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-four 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

Profile for product number 001

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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 002

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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 003

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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 30MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Expired US Patents for NDA 020885

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998	6,080,759*PED	⤷ Subscribe
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998	4,721,723*PED	⤷ Subscribe
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998	6,133,289*PED	⤷ Subscribe
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998	6,063,927*PED	⤷ Subscribe
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998	6,172,233*PED	⤷ Subscribe
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998	5,900,423*PED	⤷ Subscribe
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