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Last Updated: May 21, 2022

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-two 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020710

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020710

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710	NDA	Apotex Corp	60505-0402	60505-0402-5	250 mL in 1 BOTTLE (60505-0402-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	EQ 10MG BASE/5ML
Approval Date:	Jun 25, 1997	TE:	AB	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	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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