.

BioPharmaceutical Business Intelligence

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

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Argus Health
Chinese Patent Office
Fish and Richardson
Healthtrust
McKesson
Julphar
Federal Trade Commission
Moodys
Mallinckrodt

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077584

« Back to Dashboard

NDA 077584 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Kremers Urban Pharms, Lupin Ltd, Mylan, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher-smith Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from fifty-three suppliers. Additional details are available on the PAROXETINE HYDROCHLORIDE profile page.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for 077584

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

Pharmacology for NDA: 077584

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077584

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5576 0615-5576-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-5576-05)
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5576 0615-5576-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-5576-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 7, 2007TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
QuintilesIMS
Cipla
UBS
Accenture
McKesson
Express Scripts
Chubb
Medtronic

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot