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 |
|---|
| 2014/08/06 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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 CITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:5MEQ 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 |
|---|
| 019071 |
001 |
NDA |
UROCIT-K |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
Yes |
No |
AB |
1985/08/30
|
MISSION PHARMA |
| 077440 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2006/06/09
|
RISING |
| 203546 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2014/08/06
|
ZYDUS PHARMS |
| 206813 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2017/09/11
|
STRIDES PHARMA |
| 209758 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2018/03/05
|
TEVA PHARMS USA INC |
| 214420 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2021/02/05
|
ASCENT PHARMS INC |
| 214426 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Prescription |
No |
No |
AB |
2021/02/19
|
HIBROW HLTHCARE |
| 213986 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
5MEQ |
Discontinued |
No |
No |
AB |
2024/02/06
|
TORRENT |
活性成分:POTASSIUM CITRATE 剂型/给药途径:TABLET, 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 |
|---|
| 019071 |
002 |
NDA |
UROCIT-K |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
Yes |
No |
AB |
1992/08/31
|
MISSION PHARMA |
| 077440 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2006/06/09
|
RISING |
| 203546 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2014/08/06
|
ZYDUS PHARMS |
| 206813 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2017/09/11
|
STRIDES PHARMA |
| 209758 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2018/03/05
|
TEVA PHARMS USA INC |
| 212779 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2020/01/14
|
ANI PHARMS |
| 212799 |
001 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2020/06/29
|
BIONPHARMA |
| 214420 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2021/02/05
|
ASCENT PHARMS INC |
| 214426 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Prescription |
No |
No |
AB |
2021/02/19
|
HIBROW HLTHCARE |
| 213986 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ |
Discontinued |
No |
No |
AB |
2024/02/06
|
TORRENT |
活性成分:POTASSIUM CITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:15MEQ 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 |
|---|
| 019071 |
003 |
NDA |
UROCIT-K |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
Yes |
Yes |
AB |
2009/12/30
|
MISSION PHARMA |
| 203546 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2014/08/06
|
ZYDUS PHARMS |
| 206813 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2017/09/11
|
STRIDES PHARMA |
| 209758 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2018/03/05
|
TEVA PHARMS USA INC |
| 212779 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2020/01/14
|
ANI PHARMS |
| 212799 |
002 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2020/06/29
|
BIONPHARMA |
| 214420 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2021/02/05
|
ASCENT PHARMS INC |
| 214426 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Prescription |
No |
No |
AB |
2021/02/19
|
HIBROW HLTHCARE |
| 213986 |
003 |
ANDA |
POTASSIUM CITRATE |
POTASSIUM CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
15MEQ |
Discontinued |
No |
No |
AB |
2024/02/06
|
TORRENT |