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 |
|---|
| 2021/03/17 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/17 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/16 |
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:DECITABINE 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/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 |
|---|
| 203131 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2013/07/11
|
DR REDDYS |
| 202969 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2014/08/28
|
SANDOZ |
| 203475 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
Yes |
AP |
2017/02/27
|
ACCORD HLTHCARE |
| 204607 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2017/05/31
|
PHARMASCIENCE INC |
| 206033 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2017/09/22
|
CHEMI SPA |
| 207100 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2018/03/16
|
SAGENT PHARMS INC |
| 210756 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2018/11/09
|
LUPIN LTD |
| 209056 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2019/04/09
|
WOCKHARDT BIO AG |
| 212265 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2019/08/28
|
MSN |
| 210984 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2019/09/16
|
NOVAST LABS |
| 205539 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2020/11/23
|
GLAND |
| 212117 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2020/12/07
|
NIVAGEN PHARMS INC |
| 212826 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/04/12
|
QILU PHARM HAINAN |
| 212959 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/07/02
|
MEITHEAL |
| 214569 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/09/20
|
EUGIA PHARMA |
| 214486 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2021/11/19
|
ZYDUS PHARMS |
| 213472 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2022/04/15
|
JIANGSU HANSOH PHARM |
| 215355 |
001 |
ANDA |
DECITABINE |
DECITABINE |
INJECTABLE;INTRAVENOUS |
50MG/VIAL |
Prescription |
No |
No |
AP |
2024/05/10
|
HETERO LABS LTD VI |