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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020885


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NDA 020885 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-two suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020885
Tradename:PAXIL
Applicant:Apotex
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 9, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 9, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 9, 1998TE:RLD:Yes

Expired US Patents for NDA 020885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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