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 |
|---|
| 2024/05/16 |
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:AZACITIDINE 剂型/给药途径:POWDER;INTRAVENOUS, SUBCUTANEOUS 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 |
|---|
| 050794 |
001 |
NDA |
VIDAZA |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
Yes |
Yes |
AP |
2004/05/19
|
BRISTOL-MYERS |
| 201537 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2013/09/16
|
DR REDDYS |
| 204949 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Discontinued |
No |
No |
AP |
2016/04/28
|
NORVIUM BIOSCIENCE |
| 208216 |
001 |
NDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2016/04/29
|
ACTAVIS LLC |
| 207518 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2016/09/29
|
SHILPA MEDICARE |
| 207234 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2017/06/23
|
NATCO PHARMA LTD |
| 209540 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2018/05/04
|
CIPLA |
| 207475 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2018/07/02
|
ACCORD HLTHCARE |
| 209337 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2020/06/08
|
EUROHLTH INTL SARL |
| 212128 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2020/11/02
|
MEITHEAL |
| 211549 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2022/02/03
|
AMNEAL |
| 215066 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/30
|
EUGIA PHARMA |
| 215905 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/28
|
JIANGSU HANSOH PHARM |
| 212580 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2024/05/16
|
MSN LABS PVT LTD |
| 215765 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2024/10/15
|
HETERO LABS LTD VI |