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 |
|---|
| 2012/12/12 |
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 |
|---|
| 2023/05/12 |
SUPPL-15（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-7（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/05/12 |
SUPPL-2（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:RISPERIDONE; 剂型/给药途径:SOLUTION;ORAL; 规格:1MG/ML; 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 |
|---|
| 020588 |
001 |
NDA |
RISPERDAL |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
Yes |
Yes |
AA |
1996/06/10
|
JANSSEN PHARMS |
| 076440 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2009/01/30
|
ANI PHARMS |
| 076904 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Discontinued |
No |
No |
AA |
2009/07/29
|
HIKMA |
| 077719 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Discontinued |
No |
No |
AA |
2009/07/29
|
PHARM ASSOC |
| 078909 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2009/07/29
|
APOZEAL PHARMS |
| 078452 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2009/09/04
|
AUROBINDO PHARMA LTD |
| 079158 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Discontinued |
No |
No |
AA |
2010/12/03
|
LANNETT CO INC |
| 090347 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Discontinued |
No |
No |
AA |
2011/02/07
|
SUN PHARMA CANADA |
| 091384 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2011/05/25
|
AMNEAL PHARMS |
| 079059 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2012/12/12
|
TRIS PHARMA INC |
| 202386 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
SOLUTION;ORAL |
1MG/ML |
Prescription |
No |
No |
AA |
2015/01/12
|
CHARTWELL MOLECULAR |