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 |
2024/06/28 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
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 |
212580 |
001 |
ANDA |
AZACITIDINE |
AZACITIDINE |
POWDER;INTRAVENOUS, SUBCUTANEOUS |
100MG/VIAL |
Prescription |
No |
No |
AP |
2024/05/16
|
MSN LABS PVT LTD |