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 |
|---|
| 2008/10/06 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2025/07/11 |
SUPPL-12（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2020/03/03 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/11/08 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
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:CETIRIZINE HYDROCHLORIDE; 剂型/给药途径:SOLUTION;ORAL; 规格:5MG/5ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 077279 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Discontinued |
No |
No |
AA |
2008/05/27
|
TEVA PHARMS |
| 078398 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
Yes |
AA |
2008/06/17
|
PADAGIS US |
| 078412 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2008/06/18
|
PHARM ASSOC |
| 076601 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2008/06/20
|
TARO |
| 078488 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2008/10/06
|
BIONPHARMA |
| 078870 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2009/04/27
|
APOZEAL PHARMS |
| 090766 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2009/10/07
|
AMNEAL PHARMS |
| 090191 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2009/11/12
|
BAJAJ |
| 078876 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE |
CETIRIZINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2012/05/11
|
CHARTWELL MOLECULAR |