FDA Approves Multiple Simvastatin Tablet Labeling Submissions (ANDA 077752)

The FDA’s database for ANDA 077752 lists five oral tablet products marketed under the brand name Simvastatin. Each product is a prescription tablet with strengths of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. All are classified as non‑reference drugs and are intended for oral administration. A series of supplemental labeling submissions for these products have been approved. Submission numbers 9, 14, 16, 17, 18, 19, 20, 22, and 15 (partial data) received approval dates ranging from September 10 2008 to October 5 2015. All submissions are of type "SUPPL" with a labeling classification, and most are marked as standard review priority.