Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021519
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUVOX FLUVOXAMINE MALEATE 25MG TABLET;ORAL Prescription AB No No
LUVOX FLUVOXAMINE MALEATE 50MG TABLET;ORAL Prescription AB No No
LUVOX 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
12/20/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021519s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519_luvox_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2019 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021519Orig1s012ltr.pdf
01/04/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021519Orig1s009ltr.pdf
07/18/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021519Orig1s008ltr.pdf
10/23/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/10/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/28/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/24/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021519Orig1s003ltr.pdf
03/16/2011 SUPPL-2 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021519s002ltr.pdf
02/24/2009 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf
01/04/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf
07/18/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf
11/30/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf
03/16/2011 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf
02/24/2009 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf
12/20/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf

LUVOX

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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