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 |
2015/01/26 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/12 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/02/12 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/09/12 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/02/16 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/31 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/01/17 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/29 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/02/10 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1988/03/24 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1986/02/25 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/03/15 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/22 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/06/14 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/01/25 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/01/17 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/10/29 |
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: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: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 |