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Chubb
Harvard Business School
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US Department of Justice
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Farmers Insurance
Medtronic
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075888

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NDA 075888 describes FLUVOXAMINE MALEATE, which is a drug marketed by Actavis Elizabeth, Anchen Pharms, Torrent Pharms Ltd, Ani Pharms Inc, Apotex, Eci Pharms Llc, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, Upsher-smith Labs, and Watson Labs, and is included in sixteen NDAs. It is available from ten 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. Fourteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

Summary for 075888

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 075888

Mechanism of ActionSerotonin Uptake Inhibitors

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 Eon Labs, Inc. 0185-0017 0185-0017-01 100 TABLET, FILM COATED in 1 BOTTLE (0185-0017-01)
FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888 ANDA Eon Labs, Inc. 0185-0027 0185-0027-05 500 TABLET, FILM COATED in 1 BOTTLE (0185-0027-05)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Queensland Health
Deloitte
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Citi
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Cerilliant
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Fish and Richardson
US Army
Harvard Business School

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