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 |
|---|
| 2019/08/12 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/08/12 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/11/20 |
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:BUSULFAN 剂型/给药途径:INJECTABLE;INJECTION 规格:6MG/ML 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 |
|---|
| 020954 |
001 |
NDA |
BUSULFEX |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
Yes |
Yes |
AP |
1999/02/04
|
OTSUKA PHARM |
| 202259 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Discontinued |
No |
No |
AP |
2015/12/22
|
AM REGENT |
| 207050 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2017/03/24
|
PHARMASCIENCE INC |
| 208536 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2017/11/20
|
MYLAN INSTITUTIONAL |
| 209580 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2017/12/18
|
AMNEAL |
| 205672 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2018/07/31
|
HOSPIRA |
| 205106 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Discontinued |
No |
No |
AP |
2018/09/21
|
ARTHUR GRP |
| 207794 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Discontinued |
No |
No |
AP |
2019/01/14
|
NEXUS |
| 210148 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2019/02/22
|
ACCORD HLTHCARE INC |
| 210931 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2019/04/18
|
SHILPA |
| 210448 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2019/05/07
|
APOTEX |
| 212127 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2020/10/23
|
MEITHEAL |
| 215102 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2024/06/25
|
EUGIA PHARMA |
| 215235 |
001 |
ANDA |
BUSULFAN |
BUSULFAN |
INJECTABLE;INJECTION |
6MG/ML |
Prescription |
No |
No |
AP |
2024/09/11
|
PRINSTON INC |