The U.S. Food and Drug Administration has granted approval for application ANDA 078692 submitted by Sandoz Inc. The approval covers over‑the‑counter (OTC) children’s cetirizine hydrochloride chewable tablets.
The products are marketed under the brand name “CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY” and are available in two strengths: 5 mg and 10 mg per tablet. Both are oral chewable tablets and are classified as OTC human drugs. The associated National Drug Codes (NDC) include 0781‑5283‑06, 0781‑5283‑64, 0781‑5284‑06, and 0781‑5284‑64.
The original ANDA submission (submission 1) received approval on 14 February 2008. A labeling supplement (submission 16) was later approved on 1 August 2025, updating the product labeling.
規制動向2026年9月15日•3分で読めます
FDA Approves Sandoz Children’s Cetirizine Hydrochloride Chewable Tablets (ANDA 078692)
The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.
Pharmacountryチームがまとめました · 出典： FDA.gov
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