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 |
|---|
| 1957/12/03 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
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 |
|---|
| 2009/09/16 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/04/02 |
SUPPL-29（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
N/A
|
|
|
| 2004/01/16 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/02/23 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1998/05/06 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/02/27 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1992/03/30 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/11/16 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/08/11 |
SUPPL-19（补充） |
Approval |
Efficacy-Rx To OTC Switch |
|
|
|
| 1988/06/30 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1986/05/29 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1985/09/16 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1985/07/31 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1984/04/11 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1984/04/02 |
SUPPL-13（补充） |
Approval |
Efficacy |
|
|
|
| 1984/04/02 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Formulation |
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: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
|
PHARMOBEDIENT |
| 040649 |
001 |
ANDA |
PROMETHAZINE DM |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
Prescription |
No |
Yes |
AA |
2006/02/14
|
PAI HOLDINGS |
| 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
|
COSETTE |
