Details for New Drug Application (NDA): 011459

NDA 011459 describes VISTARIL, which is a drug marketed by Pfizer and is included in three NDAs. It is available from two suppliers. Additional details are available on the VISTARIL profile page.

The generic ingredient in VISTARIL is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 011459

Tradename:	VISTARIL
Applicant:	Pfizer
Ingredient:	hydroxyzine pamoate
Patents:	0

Pharmacology for NDA: 011459

Mechanism of Action

Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 011459

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VISTARIL	hydroxyzine pamoate	CAPSULE;ORAL	011459	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5410	0069-5410-66	100 CAPSULE in 1 BOTTLE (0069-5410-66)
VISTARIL	hydroxyzine pamoate	CAPSULE;ORAL	011459	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-5420	59762-5420-1	100 CAPSULE in 1 BOTTLE (59762-5420-1)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG HYDROCHLORIDE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG HYDROCHLORIDE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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