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 |
|---|
| 2020/08/11 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/05/21 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/05/13 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/08 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/11/15 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/11/15 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/02/02 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1992/11/02 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1992/08/11 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1987/09/28 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/09/28 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/06/08 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/14 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/11/29 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/11/29 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/10 |
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:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:90MG/10ML (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 |
|---|
| 018800 |
001 |
NDA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
| 018803 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
| 088912 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
Yes |
AP |
1985/01/10
|
FRESENIUS KABI USA |
| 088911 |
002 |
ANDA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
No |
AP |
1985/05/17
|
FRESENIUS KABI USA |
| 077407 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
Yes |
AP |
2006/08/11
|
TARO |
| 201850 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Discontinued |
No |
No |
AP |
2012/01/20
|
HIKMA |
| 201833 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
No |
AP |
2015/01/07
|
HIKMA |
| 206171 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
No |
AP |
2017/07/21
|
SPECTRA MDCL DEVICES |
| 217535 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
90MG/10ML (9MG/ML) |
Prescription |
No |
No |
AP |
2023/08/23
|
NEXUS PHARMS |
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:180MG/20ML (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 |
|---|
| 018800 |
002 |
NDA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
180MG/20ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
| 018803 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
180MG/20ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
| 088912 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
180MG/20ML (9MG/ML) |
Prescription |
No |
Yes |
AP |
1985/01/10
|
FRESENIUS KABI USA |
| 217535 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
180MG/20ML (9MG/ML) |
Prescription |
No |
No |
AP |
2023/08/23
|
NEXUS PHARMS |
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:270MG/30ML (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 |
|---|
| 018800 |
003 |
NDA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
270MG/30ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
| 088912 |
003 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
270MG/30ML (9MG/ML) |
Prescription |
No |
Yes |
AP |
1985/01/10
|
FRESENIUS KABI USA |
| 088911 |
001 |
ANDA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
270MG/30ML (9MG/ML) |
Prescription |
No |
No |
AP |
1985/02/07
|
FRESENIUS KABI USA |