Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075893
Company: TEVA
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
09/10/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/2009 SUPPL-11 Labeling

Label is not available on this site.

09/10/2009 SUPPL-10 Labeling

Label is not available on this site.

09/18/2008 SUPPL-9 Labeling

Label is not available on this site.

11/28/2007 SUPPL-7 Labeling

Label is not available on this site.

06/27/2007 SUPPL-6 Labeling

Label is not available on this site.

07/24/2006 SUPPL-5 Labeling

Label is not available on this site.

05/03/2005 SUPPL-4 Labeling

Label is not available on this site.

10/20/2004 SUPPL-3 Labeling

Label is not available on this site.

05/18/2004 SUPPL-2 Labeling

Label is not available on this site.

11/20/2003 SUPPL-1 Labeling

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 075897 ANI PHARMS INC
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription No AB 075893 TEVA
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 075897 ANI PHARMS INC
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription No AB 075893 TEVA
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 075897 ANI PHARMS INC
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription No AB 075902 APOTEX
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET;ORAL Prescription No AB 075893 TEVA
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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