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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020710

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NDA 020710 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 020710

Tradename:	PAXIL
Applicant:	Apotex
Ingredient:	paroxetine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 10MG BASE/5ML
Approval Date:	Jun 25, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020710

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,172,233*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	5,900,423*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,133,289*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	4,721,723*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,080,759*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,063,927*PED	⤷ Get Started Free
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	5,872,132*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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