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 |
|---|
| 2022/09/23 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2022/05/20 |
SUPPL-34（补充） |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
| 2020/03/18 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2018/07/20 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2017/01/30 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2016/08/23 |
SUPPL-29（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2015/12/17 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2015/02/23 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2014/01/10 |
SUPPL-26（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2013/05/06 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2012/12/19 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2012/01/24 |
SUPPL-23（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2011/08/17 |
SUPPL-20（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2011/08/17 |
SUPPL-16（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2008/08/20 |
SUPPL-11（补充） |
Approval |
Efficacy |
PRIORITY
|
|
|
| 2008/02/22 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2007/01/26 |
SUPPL-5（补充） |
Approval |
Efficacy |
STANDARD
|
|
|
| 2005/06/29 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2004/05/19 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
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
|
MYLAN INSTITUTIONAL |
| 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 |
