Last Updated: May 11, 2026

Details for New Drug Application (NDA): 011795

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NDA 011795 describes VISTARIL, which is a drug marketed by Pfizer and is included in three NDAs. 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. Fifty-one suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 011795

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 25MG HYDROCHLORIDE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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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