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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020936


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NDA 020936 describes PAXIL CR, which is a drug marketed by Apotex Technologies and is included in one NDA. It is available from two suppliers. Additional details are available on the PAXIL CR profile page.

The generic ingredient in PAXIL CR is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020936
Tradename:PAXIL CR
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020936
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 020936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 NDA Apotex Corp 60505-1316 60505-1316-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1316-3)
PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 NDA Apotex Corp 60505-1317 60505-1317-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)
Paragraph IV (Patent) Challenges for 020936
Tradename Dosage Ingredient NDA Submissiondate
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2009-05-19
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2005-09-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 12.5MG BASE
Approval Date:Feb 16, 1999TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Feb 16, 1999TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 37.5MG BASE
Approval Date:Dec 6, 2000TE:ABRLD:Yes

Expired US Patents for NDA 020936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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