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 |
|---|
| 2020/06/26 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/11/03 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/05/15 |
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:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE, LIPOSOMAL;INJECTION 规格:20MG/10ML (2MG/ML) 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 |
|---|
| 050718 |
001 |
NDA |
DOXIL (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
Yes |
No |
AB |
1995/11/17
|
BAXTER HLTHCARE CORP |
| 203263 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
Yes |
AB |
2013/02/04
|
SUN PHARM |
| 208657 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
No |
AB |
2017/05/15
|
DR REDDYS |
| 212299 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
No |
AB |
2020/09/10
|
ZYDUS LIFESCIENCES |
| 207228 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
No |
AB |
2021/10/12
|
AYANA PHARMA LTD |
| 212219 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
No |
AB |
2022/10/19
|
BAXTER HLTHCARE CORP |
| 215178 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
20MG/10ML (2MG/ML) |
Prescription |
No |
No |
AB |
2024/07/16
|
LUPIN |
活性成分:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE, LIPOSOMAL;INJECTION 规格:50MG/25ML (2MG/ML) 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 |
|---|
| 050718 |
002 |
NDA |
DOXIL (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
Yes |
No |
AB |
2000/06/13
|
BAXTER HLTHCARE CORP |
| 203263 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
Yes |
AB |
2013/02/04
|
SUN PHARM |
| 208657 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AB |
2017/05/15
|
DR REDDYS |
| 212299 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AB |
2020/09/10
|
ZYDUS LIFESCIENCES |
| 207228 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AB |
2021/10/12
|
AYANA PHARMA LTD |
| 212219 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AB |
2022/10/19
|
BAXTER HLTHCARE CORP |
| 215178 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE, LIPOSOMAL;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AB |
2024/07/16
|
LUPIN |
