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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021519
Company: ANI PHARMS

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 021519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUVOX	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	AB	Yes	No
LUVOX	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	AB	Yes	No
LUVOX	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021519

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
08/18/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021519Orig1s026ltr.pdf
09/20/2022	SUPPL-21	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021519Orig1s021Correctedltr.pdf
09/20/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/21519Orig1s018ltr.pdf
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

Labels for NDA 021519

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf
09/20/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf
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

Therapeutic Equivalents for NDA 021519

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	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	Yes	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	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	Yes	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	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	Yes	AB	021519	ANI PHARMS

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