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Generated: November 15, 2018

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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 three 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. Fifty-three 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 Rebel Distributors Corp 21695-159 21695-159-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-159-15)
PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 NDA Rebel Distributors Corp 21695-159 21695-159-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-159-30)

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

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Boehringer Ingelheim
McKesson
Express Scripts
Harvard Business School
US Department of Justice
QuintilesIMS
Medtronic

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