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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075658
Company: SPECGX LLC

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

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/2000/75658ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2020 SUPPL-33 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/20/2020 SUPPL-32 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/20/2020 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/20/2020 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/12/2017 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/28/2009 SUPPL-28 Labeling

Label is not available on this site.
09/25/2008 SUPPL-27 Labeling

Label is not available on this site.
03/03/2008 SUPPL-26 Labeling

Label is not available on this site.
06/29/2007 SUPPL-25 Labeling

Label is not available on this site.
06/29/2007 SUPPL-23 Labeling

Label is not available on this site.
09/27/2006 SUPPL-22 Labeling

Label is not available on this site.
02/28/2006 SUPPL-21 Labeling

Label is not available on this site.
02/28/2006 SUPPL-20 Labeling

Label is not available on this site.
10/21/2005 SUPPL-19 Labeling

Label is not available on this site.
12/06/2004 SUPPL-16 Labeling

Label is not available on this site.
12/06/2004 SUPPL-13 Labeling

Label is not available on this site.
08/20/2004 SUPPL-11 Labeling

Label is not available on this site.
11/13/2003 SUPPL-7 Labeling

Label is not available on this site.
11/24/2002 SUPPL-6 Labeling

Label is not available on this site.
11/05/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/05/2002 SUPPL-3 Labeling

Label is not available on this site.
11/05/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.
11/05/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.
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