Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075894

✉ Email this page to a colleague

« Back to Dashboard

NDA 075894 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 075894

Tradename:	FLUVOXAMINE MALEATE
Applicant:	Heritage Pharma
Ingredient:	fluvoxamine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075894

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 18, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 18, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 18, 2001	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.