Details for New Drug Application (NDA): 020031

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 Action

Serotonin 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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Dec 29, 1992	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 29, 1992	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Dec 29, 1992	TE:	AB	RLD:	Yes

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