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Generated: December 10, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020031

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NDA 020031 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 020031
Tradename:PAXIL
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020031
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 020031
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL paroxetine hydrochloride TABLET;ORAL 020031 NDA Apotex Corp 60505-3663 60505-3663-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3663-3)
PAXIL paroxetine hydrochloride TABLET;ORAL 020031 NDA Apotex Corp 60505-3664 60505-3664-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3664-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020031

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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