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 |
|---|
| 2018/04/30 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/11/29 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2007/01/02 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2006/04/13 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/05/24 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/11/21 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/07/18 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/07/18 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/12/16 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/04/08 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/07/02 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/06/26 |
SUPPL-8（补充） |
Approval |
Efficacy |
|
|
|
| 1991/10/31 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/07/18 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/07/17 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/09/21 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/09/18 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/24 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/11/07 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/06/02 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1987/08/25 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/31 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/06/26 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/04/17 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/04/17 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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:8MEQ 治疗等效代码:AB2
| 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 |
|---|
| 019123 |
001 |
NDA |
KLOR-CON |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
Yes |
No |
AB2 |
1986/04/17
|
UPSHER SMITH LABS |
| 204662 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2014/08/21
|
MYLAN |
| 205993 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2015/11/05
|
PADAGIS US |
| 206759 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2016/08/09
|
NOVEL LABS INC |
| 209314 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2018/06/22
|
YICHANG HUMANWELL |
| 210733 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2018/08/31
|
STRIDES PHARMA |
| 210921 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2018/12/19
|
AUROBINDO PHARMA |
| 211797 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2020/03/04
|
GRANULES |
| 217412 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2023/12/19
|
RISING |
| 212987 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2024/09/06
|
MACLEODS PHARMS LTD |
| 218979 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MEQ |
Prescription |
No |
No |
AB2 |
2024/10/28
|
TWI PHARMS |
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:AB2
| 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 |
|---|
| 019123 |
002 |
NDA |
KLOR-CON |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
Yes |
Yes |
AB2 |
1986/04/17
|
UPSHER SMITH LABS |
| 204662 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2014/08/21
|
MYLAN |
| 205993 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2015/11/05
|
PADAGIS US |
| 206759 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2016/08/09
|
NOVEL LABS INC |
| 209314 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2018/06/22
|
YICHANG HUMANWELL |
| 210733 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2018/08/31
|
STRIDES PHARMA |
| 210921 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2018/12/19
|
AUROBINDO PHARMA |
| 211797 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2020/03/04
|
GRANULES |
| 217412 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2023/12/19
|
RISING |
| 212987 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2024/09/06
|
MACLEODS PHARMS LTD |
| 218979 |
002 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB2 |
2024/10/28
|
TWI PHARMS |
