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Last Updated: June 23, 2024

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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 28, 2008TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 28, 2008TE:RLD:Yes

Expired US Patents for NDA 022033

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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