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Regulatory UpdatesSep 23, 2026•1 min read

FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)

By the PharmaCountry team

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.

The U.S. Food and Drug Administration (FDA) has updated the status of a hydroxyzine product. Hydroxyzine Hydrochloride, administered by injection, is an injectable dosage form with a strength of 25 mg/mL. The product, identified as product number 001, is marketed by sponsor SoloPak. According to the FDA database, this product is now classified as discontinued under application number ANDA 086822. No reference drug or reference standard is associated with this submission.

Compiled by the PharmaCountry team · Source: FDA.gov

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