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 |
2022/12/02 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/11/03 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/21 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2007/01/16 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
2005/10/18 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1997/03/06 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1994/11/17 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/06/25 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1991/03/19 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1991/02/04 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1991/01/25 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/12/18 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1987/10/29 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/12/17 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/03/20 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/03/20 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/25 |
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 CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MEQ/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 |
080205 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2MEQ/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
085870 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2MEQ/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
B BRAUN |
088901 |
001 |
ANDA |
POTASSIUM CHLORIDE IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2MEQ/ML |
Prescription |
No |
No |
AP |
1985/01/25
|
FRESENIUS KABI USA |
088908 |
001 |
ANDA |
POTASSIUM CHLORIDE IN PLASTIC CONTAINER |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2MEQ/ML |
Prescription |
No |
No |
AP |
1985/01/25
|
FRESENIUS KABI USA |
217704 |
001 |
ANDA |
POTASSIUM CHLORIDE |
POTASSIUM CHLORIDE |
INJECTABLE;INJECTION |
2MEQ/ML |
Prescription |
No |
No |
AP |
2023/08/14
|
NEXUS PHARMS |