The U.S. Food and Drug Administration (FDA) has granted approval for ANDA 087274, submitted by Watson Labs. The application covers two injectable hydroxyzine hydrochloride products:
* Product 001 – 25 mg/mL strength, injectable dosage form, route: injection.
* Product 002 – 50 mg/mL strength, injectable dosage form, route: injection.
Both products are marked as discontinued in the FDA’s database. The original submission (type: ORIG, submission number 1) received an approved status (AP) on July 28, 1981.
These approvals add to the record of hydroxyzine hydrochloride injectable offerings, though the discontinued status indicates they are no longer marketed.
規制動向2026年8月25日•1分で読めます
FDA Approves ANDA087274 for Hydroxyzine Injectable – Watson Labs
FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.
PharmaCountryチームがまとめました · 出典： FDA.gov
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