Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075872
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB 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
01/29/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75872TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/18/2014 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/16/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/28/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/28/2014 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/25/2011 SUPPL-13 Labeling

Label is not available on this site.

03/23/2009 SUPPL-11 Labeling

Label is not available on this site.

12/03/2008 SUPPL-10 Labeling

Label is not available on this site.

02/14/2008 SUPPL-8 Labeling

Label is not available on this site.

02/14/2008 SUPPL-7 Labeling

Label is not available on this site.

04/11/2007 SUPPL-6 Labeling

Label is not available on this site.

08/17/2006 SUPPL-5 Labeling

Label is not available on this site.

09/13/2005 SUPPL-4 Labeling

Label is not available on this site.

09/13/2004 SUPPL-3 Labeling

Label is not available on this site.

11/24/2003 SUPPL-1 Labeling

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

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

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 AB 208698 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 076006 DR REDDYS LABS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 211653 LUPIN LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 075755 MYLAN
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 203836 PAR FORM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 210935 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 075872 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 211696 UPSHER SMITH LABS

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

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 AB 208698 ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 076006 DR REDDYS LABS LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 211653 LUPIN LTD
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 075755 MYLAN
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 203836 PAR FORM
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 210935 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 075872 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 211696 UPSHER SMITH LABS

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