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 |
|---|
| 2008/04/15 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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 |
|---|
| 2021/03/04 |
SUPPL-15（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/07/27 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/10/27 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/02/22 |
SUPPL-9（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2010/03/31 |
SUPPL-8（补充） |
Approval |
Efficacy-Labeling Change With Clinical Data |
STANDARD
|
|
|
| 2009/12/01 |
SUPPL-2（补充） |
Approval |
Efficacy-New Patient Population |
PRIORITY
|
|
|
| 2009/06/17 |
SUPPL-1（补充） |
Approval |
Efficacy-Labeling Change With Clinical Data |
UNKNOWN
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
>>>活性成分:OLOPATADINE HYDROCHLORIDE; 剂型/给药途径:SPRAY, METERED;NASAL; 规格:0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<
| 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 |
|---|
| 021861 |
001 |
NDA |
PATANASE |
OLOPATADINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2008/04/15
|
NOVARTIS |
