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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

UBS
Cerilliant
Daiichi Sankyo
Teva
US Army
Express Scripts
AstraZeneca
Federal Trade Commission
Chubb
Boehringer Ingelheim

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091476

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NDA 091476 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 091476

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

Pharmacology for NDA: 091476

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 091476

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUVOXAMINE MALEATE fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 091476 ANDA Par Pharmaceutical, Inc. 10370-175 10370-175-11 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-11)
FLUVOXAMINE MALEATE fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 091476 ANDA Par Pharmaceutical, Inc. 10370-175 10370-175-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Mar 13, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Mar 13, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
Fish and Richardson
Baxter
QuintilesIMS
Moodys
AstraZeneca
Accenture
US Army
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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