FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)

The U.S. Food and Drug Administration (FDA) has updated the status of a hydroxyzine product. Hydroxyzine Hydrochloride, presented as an injectable dosage form (50 mg/mL), is identified under product number 001. The product is marketed by PharmaFair and is recorded with the application number ANDA089107. According to the FDA database, the marketing status of this injectable is "Discontinued." No reference drug or reference standard is associated with this submission. Stakeholders should note the discontinuation when considering supply, formulation, or therapeutic alternatives involving hydroxyzine hydrochloride injection.