药品注册申请号：208396
申请类型：ANDA (仿制药申请)
申请人：APOTEX
申请人全名：APOTEX INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No AB 2019/11/05 2019/11/05 Discontinued
002 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No AB 2019/11/05 Discontinued
003 ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE No No AB 2019/11/05 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/11/05 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
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RLDRSTE Code产品号批准日期申请人
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 Discontinued No No AB 2019/11/05 APOTEX
208488 001 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Discontinued No No AB 2019/11/05 NATCO PHARMA LTD
210300 001 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Discontinued 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
209267 001 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2024/05/24 HETERO LABS LTD V
203843 001 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2024/09/13 CHARTWELL RX
>>>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RLDRSTE Code产品号批准日期申请人
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 Discontinued No No AB 2019/11/05 APOTEX
208488 002 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Discontinued No No AB 2019/11/05 NATCO PHARMA LTD
210300 002 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Discontinued 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
209267 002 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2024/05/24 HETERO LABS LTD V
>>>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RLDRSTE Code产品号批准日期申请人
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 Discontinued No No AB 2019/11/05 APOTEX
208488 003 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Discontinued No No AB 2019/11/05 NATCO PHARMA LTD
210300 003 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Discontinued 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
209267 003 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2024/05/24 HETERO LABS LTD V
203843 002 ANDA ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2024/09/13 CHARTWELL RX
更多信息
药品NDC数据与药品包装、标签说明书
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