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 |
|---|
| 2016/02/24 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/12/10 |
SUPPL-75（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/09/28 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/09/30 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/09/14 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/11/14 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/03/26 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/05/24 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/10/30 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/18 |
SUPPL-56（补充） |
Approval |
Labeling |
|
|
|
| 1985/01/24 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/01/24 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/28 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/12/22 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/12/22 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/12/22 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/06/07 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/05/07 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/06 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1982/04/06 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/06 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1982/04/06 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/16 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/08/06 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/06/29 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/06/10 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/02/23 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/22 |
SUPPL-38（补充） |
Approval |
Labeling |
|
|
|
| 1980/07/31 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/02 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1980/06/02 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/19 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/13 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/13 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/13 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/05/29 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/04/30 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/02/14 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/02/08 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1978/07/05 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/10/05 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/09/20 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/07/12 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/05/19 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/04/26 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/04/06 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/12/17 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/11/10 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/11/10 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/10/06 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/10/06 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1976/09/28 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/08/13 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/07/13 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/06/16 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/07/07 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1974/12/31 |
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;IRRIGATION 规格:900MG/100ML 治疗等效代码:AT
| 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 |
|---|
| 016733 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
B BRAUN |
| 017427 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 017514 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
Yes |
No |
AT |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 017867 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 018314 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 213688 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;IRRIGATION |
900MG/100ML |
Prescription |
No |
No |
AT |
2024/06/24
|
FRESENIUS KABI USA |