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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021519


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NDA 021519 describes LUVOX, which is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms, and is included in three NDAs. It is available from four suppliers. Additional details are available on the LUVOX profile page.

The generic ingredient in LUVOX is fluvoxamine maleate. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 021519
Tradename:LUVOX
Applicant:Ani Pharms
Ingredient:fluvoxamine maleate
Patents:0
Medical Subject Heading (MeSH) Categories for 021519
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Serotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-5988 50090-5988-0 90 TABLET, COATED in 1 BOTTLE (50090-5988-0)
LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-158 62559-158-01 100 TABLET, COATED in 1 BOTTLE (62559-158-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 20, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 20, 2007TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 20, 2007TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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