药品注册申请号：075245
申请类型：ANDA (仿制药申请)
申请人：IVAX SUB TEVA PHARMS
申请人全名：IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
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 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE No No AB1 2002/01/31 2002/01/31 Prescription
002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No AB1 2002/01/31 Prescription
003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE No No AB 2004/09/28 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
2016/01/10 SUPPL-35（补充） Approval Labeling STANDARD
2016/01/10 SUPPL-34（补充） Approval Labeling STANDARD
2016/01/10 SUPPL-33（补充） Approval Labeling STANDARD
2016/01/10 SUPPL-32（补充） Approval Labeling STANDARD
2016/01/10 SUPPL-31（补充） Approval Labeling
2010/05/13 SUPPL-29（补充） Approval Labeling
2009/10/26 SUPPL-28（补充） Approval Labeling
2009/06/15 SUPPL-22（补充） Approval Labeling
2009/03/30 SUPPL-27（补充） Approval Labeling
2008/08/21 SUPPL-26（补充） Approval Labeling
2008/02/11 SUPPL-19（补充） Approval Labeling
2007/10/24 SUPPL-18（补充） Approval Labeling
2007/10/24 SUPPL-17（补充） Approval Labeling
2005/12/14 SUPPL-16（补充） Approval Labeling
2005/12/14 SUPPL-15（补充） Approval Labeling
2004/10/19 SUPPL-11（补充） Approval Labeling
2004/09/28 SUPPL-3（补充） Approval Labeling
2002/08/16 SUPPL-1（补充） Approval Manufacturing (CMC)
2002/01/31 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
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:FLUOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 20MG BASE 治疗等效代码:AB1
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
018936 001 NDA PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription Yes No AB1 1987/12/29 ELI LILLY AND CO
075049 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/29 APNAR PHARMA LP
075452 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/29 TEVA
075465 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/29 MARKSANS PHARMA
076001 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/29 TEVA PHARMS USA
075464 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/30 LANDELA PHARM
075245 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2002/01/31 IVAX SUB TEVA PHARMS
078619 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2008/01/31 AUROBINDO PHARMA
090223 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2009/03/19 ALEMBIC PHARMS LTD
201336 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2012/10/01 HERITAGE PHARMS
204597 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2015/03/16 SCIEGEN PHARMS INC
206993 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2019/05/23 CADILA PHARMS LTD
216232 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB1 2022/03/29 MICRO LABS
活性成分:FLUOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 10MG BASE 治疗等效代码:AB1
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
018936 006 NDA PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription Yes No AB1 1992/12/23 ELI LILLY AND CO
075049 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2001/08/02 APNAR PHARMA LP
075452 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2002/01/29 TEVA
075465 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2002/01/29 MARKSANS PHARMA
076001 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2002/01/29 TEVA PHARMS USA
075464 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2002/01/30 LANDELA PHARM
075245 002 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2002/01/31 IVAX SUB TEVA PHARMS
078619 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2008/01/31 AUROBINDO PHARMA
090223 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2009/03/19 ALEMBIC PHARMS LTD
201336 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2012/10/01 HERITAGE PHARMS
204597 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2015/03/16 SCIEGEN PHARMS INC
206993 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2019/05/23 CADILA PHARMS LTD
216232 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB1 2022/03/29 MICRO LABS
活性成分:FLUOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 40MG 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
018936 003 NDA PROZAC FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription Yes Yes AB 1999/06/15 ELI LILLY AND CO
075465 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2001/08/02 MARKSANS PHARMA
075049 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2002/01/29 APNAR PHARMA LP
075452 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2002/01/29 TEVA
075245 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2004/09/28 IVAX SUB TEVA PHARMS
076990 001 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Discontinued No No AB 2004/12/13 SUN PHARM INDS LTD
078619 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2008/01/31 AUROBINDO PHARMA
090223 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2009/03/19 ALEMBIC PHARMS LTD
201336 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/10/01 HERITAGE PHARMS
204597 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2015/03/16 SCIEGEN PHARMS INC
206993 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2019/05/23 CADILA PHARMS LTD
216232 003 ANDA FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2022/03/29 MICRO LABS
更多信息
药品NDC数据与药品包装、标签说明书
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