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 |
|---|
| 2021/09/22 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/05/20 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2001/04/16 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:INJECTABLE;INJECTION 规格:10MG/ML 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 |
|---|
| 075486 |
001 |
ANDA |
FAMOTIDINE PRESERVATIVE FREE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
Yes |
AP |
2001/04/16
|
HIKMA |
| 075488 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
Yes |
AP |
2001/04/16
|
HIKMA |
| 075622 |
001 |
ANDA |
FAMOTIDINE PRESERVATIVE FREE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/16
|
SAGENT |
| 075651 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/16
|
SAGENT |
| 075684 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/16
|
SAGENT |
| 075709 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/16
|
FRESENIUS KABI USA |
| 075813 |
001 |
ANDA |
FAMOTIDINE PRESERVATIVE FREE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/16
|
FRESENIUS KABI USA |
| 075825 |
001 |
ANDA |
FAMOTIDINE PRESERVATIVE FREE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2001/04/17
|
SAGENT |
| 078641 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2008/06/25
|
MYLAN LABS LTD |
| 078642 |
001 |
ANDA |
FAMOTIDINE PRESERVATIVE FREE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2008/06/25
|
MYLAN LABS LTD |
| 215828 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
INJECTABLE;INJECTION |
10MG/ML |
Discontinued |
No |
No |
AP |
2022/11/22
|
ZYDUS PHARMS |
