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 |
|---|
| 2014/09/08 |
SUPPL-153（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2006/04/10 |
SUPPL-123（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/18 |
SUPPL-119（补充） |
Approval |
Labeling |
|
|
|
| 1999/03/31 |
SUPPL-118（补充） |
Approval |
Labeling |
|
|
|
| 1998/12/01 |
SUPPL-117（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/08/20 |
SUPPL-115（补充） |
Approval |
Labeling |
|
|
|
| 1997/06/11 |
SUPPL-116（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/03/28 |
SUPPL-114（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/29 |
SUPPL-110（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/27 |
SUPPL-109（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/06 |
SUPPL-113（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/03/04 |
SUPPL-112（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/08/18 |
SUPPL-111（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/08/14 |
SUPPL-107（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/01/28 |
SUPPL-103（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/09/10 |
SUPPL-102（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/08/30 |
SUPPL-104（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/22 |
SUPPL-99（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/01/11 |
SUPPL-100（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/08/31 |
SUPPL-73（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/30 |
SUPPL-96（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/11/26 |
SUPPL-95（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/08/08 |
SUPPL-94（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/01/31 |
SUPPL-89（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/11/29 |
SUPPL-77（补充） |
Approval |
Labeling |
|
|
|
| 1985/11/29 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/10/29 |
SUPPL-75（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/10/26 |
SUPPL-85（补充） |
Approval |
Labeling |
|
|
|
| 1985/10/26 |
SUPPL-83（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/09/30 |
SUPPL-90（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/09/26 |
SUPPL-79（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/27 |
SUPPL-86（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/06/10 |
SUPPL-91（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/05/03 |
SUPPL-84（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/11/28 |
SUPPL-74（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/22 |
SUPPL-80（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/17 |
SUPPL-70（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/10 |
SUPPL-64（补充） |
Approval |
Labeling |
|
|
|
| 1984/10/10 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/06/14 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/04/09 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/21 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/01 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/17 |
SUPPL-66（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/12/08 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/08/31 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/06/06 |
SUPPL-65（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/02/15 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/08/31 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1982/07/26 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/07/08 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/06/09 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/05 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/01 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/01/08 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/10/21 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1981/10/21 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/10/07 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/03/02 |
SUPPL-51（补充） |
Approval |
Labeling |
|
|
|
| 1981/03/02 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 1981/03/02 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/07 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/09/15 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/10 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/04/08 |
SUPPL-43（补充） |
Approval |
Labeling |
|
|
|
| 1980/02/12 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/01/22 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/03 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/12/03 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/11/29 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/11/27 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/10 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/07/17 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 1979/02/06 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/02/01 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/01/05 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/22 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/22 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/08 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/07 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 1978/10/11 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/10/10 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1978/10/10 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/15 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/02 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/06/26 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/06/14 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/06/14 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/05/08 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/04/11 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/03/30 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/13 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/08 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1978/01/23 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/09/28 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1977/05/20 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/05/03 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/04/29 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/11/29 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1976/11/08 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/11/20 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/11/03 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/10/17 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1975/10/15 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/08/13 |
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:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;450MG/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 |
|---|
| 016683 |
001 |
NDA |
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 017607 |
001 |
NDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 019631 |
009 |
NDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
1988/02/24
|
B BRAUN |
| 211276 |
001 |
ANDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
2020/09/15
|
FRESENIUS KABI USA |
