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Federal Trade Commission
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Generated: February 19, 2018

DrugPatentWatch Database Preview

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. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. 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. Fifteen 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:1
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033 NDA Jazz Pharmaceuticals, Inc. 68727-600 N 68727-600-01
LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033 NDA Jazz Pharmaceuticals, Inc. 68727-601 N 68727-601-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 28, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Feb 28, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI

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Cipla
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Fish and Richardson

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