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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 075902

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NDA 075902 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Bionpharma, Torrent, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs, and is included in eighteen 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. Twelve suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 075902
Ingredient:fluvoxamine maleate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075902 ANDA Apotex Corp 60505-0164 60505-0164-1 100 TABLET in 1 BOTTLE (60505-0164-1)
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075902 ANDA Apotex Corp 60505-0165 60505-0165-1 100 TABLET in 1 BOTTLE (60505-0165-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 7, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 7, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 7, 2001TE:ABRLD:No

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