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 |
2016/02/23 |
SUPPL-220(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/05 |
SUPPL-218(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2006/10/26 |
SUPPL-182(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2005/09/02 |
SUPPL-178(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/08 |
SUPPL-174(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/03 |
SUPPL-173(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/03 |
SUPPL-172(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/03/06 |
SUPPL-170(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/03/03 |
SUPPL-171(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/06/04 |
SUPPL-169(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/29 |
SUPPL-168(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/08/21 |
SUPPL-167(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/08/20 |
SUPPL-165(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/06/11 |
SUPPL-166(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/03/28 |
SUPPL-164(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/29 |
SUPPL-160(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/27 |
SUPPL-159(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/06 |
SUPPL-163(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/03/04 |
SUPPL-162(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/18 |
SUPPL-161(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/14 |
SUPPL-157(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/05/24 |
SUPPL-156(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/01/28 |
SUPPL-152(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/09/10 |
SUPPL-151(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/08/30 |
SUPPL-153(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/02/22 |
SUPPL-148(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/01/11 |
SUPPL-149(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/06/14 |
SUPPL-147(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/10/17 |
SUPPL-145(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/08/31 |
SUPPL-107(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/08/08 |
SUPPL-146(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/07/30 |
SUPPL-142(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/11/26 |
SUPPL-141(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/08/08 |
SUPPL-140(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/02/21 |
SUPPL-139(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/18 |
SUPPL-138(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/11/29 |
SUPPL-111(补充) |
Approval |
Labeling |
|
|
|
1985/11/29 |
SUPPL-110(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/11/07 |
SUPPL-133(补充) |
Approval |
Labeling |
|
|
|
1985/10/29 |
SUPPL-109(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/26 |
SUPPL-125(补充) |
Approval |
Labeling |
|
|
|
1985/10/26 |
SUPPL-121(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/09/30 |
SUPPL-132(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/09/26 |
SUPPL-115(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/27 |
SUPPL-130(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/21 |
SUPPL-135(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/10 |
SUPPL-134(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/05/03 |
SUPPL-122(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/01/18 |
SUPPL-120(补充) |
Approval |
Labeling |
|
|
|
1985/01/18 |
SUPPL-119(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/01/08 |
SUPPL-106(补充) |
Approval |
Labeling |
|
|
|
1985/01/08 |
SUPPL-105(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/11/28 |
SUPPL-108(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/22 |
SUPPL-116(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/17 |
SUPPL-101(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/10 |
SUPPL-92(补充) |
Approval |
Labeling |
|
|
|
1984/10/10 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/09/25 |
SUPPL-102(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/06/14 |
SUPPL-103(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/04/09 |
SUPPL-104(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/21 |
SUPPL-100(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/01 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/02/17 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/12/08 |
SUPPL-97(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/09/19 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/08/31 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/06/06 |
SUPPL-94(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/02/15 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/01/25 |
SUPPL-93(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/01/17 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/26 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/08 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/08 |
SUPPL-75(补充) |
Approval |
Labeling |
|
|
|
1982/06/09 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/02/22 |
SUPPL-86(补充) |
Approval |
Labeling |
|
|
|
1982/02/01 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/01/08 |
SUPPL-84(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/10/21 |
SUPPL-81(补充) |
Approval |
Labeling |
|
|
|
1981/10/21 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/10/07 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/09/16 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/07/31 |
SUPPL-78(补充) |
Approval |
Labeling |
|
|
|
1981/07/31 |
SUPPL-77(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/07/16 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/03/02 |
SUPPL-76(补充) |
Approval |
Labeling |
|
|
|
1981/03/02 |
SUPPL-74(补充) |
Approval |
Labeling |
|
|
|
1981/03/02 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/01/07 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/09/15 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/14 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/04/16 |
SUPPL-63(补充) |
Approval |
Labeling |
|
|
|
1980/04/16 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/04/08 |
SUPPL-68(补充) |
Approval |
Labeling |
|
|
|
1980/01/22 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/12/03 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/12/03 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/11/29 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/11/27 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/10 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/17 |
SUPPL-58(补充) |
Approval |
Labeling |
|
|
|
1979/03/27 |
SUPPL-51(补充) |
Approval |
Labeling |
|
|
|
1979/03/27 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/03/27 |
SUPPL-47(补充) |
Approval |
Labeling |
|
|
|
1979/03/27 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/16 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/06 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/01 |
SUPPL-57(补充) |
Approval |
Supplement |
STANDARD
|
|
|
1978/11/24 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/11/01 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/10/17 |
SUPPL-55(补充) |
Approval |
Labeling |
|
|
|
1978/09/13 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/08 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/08 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/08 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/15 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/03 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/07/11 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/06/26 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/06/05 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1978/06/05 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/06/05 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/05/31 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/04/06 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1978/03/15 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/02/17 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1978/02/13 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/02/09 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/02/08 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1978/01/23 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/01/17 |
SUPPL-53(补充) |
Approval |
Labeling |
|
|
|
1978/01/17 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/09/28 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1977/09/28 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1977/09/09 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/09/09 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/09/09 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1977/09/09 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1977/04/29 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/23 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/11/08 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/10/15 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1976/04/06 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1976/04/06 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/03/01 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1975/11/20 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/10/29 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/09/03 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/05/20 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/05/20 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1971/02/12 |
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: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 |