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 |
2018/04/30 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/30 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/26 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/03 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/11/25 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/08/01 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/02/15 |
SUPPL-29(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2004/12/14 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/12/24 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/10/02 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/04/16 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/10/29 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/11/21 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/01/27 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/03/26 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/11/02 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/08/01 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1988/08/01 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/06/12 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/10/07 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/06/17 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/14 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/03/25 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/08/13 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1984/08/01 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/11/10 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1982/07/02 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/04/29 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/02/04 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/02/03 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/01/16 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/09 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB3
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 |
018279 |
001 |
NDA |
K-TAB |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB3 |
Approved Prior to Jan 1, 1982
|
ABBVIE |
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB3
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 |
018279 |
003 |
NDA |
K-TAB |
POTASSIUM CHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB3 |
2013/11/25
|
ABBVIE |