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-169（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/03/09 |
SUPPL-160（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2016/03/03 |
SUPPL-151（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/05/13 |
SUPPL-150（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/12/22 |
SUPPL-148（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/05 |
SUPPL-149（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/09/11 |
SUPPL-147（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2005/08/26 |
SUPPL-139（补充） |
Approval |
Supplement |
STANDARD
|
|
|
| 2005/05/23 |
SUPPL-137（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/07/17 |
SUPPL-131（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/09/16 |
SUPPL-128（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/04/03 |
SUPPL-124（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/08/14 |
SUPPL-126（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/11/24 |
SUPPL-125（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/12/31 |
SUPPL-123（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/06/10 |
SUPPL-121（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/04/29 |
SUPPL-122（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/11/14 |
SUPPL-119（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/10/11 |
SUPPL-120（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/09/27 |
SUPPL-118（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/09/30 |
SUPPL-116（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/02/18 |
SUPPL-117（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/06/01 |
SUPPL-111（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/01/06 |
SUPPL-115（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/11/23 |
SUPPL-110（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/03/26 |
SUPPL-109（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/02/15 |
SUPPL-106（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/05/24 |
SUPPL-108（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/03/23 |
SUPPL-107（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-105（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/01/12 |
SUPPL-104（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/01/10 |
SUPPL-102（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/06/14 |
SUPPL-103（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/25 |
SUPPL-100（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/05/28 |
SUPPL-99（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/04/27 |
SUPPL-101（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/02/27 |
SUPPL-96（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/10/30 |
SUPPL-89（补充） |
Approval |
Labeling |
|
|
|
| 1985/10/30 |
SUPPL-88（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-83（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-82（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/06/13 |
SUPPL-91（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/15 |
SUPPL-95（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/15 |
SUPPL-94（补充） |
Approval |
Labeling |
|
|
|
| 1985/01/24 |
SUPPL-80（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/09/22 |
SUPPL-90（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/09/21 |
SUPPL-87（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/16 |
SUPPL-81（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/28 |
SUPPL-86（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/07/11 |
SUPPL-75（补充） |
Approval |
Labeling |
|
|
|
| 1982/06/03 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/16 |
SUPPL-70（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/08 |
SUPPL-77（补充） |
Approval |
Labeling |
|
|
|
| 1982/02/16 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/12/21 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/20 |
SUPPL-74（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/09 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/08/26 |
SUPPL-69（补充） |
Approval |
Labeling |
|
|
|
| 1981/08/06 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/06/29 |
SUPPL-64（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/05/20 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/04/23 |
SUPPL-65（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/04/16 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/21 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/07 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/07/31 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/28 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/18 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/05/30 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/05/30 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/25 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/22 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/02 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/03/23 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/03 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/10/20 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/09/08 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/07 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/02 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/06/20 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/04/25 |
SUPPL-43（补充） |
Approval |
Labeling |
|
|
|
| 1978/03/24 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/03/22 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/28 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/01/11 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/01/11 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/01/11 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/14 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/06/06 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/02/07 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/10/20 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 1976/10/18 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 1976/07/13 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1976/07/01 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/06/17 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/11 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/01/05 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/01/02 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1975/09/25 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/09/23 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/09/17 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/07/10 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1970/12/09 |
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 |
