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 |
2018/01/04 |
SUPPL-64(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/05/14 |
SUPPL-63(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/11/27 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/08/02 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/01/23 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/01/23 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/01/12 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/10/23 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/03/15 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/03/15 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
2001/03/15 |
SUPPL-46(补充) |
Approval |
Labeling |
|
|
|
2001/03/15 |
SUPPL-44(补充) |
Approval |
Labeling |
|
|
|
2001/03/15 |
SUPPL-40(补充) |
Approval |
Labeling |
|
|
|
2001/03/15 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
2001/03/15 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1997/07/14 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/02/24 |
SUPPL-36(补充) |
Approval |
Labeling |
|
|
|
1984/03/22 |
SUPPL-31(补充) |
Approval |
Efficacy |
|
|
|
1984/03/22 |
SUPPL-28(补充) |
Approval |
Efficacy |
|
|
|
1981/04/06 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1980/05/20 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1978/06/20 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1961/02/21 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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:TRANYLCYPROMINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 治疗等效代码:AB
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 |
012342 |
003 |
NDA |
PARNATE |
TRANYLCYPROMINE SULFATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
Yes |
Yes |
AB |
1985/08/16
|
CONCORDIA |
040640 |
001 |
ANDA |
TRANYLCYPROMINE SULFATE |
TRANYLCYPROMINE SULFATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2006/06/29
|
STRIDES PHARMA |
206856 |
001 |
ANDA |
TRANYLCYPROMINE SULFATE |
TRANYLCYPROMINE SULFATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2018/04/17
|
NOVITIUM PHARMA |
213503 |
001 |
ANDA |
TRANYLCYPROMINE SULFATE |
TRANYLCYPROMINE SULFATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2022/06/27
|
CROSSMEDIKA SA |