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Generated: November 16, 2018

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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 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. Fifty-six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 011459
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 Pfizer Laboratories Div Pfizer Inc 0069-5420 0069-5420-66 100 CAPSULE in 1 BOTTLE (0069-5420-66)

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100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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