Details for New Drug Application (NDA): 022033

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NDA 022033 describes LUVOX CR, which is a drug marketed by Jazz Pharms and is included in one NDA. Additional details are available on the LUVOX CR profile page.

The generic ingredient in LUVOX CR is fluvoxamine maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for 022033

Tradename:	LUVOX CR
Applicant:	Jazz Pharms
Ingredient:	fluvoxamine maleate
Patents:	0

Medical Subject Heading (MeSH) Categories for 022033

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:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 022033

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-001	Feb 28, 2008	⤷ Sign Up	⤷ Sign Up
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-002	Feb 28, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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