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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2024/10/16 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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
|
NOVITIUM PHARMA |
| 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
|
AMNEAL |
| 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
|
APPCO |
| 217137 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2023/07/07
|
PHARMOBEDIENT |
| 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 |
| 217982 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2025/06/02
|
LANNETT CO INC |
| 219153 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Discontinued |
No |
No |
AB |
2025/06/23
|
BIONPHARMA |
| 219091 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2025/07/09
|
AUROBINDO PHARMA LTD |
| 219863 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
FOR SUSPENSION;ORAL |
40MG/5ML |
Prescription |
No |
No |
AB |
2025/07/24
|
MSN |