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Drugs@FDA: FDA-Approved Drugs

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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 Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Discontinued None 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
08/18/2023 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/08/2023 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2021 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
08/27/2021 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/27/2021 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
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-Medication Guide, Labeling-Package Insert

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.
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