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Generated: November 14, 2018

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 are two patents 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. Fifty-three 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)

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

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Merck
Covington
US Department of Justice
Argus Health
Citi
Baxter
Queensland Health
Cipla

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