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 |
2019/08/05 |
SUPPL-75(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/28 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/01/26 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/02/03 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/11 |
SUPPL-68(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/01/27 |
SUPPL-65(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/04/03 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/14 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/02/01 |
SUPPL-58(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/11/24 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/02/04 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/29 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/30 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/02/18 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/04/29 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/03/26 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/02/15 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/05/24 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/07/26 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/07/25 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/05/28 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/02/27 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/28 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/28 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/13 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/04/15 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/01/26 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
|
1985/01/24 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/01/19 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1984/09/22 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/16 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/02/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/07/11 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
1983/07/11 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1982/11/22 |
SUPPL-30(补充) |
Approval |
Labeling |
|
|
|
1982/11/22 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/06/03 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/04/16 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/02/16 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/12/21 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/11/20 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/09/03 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1981/09/03 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/08/26 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1981/06/29 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/04/16 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/01/21 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/08/07 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/31 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/28 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/18 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/05/30 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/25 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/08/02 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/06/14 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/02 |
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:MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/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 |
017378 |
001 |
NDA |
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
017378 |
002 |
NDA |
PLASMA-LYTE A IN PLASTIC CONTAINER |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
Yes |
Yes |
AP |
1982/11/22
|
BAXTER HLTHCARE |
215371 |
001 |
ANDA |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
No |
No |
AP |
2022/06/08
|
FRESENIUS KABI USA |
215370 |
001 |
ANDA |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
No |
No |
AP |
2022/06/29
|
FRESENIUS KABI USA |
活性成分:MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/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 |
017378 |
001 |
NDA |
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
017378 |
002 |
NDA |
PLASMA-LYTE A IN PLASTIC CONTAINER |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
Yes |
Yes |
AP |
1982/11/22
|
BAXTER HLTHCARE |
215371 |
001 |
ANDA |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
No |
No |
AP |
2022/06/08
|
FRESENIUS KABI USA |
215370 |
001 |
ANDA |
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 |
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE |
INJECTABLE;INJECTION |
30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML |
Prescription |
No |
No |
AP |
2022/06/29
|
FRESENIUS KABI USA |