You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 19, 2024

Details for New Drug Application (NDA): 075902


✉ Email this page to a colleague

« Back to Dashboard


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
Tradename:FLUVOXAMINE MALEATE
Applicant:Apotex
Ingredient:fluvoxamine maleate
Patents:0
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.