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FDA approval · 2025-12-16

FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

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Summary

FDA approves ANI Pharmaceuticals' hydroxyzine hydrochloride as a generic product via an Original Application (ANDA 219648), authorizing marketing of a generic a…

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Diseases / indications

Drugs mentioned

  • HYDROXYZINE HYDROCHLORIDE (Hydroxyzine hydrochloride)

Snippet

ORIG AP for HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)