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 |
|---|
| 2020/05/28 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/12/17 |
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:BUSPIRONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:30MG 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 |
|---|
| 076008 |
001 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2001/06/28
|
MYLAN |
| 075022 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2004/03/25
|
TEVA |
| 078302 |
001 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2007/12/17
|
OXFORD PHARMS |
| 078246 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/02/27
|
AUROBINDO PHARMA LTD |
| 078888 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2014/02/07
|
ZYDUS PHARMS |
| 202330 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2014/08/25
|
STRIDES PHARMA |
| 202557 |
005 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2014/12/30
|
ACCORD HLTHCARE |
| 204582 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2015/09/18
|
HERITAGE PHARMA |
| 202087 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2015/12/16
|
AIPING PHARM INC |
| 208829 |
005 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2017/05/24
|
AMNEAL PHARMS CO |
| 209696 |
005 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2018/05/03
|
INVENTIA HLTHCARE |
| 208972 |
005 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2019/04/16
|
EPIC PHARMA LLC |
| 210907 |
004 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2019/11/14
|
UNICHEM |
| 075521 |
005 |
ANDA |
BUSPIRONE HYDROCHLORIDE |
BUSPIRONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2021/03/16
|
RUBICON |