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 |
2016/10/18 |
SUPPL-25(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2016/09/28 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/01 |
SUPPL-27(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2016/05/20 |
SUPPL-23(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2016/03/15 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/07/06 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/04/27 |
SUPPL-21(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2014/04/14 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/14 |
SUPPL-18(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2012/04/17 |
SUPPL-17(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/16 |
SUPPL-16(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2010/04/16 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/27 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/09/19 |
SUPPL-11(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2008/09/12 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/09/12 |
SUPPL-8(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2007/04/27 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/11/02 |
SUPPL-3(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2004/11/18 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:ERLOTINIB HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 25MG BASE 治疗等效代码:AB
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 |
021743 |
001 |
NDA |
TARCEVA |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Discontinued |
Yes |
No |
AB |
2004/11/18
|
OSI PHARMS |
091002 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2014/06/11
|
RISING |
208396 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
APOTEX |
208488 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
NATCO PHARMA LTD |
210300 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SUN PHARM |
211960 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SHILPA |
213065 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/04/16
|
ZYDUS PHARMS |
091059 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/11/09
|
TEVA PHARMS USA INC |
214366 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/05/10
|
MSN |
214719 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/07/08
|
ALEMBIC |
216342 |
001 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 25MG BASE |
Discontinued |
No |
No |
AB |
2022/06/22
|
EUGIA PHARMA |
活性成分:ERLOTINIB HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 100MG BASE 治疗等效代码:AB
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 |
021743 |
002 |
NDA |
TARCEVA |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
Yes |
No |
AB |
2004/11/18
|
OSI PHARMS |
091002 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2014/06/11
|
RISING |
091059 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2015/08/28
|
TEVA PHARMS USA INC |
208396 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
APOTEX |
208488 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
NATCO PHARMA LTD |
210300 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SUN PHARM |
211960 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SHILPA |
213065 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/04/16
|
ZYDUS PHARMS |
214366 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2021/05/10
|
MSN |
214719 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2021/07/08
|
ALEMBIC |
216342 |
002 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2022/06/22
|
EUGIA PHARMA |
活性成分:ERLOTINIB HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 150MG BASE 治疗等效代码:AB
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 |
021743 |
003 |
NDA |
TARCEVA |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Discontinued |
Yes |
No |
AB |
2004/11/18
|
OSI PHARMS |
091002 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2014/06/11
|
RISING |
091059 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2015/08/28
|
TEVA PHARMS USA INC |
208396 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
APOTEX |
208488 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
NATCO PHARMA LTD |
210300 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SUN PHARM |
211960 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2019/11/05
|
SHILPA |
213065 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
Yes |
AB |
2020/04/16
|
ZYDUS PHARMS |
214366 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2021/05/10
|
MSN |
214719 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2021/07/08
|
ALEMBIC |
216342 |
003 |
ANDA |
ERLOTINIB HYDROCHLORIDE |
ERLOTINIB HYDROCHLORIDE |
TABLET;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
2022/06/22
|
EUGIA PHARMA |