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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075888


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NDA 075888 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Bionpharma, Endo Operations, Torrent, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Norvium Bioscience, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in nineteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 075888
Tradename:FLUVOXAMINE MALEATE
Applicant:Upsher Smith Labs
Ingredient:fluvoxamine maleate
Patents:0
Suppliers and Packaging for NDA: 075888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888 ANDA Upsher-Smith Laboratories, LLC 0832-1670 0832-1670-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-1670-11)
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888 ANDA Upsher-Smith Laboratories, LLC 0832-1671 0832-1671-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 29, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 29, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 29, 2000TE:ABRLD:No

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