Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075755
Company: MYLAN
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/02/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075755_fluoxetine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/14/2016 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf
11/14/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

02/13/2009 SUPPL-17 Labeling

Label is not available on this site.

04/06/2009 SUPPL-16 Labeling

Label is not available on this site.

10/08/2008 SUPPL-15 Labeling

Label is not available on this site.

04/17/2008 SUPPL-14 Labeling

Label is not available on this site.

08/03/2007 SUPPL-13 Labeling

Label is not available on this site.

08/03/2007 SUPPL-12 Labeling

Label is not available on this site.

05/11/2005 SUPPL-10 Labeling

Label is not available on this site.

05/11/2005 SUPPL-8 Labeling

Label is not available on this site.

05/03/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/17/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf
08/02/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf

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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