Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075899

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NDA 075899 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Annora Pharma, Appco, Bionpharma, Micro Labs, Ph Health, Torrent, Zydus Pharms, 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-three NDAs. It is available from sixteen suppliers. Additional details are available on the FLUVOXAMINE MALEATE profile page.

The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for 075899

Tradename:	FLUVOXAMINE MALEATE
Applicant:	Synthon Pharms
Ingredient:	fluvoxamine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075899

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:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 17, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 17, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 17, 2001	TE:		RLD:	No

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