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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 011459


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NDA 011459 describes VISTARIL, which is a drug marketed by Pfizer and is included in three NDAs. It is available from one supplier. 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-nine 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 ActionHistamine 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)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG HYDROCHLORIDE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG HYDROCHLORIDE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 006

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100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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