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Last Updated: October 27, 2021

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Details for New Drug Application (NDA): 020243

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NDA 020243 describes LUVOX, which is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms, and is included in three NDAs. It is available from five 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. Ten suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for 020243

Tradename:	LUVOX
Applicant:	Solvay
Ingredient:	fluvoxamine maleate
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020243

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DISCN	Dosage:	TABLET;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Dec 5, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Dec 5, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Dec 5, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020243

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-001	Dec 5, 1994	⤷ Try it Free	⤷ Try it Free
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994	⤷ Try it Free	⤷ Try it Free
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994	⤷ Try it Free	⤷ Try it Free
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. 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.