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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020936

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NDA 020936 describes PAXIL CR, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. Additional details are available on the PAXIL CR profile page.

The generic ingredient in PAXIL CR 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 020936

Tradename:	PAXIL CR
Applicant:	Apotex
Ingredient:	paroxetine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020936

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020936

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA	Apotex Corp	60505-1316	60505-1316-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1316-3)
PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA	Apotex Corp	60505-1317	60505-1317-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Feb 16, 1999	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Feb 16, 1999	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	Dec 6, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020936

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	⤷ Try a Trial	⤷ Try a Trial
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	⤷ Try a Trial	⤷ Try a Trial
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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