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Serving leading biopharmaceutical companies globally:

Teva
Argus Health
Mallinckrodt
Medtronic
Novartis
Cantor Fitzgerald
US Department of Justice
QuintilesIMS
Accenture
Queensland Health

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075356

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NDA 075356 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-four 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-seven suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 075356
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Apotex
Ingredient:paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075356
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 075356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075356 ANDA Major Pharmaceuticals 0904-5676 0904-5676-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5676-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075356 ANDA Major Pharmaceuticals 0904-5677 0904-5677-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5677-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 30, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 30, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 30, 2003TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Merck
Cipla
Federal Trade Commission
Julphar
Fuji
Deloitte
US Army
McKesson

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