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 |
|---|
| 2021/02/16 |
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:CAPSULE, EXTENDED RELEASE;ORAL 规格:8MEQ 治疗等效代码:AB
| 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 |
|---|
| 077419 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2008/06/02
|
ACTAVIS LABS FL INC |
| 200185 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2011/05/18
|
PADAGIS US |
| 202886 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Discontinued |
No |
No |
AB |
2013/12/26
|
ENDO OPERATIONS |
| 203106 |
001 |
ANDA |
KLOR-CON |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2015/07/10
|
UPSHER SMITH LABS |
| 205549 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2015/12/08
|
STRIDES PHARMA |
| 203002 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2015/12/18
|
LUPIN LTD |
| 204828 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2016/08/16
|
NOVEL LABS INC |
| 208864 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2017/03/17
|
ADARE PHARMS INC |
| 208445 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2019/03/11
|
ZYDUS PHARMS |
| 209026 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2019/06/11
|
PRINSTON INC |
| 214686 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB |
2021/02/16
|
GRANULES |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:10MEQ 治疗等效代码:AB
| 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 |
|---|
| 077419 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
Yes |
AB |
2008/06/02
|
ACTAVIS LABS FL INC |
| 200185 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2011/05/18
|
PADAGIS US |
| 202128 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2013/02/22
|
AMNEAL PHARMS |
| 202886 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Discontinued |
No |
No |
AB |
2013/12/26
|
ENDO OPERATIONS |
| 203106 |
002 |
ANDA |
KLOR-CON |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2015/07/10
|
UPSHER SMITH LABS |
| 205549 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2015/12/08
|
STRIDES PHARMA |
| 203002 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2015/12/18
|
LUPIN LTD |
| 202868 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Discontinued |
No |
No |
AB |
2016/01/19
|
GLENMARK PHARMS LTD |
| 204828 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2016/08/16
|
NOVEL LABS INC |
| 208864 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2017/03/17
|
ADARE PHARMS INC |
| 208445 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2019/03/11
|
ZYDUS PHARMS |
| 209026 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2019/06/11
|
PRINSTON INC |
| 214686 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2021/02/16
|
GRANULES |