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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020710

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NDA 020710 describes PAXIL, which is a drug marketed by Apotex Technologies and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the PAXIL profile page.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020710
Tradename:PAXIL
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020710
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 020710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710 NDA Apotex Corp 60505-0402 60505-0402-5 250 mL in 1 BOTTLE (60505-0402-5)
Paragraph IV (Patent) Challenges for 020710
Tradename Dosage Ingredient NDA Submissiondate
PAXIL SUSPENSION;ORAL paroxetine hydrochloride 020710 2005-02-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Jun 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020710

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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