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 six suppliers. There is one patent protecting this drug and two Paragraph IV challenges. 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. Sixteen 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DISCN	Dosage:	TABLET;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	➤ Sign Up	➤ Sign Up
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994	➤ Sign Up	➤ Sign Up
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994	➤ Sign Up	➤ Sign Up
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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