美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TRAL"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
SERTRALINE HYDROCHLORIDE 078626 002 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 2008/01/31 2008/01/31 MYLAN PHARMS INC Discontinued
SERTRALINE HYDROCHLORIDE 078626 003 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No 2008/01/31 2008/01/31 MYLAN PHARMS INC Discontinued
SERTRALINE HYDROCHLORIDE 078861 001 ANDA SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML No No 2008/10/31 2008/10/31 AUROBINDO PHARMA Prescription
SERTRALINE HYDROCHLORIDE 078677 001 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 2009/03/04 2009/03/04 REYOUNG Prescription
SERTRALINE HYDROCHLORIDE 078677 002 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 2009/03/04 2009/03/04 REYOUNG Prescription
SERTRALINE HYDROCHLORIDE 078677 003 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No 2009/03/04 2009/03/04 REYOUNG Prescription
SERTRALINE HYDROCHLORIDE 077864 001 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 2009/08/10 2009/08/10 HIKMA PHARMS Discontinued
SERTRALINE HYDROCHLORIDE 077864 002 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 2009/08/10 2009/08/10 HIKMA PHARMS Discontinued
SERTRALINE HYDROCHLORIDE 077864 003 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No 2009/08/10 2009/08/10 HIKMA PHARMS Discontinued
SERTRALINE HYDROCHLORIDE 078175 001 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 2010/07/21 2010/07/21 OXFORD PHARMS Prescription
SERTRALINE HYDROCHLORIDE 078175 002 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 2010/07/21 2010/07/21 OXFORD PHARMS Prescription
SERTRALINE HYDROCHLORIDE 078175 003 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No 2010/07/21 2010/07/21 OXFORD PHARMS Prescription
ABSTRAL 022510 001 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
ABSTRAL 022510 002 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
ABSTRAL 022510 003 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
ABSTRAL 022510 004 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
ABSTRAL 022510 005 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
ABSTRAL 022510 006 NDA FENTANYL CITRATE TABLET;SUBLINGUAL EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/01/07 2011/01/07 SENTYNL THERAPS INC Discontinued
SERTRALINE HYDROCHLORIDE 202825 001 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 2014/11/07 2014/11/07 ACCORD HLTHCARE Prescription
SERTRALINE HYDROCHLORIDE 202825 002 ANDA SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 2014/11/07 2014/11/07 ACCORD HLTHCARE Prescription
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