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 |
2020/06/18 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/12 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/02/12 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/03/14 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/06/07 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/02/16 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/02/09 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/08/31 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/01/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/01/17 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/29 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/04/08 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1988/10/21 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/12/11 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/09/04 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
1986/09/04 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/07/25 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/31 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/07/20 |
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:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:100MEQ/40ML (2.5MEQ/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 |
018897 |
002 |
NDA |
SODIUM CHLORIDE 14.6% |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
100MEQ/40ML (2.5MEQ/ML) |
Prescription |
Yes |
Yes |
AP |
1984/07/20
|
HOSPIRA |
212070 |
002 |
ANDA |
SODIUM CHLORIDE 14.6% |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
100MEQ/40ML (2.5MEQ/ML) |
Prescription |
No |
No |
AP |
2021/04/28
|
FRESENIUS KABI USA |
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:400MEQ/100ML (4MEQ/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 |
018897 |
003 |
NDA |
SODIUM CHLORIDE 23.4% |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
400MEQ/100ML (4MEQ/ML) |
Prescription |
Yes |
Yes |
AP |
2020/06/18
|
HOSPIRA |
212070 |
003 |
ANDA |
SODIUM CHLORIDE 23.4% |
SODIUM CHLORIDE |
SOLUTION;INTRAVENOUS |
400MEQ/100ML (4MEQ/ML) |
Prescription |
No |
No |
AP |
2022/02/14
|
FRESENIUS KABI USA |