Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206937
Company: TORRENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB1 No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/21/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB1 206937 TORRENT
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB1 021860 APIL
SELFEMRA FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB1 200151 TEVA PHARMS USA

TABLET;ORAL; EQ 20MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB1 206937 TORRENT
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB1 021860 APIL
SELFEMRA FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB1 200151 TEVA PHARMS USA

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