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Details for New Drug Application (NDA): 075950

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NDA 075950 describes FLUVOXAMINE MALEATE, which is a drug marketed by Nostrum Labs Inc, Actavis Elizabeth, Apotex, Sun Pharm Inds, Torrent Pharms Ltd, Mylan, Anchen Pharms, Upsher-smith Labs, Teva, Watson Labs, Ani Pharms Inc, and Synthon Pharms, and is included in sixteen NDAs. It is available from twelve 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. Sixteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for NDA: 075950

Tradename:
FLUVOXAMINE MALEATE
Applicant:
Mylan
Ingredient:
fluvoxamine maleate
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Oct 15, 2001TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Oct 15, 2001TE:RLD:No


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