Last Updated: August 2, 2026

Details for New Drug Application (NDA): 220328

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NDA 220328 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Annora Pharma, Appco, Bionpharma, Ph Health, Torrent, Aiping Pharm Inc, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Quagen, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in twenty-one NDAs. It is available from thirteen suppliers. Additional details are available on the FLUVOXAMINE MALEATE profile page.

The generic ingredient in FLUVOXAMINE MALEATE 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 220328

Tradename:	FLUVOXAMINE MALEATE
Applicant:	Appco
Ingredient:	fluvoxamine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 220328

Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Apr 30, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Apr 30, 2026	TE:	AB	RLD:	No

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