.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Accenture
Colorcon
Covington
Medtronic
Julphar
Baxter
Express Scripts
Cantor Fitzgerald
Farmers Insurance

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203854

« Back to Dashboard

NDA 203854 describes PAROXETINE, which is a drug marketed by Prinston Inc, 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, Zydus Pharms Usa, and Actavis Labs Fl Inc, and is included in twenty NDAs. It is available from eight suppliers. Additional details are available on the PAROXETINE profile page.

The generic ingredient in PAROXETINE is paroxetine mesylate. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

Summary for 203854

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

Pharmacology for NDA: 203854

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 203854

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)
PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7985 0615-7985-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Oct 31, 2014TE: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:

Boehringer Ingelheim
Mallinckrodt
Novartis
Covington
Chinese Patent Office
Express Scripts
McKesson
Healthtrust
Fuji
Baxter

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