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Regulatory UpdatesSep 5, 2026•1 min read

FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA087592)

By the PharmaCountry team

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.

The U.S. Food and Drug Administration (FDA) has designated the Hydroxyzine Hydrochloride injectable product (product number 001) as discontinued. The product is an injectable dosage form administered via injection and contains 25 mg/mL of Hydroxyzine Hydrochloride as its active ingredient. The sponsor for this application is Smith and Nephew, and the filing is identified by application number ANDA087592. No reference drug or reference standard is associated with this product, and its marketing status is listed as discontinued.

Compiled by the PharmaCountry team · Source: FDA.gov

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