Requests that FDA declare that Ezetimibe and Simvastatin Tablets, 10 mg/15 mg & 10 mg/30 mg, are suitable for submission as ANDA. Petition used Organon LLC’s VYTORIN (ezetimibe and simvastatin) Tablets, approved for prescription under (NDA) 021687 in 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, & 10 mg/80 mg strengths. Petitioner seeks new strengths 10 mg/15 mg and 10 mg/30 mg for prescription use.
🏛 Food and Drug Administration (FDA)FDA-2026-P-5995
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