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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076125

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NDA 076125 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Annora Pharma, 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 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 076125

Tradename:	FLUVOXAMINE MALEATE
Applicant:	Sun Pharm Industries
Ingredient:	fluvoxamine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076125

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:	Apr 29, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 29, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 29, 2002	TE:		RLD:	No

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