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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075902
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription AB No No
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription AB No No
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription AB 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
05/07/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75902ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/17/2020 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/17/2020 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/28/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/28/2015 SUPPL-18 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/19/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/03/2009 SUPPL-16 Labeling

Label is not available on this site.

06/27/2007 SUPPL-13 Labeling

Label is not available on this site.

07/24/2006 SUPPL-12 Labeling

Label is not available on this site.

07/24/2006 SUPPL-11 Labeling

Label is not available on this site.

07/08/2005 SUPPL-10 Labeling

Label is not available on this site.

10/20/2004 SUPPL-6 Labeling

Label is not available on this site.

05/14/2004 SUPPL-5 Labeling

Label is not available on this site.

02/20/2004 SUPPL-4 Labeling

Label is not available on this site.

01/14/2003 SUPPL-2 Labeling

Label is not available on this site.

11/27/2002 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

FLUVOXAMINE MALEATE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription No AB 075888 UPSHER SMITH LABS
LUVOX FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription No AB 021519 ANI PHARMS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription No AB 075888 UPSHER SMITH LABS
LUVOX FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription No AB 021519 ANI PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription No AB 075888 UPSHER SMITH LABS
LUVOX FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription No AB 021519 ANI PHARMS
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