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 |
|---|
| 2014/10/24 |
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 |
|---|
| 2019/05/17 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/01/04 |
SUPPL-1（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:AZELASTINE HYDROCHLORIDE; 剂型/给药途径:SPRAY, METERED;NASAL; 规格:0.137MG/SPRAY; 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 |
|---|
| 077954 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
Yes |
AB |
2009/04/30
|
APOTEX INC |
| 090423 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Discontinued |
No |
No |
AB |
2012/05/23
|
SUN PHARM |
| 091444 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Discontinued |
No |
No |
AB |
2014/10/24
|
HIKMA |
| 090176 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Discontinued |
No |
No |
AB |
2015/07/28
|
BIONPHARMA |
| 202609 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Discontinued |
No |
No |
AB |
2017/03/17
|
PADAGIS US |
| 091409 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
No |
AB |
2017/08/14
|
ZYDUS PHARMS |
| 208156 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
No |
AB |
2017/08/18
|
ALKEM LABS LTD |
| 204660 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
No |
AB |
2017/08/28
|
AMNEAL |
| 207610 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
No |
AB |
2019/05/17
|
EPIC PHARMA LLC |
| 212289 |
001 |
ANDA |
AZELASTINE HYDROCHLORIDE |
AZELASTINE HYDROCHLORIDE |
SPRAY, METERED;NASAL |
0.137MG/SPRAY |
Prescription |
No |
No |
AB |
2020/05/08
|
AUROBINDO PHARMA LTD |