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 |
2022/12/07 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2020/01/27 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2019/05/29 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/23 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/07/28 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/05/04 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/09/14 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1997/12/29 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/30 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/07/15 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/02/18 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/12/07 |
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;INJECTION 规格:900MG/100ML 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 |
016677 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
019465 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1985/07/15
|
HOSPIRA |
020178 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1992/12/07
|
BAXTER HLTHCARE |
211968 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2020/04/23
|
NEPHRON |
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:450MG/50ML (9MG/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 |
016677 |
003 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
018803 |
003 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
019465 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
No |
AP |
1985/07/15
|
HOSPIRA |
020178 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
No |
AP |
1992/12/07
|
BAXTER HLTHCARE |
211968 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
No |
No |
AP |
2020/04/23
|
NEPHRON |