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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Cipla
Colorcon
UBS
US Department of Justice
Daiichi Sankyo
QuintilesIMS
Fish and Richardson
Boehringer Ingelheim

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078902

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NDA 078902 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 forty-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. Forty-five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 078902
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078902
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 078902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 N 0378-7001-10
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902 ANDA Mylan Pharmaceuticals Inc. 0378-7001 N 0378-7001-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 13, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Mallinckrodt
UBS
Argus Health
Teva
Daiichi Sankyo
Johnson and Johnson
Farmers Insurance

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