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 |
|---|
| 2021/05/28 |
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:MELPHALAN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/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 |
|---|
| 090270 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2009/06/09
|
MYLAN INSTITUTIONAL |
| 090303 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2010/10/28
|
HIKMA |
| 206018 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/12/19
|
ACTAVIS LLC |
| 201379 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/02/28
|
SAGENT PHARMS INC |
| 203655 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/12/08
|
DR REDDYS |
| 203393 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/12/22
|
FRESENIUS KABI USA |
| 204817 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/05/17
|
ALMAJECT |
| 209826 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/05/28
|
GLAND PHARMA LTD |
| 211463 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/09/13
|
ARTHUR GRP |
| 210947 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2020/02/18
|
INGENUS PHARMS LLC |
| 209197 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2020/05/08
|
BPI LABS |
| 212960 |
001 |
ANDA |
MELPHALAN HYDROCHLORIDE |
MELPHALAN HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/05/28
|
MEITHEAL |