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Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075893

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NDA 075893 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Torrent, Ani Pharms Inc, Apotex, Eci Pharms Llc, Heritage Pharma, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the FLUVOXAMINE MALEATE profile page.

The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 075893
Tradename:FLUVOXAMINE MALEATE
Applicant:Teva
Ingredient:fluvoxamine maleate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075893
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075893 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7569 0615-7569-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7569-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 10, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 10, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 10, 2002TE:ABRLD:No

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