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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
Baxter
Medtronic
Federal Trade Commission
Chubb
Moodys
Colorcon
Fuji

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078406

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NDA 078406 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, 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 eighteen NDAs. It is available from fifty-one 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-five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 078406
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Aurobindo Pharma
Ingredient:paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078406
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 078406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078406 ANDA Aurolife Pharma LLC 13107-154 N 13107-154-01
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078406 ANDA Aurolife Pharma LLC 13107-154 N 13107-154-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 25, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 25, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Moodys
Citi
Cantor Fitzgerald
Boehringer Ingelheim
Fish and Richardson
Julphar
Federal Trade Commission
Deloitte

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