Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312
🏛 Food and Drug Administration (FDA)FDA-2026-P-4918
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