药品注册申请号:078297
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA
申请人全名:AUROBINDO PHARMA LTD
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 TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE No Yes AB 2007/07/02 2007/07/02 Prescription
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
2019/12/03 SUPPL-20(补充) Approval Labeling STANDARD
2019/12/03 SUPPL-18(补充) Approval Labeling STANDARD
2019/12/03 SUPPL-17(补充) Approval Labeling STANDARD
2019/12/03 SUPPL-16(补充) Approval Labeling STANDARD
2015/08/25 SUPPL-13(补充) Approval Labeling STANDARD
2015/08/25 SUPPL-12(补充) Approval Labeling STANDARD
2013/02/05 SUPPL-10(补充) Approval Labeling STANDARD
2011/09/21 SUPPL-8(补充) Approval Labeling
2008/07/14 SUPPL-2(补充) Approval Labeling
2008/04/04 SUPPL-1(补充) Approval Manufacturing (CMC)
2007/07/02 ORIG-1(原始申请) Approval
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
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
与本品治疗等效的药品
活性成分:TERBINAFINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 250MG 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
076377 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Discontinued No No AB 2007/07/02 HERITAGE PHARMA AVET
076390 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 DR REDDYS LABS INC
077137 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Discontinued No No AB 2007/07/02 CIPLA
077533 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 INVAGEN PHARMS
077919 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 EMED MEDCL
078157 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 GLENMARK PHARMS LTD
078163 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 ORBION PHARMS
078199 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2007/07/02 CHARTWELL
078297 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No Yes AB 2007/07/02 AUROBINDO PHARMA
077714 001 ANDA TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Prescription No No AB 2010/06/04 BRECKENRIDGE PHARM
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