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 |
|---|
| 2006/02/14 |
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:DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:15MG/5ML;6.25MG/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 |
|---|
| 011265 |
002 |
NDA |
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
Yes |
No |
AA |
1984/04/02
|
ANI PHARMS |
| 088864 |
001 |
ANDA |
PROMETHAZINE W/ DEXTROMETHORPHAN |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
1985/01/04
|
WOCKHARDT BIO AG |
| 040649 |
001 |
ANDA |
PROMETHAZINE DM |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
No |
Yes |
AA |
2006/02/14
|
SLATE RUN PHARMA |
| 090575 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2011/02/08
|
AMNEAL PHARMS |
| 091687 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2012/06/28
|
TRIS PHARMA INC |