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Details for New Drug Application (NDA): 075902

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NDA 075902 describes FLUVOXAMINE MALEATE, which is a drug marketed by Nostrum Labs Inc, Actavis Elizabeth, Apotex, Sun Pharm Inds, Torrent Pharms Ltd, Mylan, Anchen Pharms, Sandoz, Teva, Watson Labs, Ani Pharms Inc, and Synthon Pharms, and is included in sixteen NDAs. It is available from thirteen 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: 075902

fluvoxamine maleate
Therapeutic Class:Antidepressants

Pharmacology for NDA: 075902

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 075902

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluvoxamine maleate
TABLET;ORAL 075902 ANDA Golden State Medical Supply, Inc. 60429-758 60429-758-01 100 TABLET in 1 BOTTLE (60429-758-01)
fluvoxamine maleate
TABLET;ORAL 075902 ANDA Golden State Medical Supply, Inc. 60429-759 60429-759-01 100 TABLET in 1 BOTTLE (60429-759-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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