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Serving leading biopharmaceutical companies globally:

Chinese Patent Office

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021519

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NDA 021519 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. 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. Fifteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 021519
Applicant:Ani Pharms
Ingredient:fluvoxamine maleate
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC Aidarex Pharmaceuticals LLC 33261-683 33261-683-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (33261-683-30)
LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA REMEDYREPACK INC. 49349-991 49349-991-02 30 TABLET in 1 BLISTER PACK (49349-991-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 20, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 20, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 20, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance

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