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 |
|---|
| 2024/05/09 |
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:TABLET, EXTENDED RELEASE;ORAL 规格:10MEQ 治疗等效代码:AB1
| 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 |
|---|
| 074726 |
002 |
ANDA |
KLOR-CON M10 |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2000/08/09
|
UPSHER SMITH LABS |
| 075604 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2002/04/10
|
ACTAVIS LABS FL INC |
| 206347 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2016/01/21
|
NOVEL LABS INC |
| 203562 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2016/07/26
|
GLENMARK PHARMS LTD |
| 209922 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2019/04/30
|
PRINSTON INC |
| 076368 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2019/06/05
|
ADARE PHARMS INC |
| 212861 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2020/05/08
|
AMNEAL |
| 210395 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2020/09/17
|
ZYDUS PHARMS |
| 214452 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2020/10/21
|
GRANULES |
| 214422 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2020/12/29
|
ASCENT PHARMS INC |
| 214395 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2021/01/28
|
GUANGZHOU NOVAKEN |
| 216321 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2023/06/16
|
RUBICON |
| 216269 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB1 |
2024/05/09
|
MACLEODS PHARMS LTD |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:15MEQ 治疗等效代码:AB1
| 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 |
|---|
| 074726 |
003 |
ANDA |
KLOR-CON M15 |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB1 |
2003/06/06
|
UPSHER SMITH LABS |
| 209922 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB1 |
2019/04/30
|
PRINSTON INC |
| 214422 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB1 |
2020/12/29
|
ASCENT PHARMS INC |
| 216321 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB1 |
2023/06/16
|
RUBICON |
| 216269 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB1 |
2024/05/09
|
MACLEODS PHARMS LTD |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:20MEQ 治疗等效代码:AB1
| 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 |
|---|
| 074726 |
001 |
ANDA |
KLOR-CON M20 |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
Yes |
AB1 |
1998/11/20
|
UPSHER SMITH LABS |
| 075604 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2002/04/10
|
ACTAVIS LABS FL INC |
| 076368 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2004/08/18
|
ADARE PHARMS INC |
| 206347 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2016/01/21
|
NOVEL LABS INC |
| 203562 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2016/07/26
|
GLENMARK PHARMS LTD |
| 209922 |
003 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2019/04/30
|
PRINSTON INC |
| 212861 |
003 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2020/05/08
|
AMNEAL |
| 210395 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2020/09/17
|
ZYDUS PHARMS |
| 214452 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2020/10/21
|
GRANULES |
| 214422 |
003 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2020/12/29
|
ASCENT PHARMS INC |
| 214395 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2021/01/28
|
GUANGZHOU NOVAKEN |
| 216321 |
003 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2023/06/16
|
RUBICON |
| 216269 |
003 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ |
Prescription |
No |
No |
AB1 |
2024/05/09
|
MACLEODS PHARMS LTD |