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 |
2014/09/29 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2006/10/19 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
2004/08/06 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
1997/06/23 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/08 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/12/31 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/09/11 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/03/09 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/02/18 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/30 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/09/16 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/24 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1985/06/21 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/05/17 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/04/03 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/17 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/16 |
SUPPL-34(补充) |
Approval |
Labeling |
|
|
|
1984/04/09 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/09/30 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/01/24 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1982/11/05 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/06/28 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1982/06/28 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/10/26 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/09/30 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1981/09/30 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/10/24 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/08/06 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/16 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/12 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/16 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/09 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1979/06/08 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/03/14 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1979/03/12 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/11/02 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1978/11/02 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/10/12 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/04/28 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/10/21 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/08/19 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/05/25 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/12/06 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1973/12/21 |
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 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/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 |
016673 |
001 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
016730 |
001 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
B BRAUN |
019466 |
001 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
1985/07/15
|
HOSPIRA |
019479 |
001 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
1985/09/17
|
HOSPIRA |
019626 |
002 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
1988/02/02
|
B BRAUN |
020179 |
001 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
5GM/100ML |
Prescription |
Yes |
Yes |
AP |
1992/12/07
|
BAXTER HLTHCARE |
活性成分:DEXTROSE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/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 |
016730 |
002 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
B BRAUN |
016367 |
002 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
016673 |
003 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
1985/10/30
|
BAXTER HLTHCARE |
020179 |
002 |
NDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
1992/12/07
|
BAXTER HLTHCARE |
207449 |
001 |
ANDA |
DEXTROSE 5% IN PLASTIC CONTAINER |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2016/10/21
|
FRESENIUS KABI USA |
217263 |
001 |
ANDA |
DEXTROSE 5% |
DEXTROSE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2024/04/08
|
AM REGENT |