🇺🇸 Hydroxyzine HCL in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Hydroxyzine HCL on 12 April 1956

Marketing authorisation

FDA — authorised 12 April 1956

Application: NDA010392
Marketing authorisation holder: PFIZER
Local brand name: ATARAX
Indication: TABLET — ORAL
Status: approved

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Frequently asked questions

Is Hydroxyzine HCL approved in United States?

Yes. FDA authorised it on 12 April 1956.

Who is the marketing authorisation holder for Hydroxyzine HCL in United States?

PFIZER holds the US marketing authorisation.