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Last Updated: February 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076125


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NDA 076125 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 six 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. Ten suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 076125
Tradename:FLUVOXAMINE MALEATE
Applicant:Sun Pharm Industries
Ingredient:fluvoxamine maleate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Apr 29, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Apr 29, 2002TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Apr 29, 2002TE:RLD:No

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