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. | Federal Regulations · Congress.wiki