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 |
|---|
| 2023/04/28 |
ORIG-1（原始申请） |
Approval |
|
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:BENDAMUSTINE HYDROCHLORIDE 剂型/给药途径:POWDER;IV (INFUSION) 规格:25MG/VIAL 治疗等效代码:AP
| 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 |
|---|
| 205476 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
None (Tentative Approval) |
No |
No |
AP |
--
|
INNOPHARMA LICENSING |
| 022249 |
002 |
NDA |
TREANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2009/05/01
|
CEPHALON |
| 205376 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/07
|
DR REDDYS |
| 205574 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/07
|
ACCORD HLTHCARE |
| 205447 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2023/02/14
|
BRECKENRIDGE |
| 204104 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Discontinued |
No |
No |
AP |
2023/04/28
|
MYLAN LABS LTD |
| 204230 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
APOTEX |
| 211001 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
KINDOS |
| 214739 |
001 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
25MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
EUGIA PHARMA |
活性成分:BENDAMUSTINE HYDROCHLORIDE 剂型/给药途径:POWDER;IV (INFUSION) 规格:100MG/VIAL 治疗等效代码:AP
| 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 |
|---|
| 204086 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
None (Tentative Approval) |
No |
No |
AP |
--
|
HOSPIRA INC |
| 205476 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
None (Tentative Approval) |
No |
No |
AP |
--
|
INNOPHARMA LICENSING |
| 022249 |
001 |
NDA |
TREANDA |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2008/03/20
|
CEPHALON |
| 205574 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/07
|
ACCORD HLTHCARE |
| 205376 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/07
|
DR REDDYS |
| 205447 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/02/14
|
BRECKENRIDGE |
| 204104 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Discontinued |
No |
No |
AP |
2023/04/28
|
MYLAN LABS LTD |
| 204230 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
APOTEX |
| 211001 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
KINDOS |
| 214739 |
002 |
ANDA |
BENDAMUSTINE HYDROCHLORIDE |
BENDAMUSTINE HYDROCHLORIDE |
POWDER;IV (INFUSION) |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/05
|
EUGIA PHARMA |