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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 020031


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NDA 020031 describes PAXIL, which is a drug marketed by Apotex and is included in four NDAs. It is available from one supplier. 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-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020031
Tradename:PAXIL
Applicant:Apotex
Ingredient:paroxetine hydrochloride
Patents:0
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 60505-4517 60505-4517-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4517-3)
PAXIL paroxetine hydrochloride TABLET;ORAL 020031 NDA Apotex Corp 60505-4518 60505-4518-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4518-3)

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 PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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