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Serving hundreds of leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Fish and Richardson
AstraZeneca
US Department of Justice
Farmers Insurance
Covington
Citi
Baxter

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091427

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NDA 091427 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 091427
Tradename:PAROXETINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 091427
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 091427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091427 ANDA Mylan Pharmaceuticals Inc. 0378-2005 N 0378-2005-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Apr 14, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Merck
QuintilesIMS
Chinese Patent Office
Moodys
UBS
Citi
Johnson and Johnson
Teva

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