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 |
|---|
| 2006/10/16 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 2004/02/13 |
SUPPL-45（补充） |
Approval |
Labeling |
|
|
|
| 2003/05/29 |
SUPPL-43（补充） |
Approval |
Labeling |
|
|
|
| 1997/06/23 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/08/08 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/12/31 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/12/02 |
SUPPL-39（补充） |
Approval |
Labeling |
|
|
|
| 1990/09/11 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/03/09 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/02/18 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/01/24 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/09/16 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/02 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1985/06/21 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/05/17 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/15 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/03 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/17 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/16 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1984/04/09 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/09/30 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/01/24 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1982/11/05 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/09/13 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1981/10/26 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/09/30 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1981/09/30 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/10/24 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/06 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/07/16 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/12 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/16 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/09 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1979/06/08 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/09/29 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/09/29 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1978/09/26 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/03/23 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/08 |
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:INJECTABLE;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 |
|---|
| 016366 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 017464 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
B BRAUN |
| 019480 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1985/09/17
|
HOSPIRA |
| 019635 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1988/03/09
|
B BRAUN |
| 076316 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2004/10/27
|
HAEMONETICS |
| 078177 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2007/04/12
|
FRESENIUS MEDCL |
| 207956 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2017/05/25
|
LABORATORIOS GRIFOLS |
| 207310 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
INJECTABLE;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2017/09/19
|
FRESENIUS KABI USA |