药品注册申请号:016694
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Yes Yes AP 1971/01/25 Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/08/05 SUPPL 121 Approval Labeling STANDARD
2016/01/15 SUPPL 123 Approval Manufacturing (CMC) STANDARD
2014/12/22 SUPPL 119 Approval Labeling STANDARD
2014/05/23 SUPPL 120 Approval Manufacturing (CMC) STANDARD
2006/07/10 SUPPL 113 Approval Labeling
2005/02/04 SUPPL 108 Approval Labeling
2003/05/15 SUPPL 107 Approval Labeling
2001/08/29 SUPPL 105 Approval Manufacturing (CMC) STANDARD
2001/08/14 SUPPL 104 Approval Manufacturing (CMC) STANDARD
2001/08/14 SUPPL 103 Approval Labeling
2000/01/28 SUPPL 102 Approval Manufacturing (CMC) STANDARD
1999/09/15 SUPPL 98 Approval Labeling
1999/07/30 SUPPL 101 Approval Manufacturing (CMC) STANDARD
1998/05/27 SUPPL 100 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 99 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1994/03/17 SUPPL 95 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 97 Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 92 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 90 Approval Manufacturing (CMC) STANDARD
1990/07/30 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL 88 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 87 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 86 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL 81 Approval Manufacturing (CMC) STANDARD
1985/04/10 SUPPL 82 Approval Labeling
1985/01/24 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1984/06/07 SUPPL 77 Approval Labeling
1984/06/07 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1984/04/13 SUPPL 79 Approval Labeling
1984/03/16 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL 68 Approval Labeling
1982/06/03 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1982/03/23 SUPPL 58 Approval Labeling
1982/03/23 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1982/02/16 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1981/11/09 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 60 Approval Labeling
1981/06/29 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1980/12/15 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1980/12/15 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1980/03/18 SUPPL 43 Approval Labeling
1980/03/18 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1978/10/20 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1978/10/12 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1978/08/07 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1978/08/02 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1978/06/20 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1978/04/25 SUPPL 34 Approval Labeling
1978/03/24 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1978/03/22 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1977/06/06 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1977/02/07 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1976/10/18 SUPPL 19 Approval Labeling
1976/07/13 SUPPL 25 Approval Labeling
1976/07/01 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1976/06/17 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1976/05/11 SUPPL 17 Approval Labeling
1976/01/05 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1976/01/02 SUPPL 22 Approval Labeling
1975/09/23 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1975/09/17 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1975/07/10 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1975/06/16 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1971/01/25 ORIG 1 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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:10GM/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RLDRSTE Code产品号批准日期申请人
016694 001 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018080 001 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019626 004 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP 1988/02/02 B BRAUN
209448 001 ANDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription No No AP 2018/07/16 FRESENIUS KABI USA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database