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 |
|---|
| 2022/07/26 |
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:BORTEZOMIB 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:3.5MG/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 |
|---|
| 021602 |
001 |
NDA |
VELCADE |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2003/05/13
|
TAKEDA PHARMS USA |
| 205533 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
APOTEX |
| 205857 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Discontinued |
No |
No |
AP |
2022/05/02
|
TEVA PHARMS USA |
| 208392 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
PHARMASCIENCE INC |
| 209659 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
FRESENIUS KABI USA |
| 210204 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
ZYDUS PHARMS |
| 210824 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
QILU PHARM HAINAN |
| 212825 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
EUGIA PHARMA |
| 213823 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/05/02
|
BAXTER HLTHCARE CORP |
| 215011 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
JIANGSU HANSOH PHARM |
| 212958 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
MEITHEAL |
| 208460 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
HOSPIRA |
| 209622 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
MSN |
| 202963 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
DR REDDYS |
| 203654 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/07/26
|
SANDOZ |
| 204405 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Discontinued |
No |
No |
AP |
2022/07/26
|
ACCORD HLTHCARE |
| 211898 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2022/10/11
|
RELIANCE LIFE SCI |
| 205160 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Discontinued |
No |
No |
AP |
2022/10/31
|
NORVIUM BIOSCIENCE |
| 216912 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Discontinued |
No |
No |
AP |
2023/09/26
|
SCINOPHARM TAIWAN |
| 212204 |
001 |
ANDA |
BORTEZOMIB |
BORTEZOMIB |
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
3.5MG/VIAL |
Prescription |
No |
No |
AP |
2024/05/03
|
HETERO LABS LTD VI |