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 |
2023/09/14 |
ORIG-1(原始申请) |
Approval |
|
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:FAMOTIDINE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:40MG/5ML 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 |
091020 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2010/05/27
|
NAVINTA LLC |
090440 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2010/06/29
|
LUPIN LTD |
201695 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2012/12/17
|
NOVEL LABS INC |
201995 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2014/05/30
|
AKORN |
215043 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
Yes |
AB |
2021/04/20
|
NOVITIUM PHARMA |
216427 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2022/08/04
|
AMNEALS PHARMS |
216400 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/05/15
|
ALKEM LABS LTD |
217655 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/06/16
|
UPSHER SMITH LABS |
217137 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/07/07
|
CARNEGIE |
217330 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/08/17
|
ANNORA PHARMA |
217842 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/09/14
|
MICRO LABS |
217529 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/09/18
|
AJANTA PHARMA LTD |
217605 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2024/01/16
|
UNICHEM |
218344 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2024/10/16
|
EPIC PHARMA LLC |