Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075207
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;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
01/30/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75207ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/15/2011 SUPPL-23 Labeling

Label is not available on this site.

12/10/2009 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

07/09/2009 SUPPL-17 Labeling

Label is not available on this site.

02/11/2008 SUPPL-14 Labeling

Label is not available on this site.

02/11/2008 SUPPL-13 Labeling

Label is not available on this site.

02/22/2007 SUPPL-12 Labeling

Label is not available on this site.

02/22/2007 SUPPL-11 Labeling

Label is not available on this site.

05/25/2007 SUPPL-10 Labeling

Label is not available on this site.

05/25/2007 SUPPL-9 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/17/2006 SUPPL-6 Labeling

Label is not available on this site.

01/31/2006 SUPPL-5 Labeling

Label is not available on this site.

04/22/2005 SUPPL-4 Labeling

Label is not available on this site.

04/22/2005 SUPPL-3 Labeling

Label is not available on this site.

09/13/2004 SUPPL-2 Labeling

Label is not available on this site.

11/14/2003 SUPPL-1 Labeling

Label is not available on this site.

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