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 |
|---|
| 2022/12/27 |
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:CARMUSTINE 剂型/给药途径:INJECTABLE;INJECTION 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 |
|---|
| 017422 |
001 |
NDA |
BICNU |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
AVET LIFESCIENCES |
| 210179 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2018/09/11
|
NAVINTA LLC |
| 211229 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2018/10/16
|
AMNEAL |
| 209278 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2019/04/02
|
PENN LIFE |
| 213207 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2020/10/22
|
DR REDDYS |
| 211202 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2021/03/12
|
HENGRUI PHARMA |
| 213460 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2021/08/02
|
MEITHEAL |
| 211011 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Discontinued |
No |
No |
AP |
2022/06/21
|
INGENUS PHARMS LLC |
| 214117 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Discontinued |
No |
No |
AP |
2022/12/27
|
ACCORD HLTHCARE |
| 215368 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Discontinued |
No |
No |
AP |
2023/03/03
|
NORVIUM BIOSCIENCE |
| 214814 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/05/11
|
MSN |
| 215730 |
001 |
ANDA |
CARMUSTINE |
CARMUSTINE |
INJECTABLE;INJECTION |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/10/20
|
ALEMBIC |