Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075506
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription AA 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
08/02/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75506ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75506_Prozac.pdf
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.

12/27/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/31/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/31/2012 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/06/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/09/2009 SUPPL-14 Labeling

Label is not available on this site.

10/22/2008 SUPPL-13 Labeling

Label is not available on this site.

02/14/2008 SUPPL-11 Labeling

Label is not available on this site.

02/14/2008 SUPPL-10 Labeling

Label is not available on this site.

03/28/2007 SUPPL-8 Labeling

Label is not available on this site.

08/17/2006 SUPPL-7 Labeling

Label is not available on this site.

01/31/2006 SUPPL-6 Labeling

Label is not available on this site.

01/31/2006 SUPPL-5 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-2 Labeling

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 077849 LANNETT CO INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 076015 PHARM ASSOC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075920 SPECGX LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075506 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075514 WOCKHARDT BIO AG

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