription |
No |
No |
AP |
2021/03/18
|
NEXUS |
| 211087 |
005 |
ANDA |
POTASSIUM CHLORIDE 20MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
1.49GM/100ML |
Prescription |
No |
No |
AP |
2021/05/07
|
FRESENIUS KABI USA |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2.98GM/100ML 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 |
|---|
| 019904 |
004 |
NDA |
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2.98GM/100ML |
Prescription |
Yes |
Yes |
AP |
1989/12/26
|
BAXTER HLTHCARE |
| 020161 |
004 |
NDA |
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2.98GM/100ML |
Prescription |
Yes |
Yes |
AP |
1998/08/11
|
ICU MEDICAL INC |
| 211087 |
004 |
ANDA |
POTASSIUM CHLORIDE 40MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2.98GM/100ML |
Prescription |
No |
No |
AP |
2020/09/09
|
FRESENIUS KABI USA |
| 214727 |
005 |
ANDA |
POTASSIUM CHLORIDE 40MEQ |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2.98GM/100ML |
Prescription |
No |
No |
AP |
2021/03/18
|
NEXUS |
