Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075888
Company: UPSHER SMITH LABS
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75888ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2015 SUPPL-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/29/2015 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/09/2013 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/11/2009 SUPPL-24 Labeling

Label is not available on this site.

09/14/2007 SUPPL-23 Labeling

Label is not available on this site.

06/27/2007 SUPPL-21 Labeling

Label is not available on this site.

07/24/2006 SUPPL-19 Labeling

Label is not available on this site.

05/03/2005 SUPPL-16 Labeling

Label is not available on this site.

04/20/2005 SUPPL-14 Labeling

Label is not available on this site.

09/30/2004 SUPPL-12 Labeling

Label is not available on this site.

06/10/2004 SUPPL-11 Labeling

Label is not available on this site.

01/22/2003 SUPPL-4 Labeling

Label is not available on this site.

03/15/2002 SUPPL-1 Manufacturing (CMC)-Facility

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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