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 |
|---|
| 2019/05/29 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2016/09/27 |
SUPPL-55（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/06/10 |
SUPPL-54（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/11/01 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/04/06 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/04/06 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 2000/04/06 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/07/02 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1998/12/01 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/08/20 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/06/11 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/27 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/03/04 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/01/24 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/05/31 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/01/05 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/09/23 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/06/21 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1994/02/25 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/02/16 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1992/01/28 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/12/30 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/09/10 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/11/02 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/03/09 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/22 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/01/11 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/09/20 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1989/08/03 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/18 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/02/06 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/11/26 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/08/08 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/05/27 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/01/17 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1985/07/15 |
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 |
