FDA Approves ANDA077370 for Generic Glimepiride Tablets

The U.S. Food and Drug Administration (FDA) has granted approval for application number ANDA077370, which covers generic glimepiride tablets. The product is manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc. It is classified as a human prescription drug, administered orally, and belongs to the sulfonylurea class of antidiabetic agents. Four tablet strengths are listed – 1 mg, 2 mg, 4 mg, and 8 mg – each identified by distinct product numbers and National Drug Code (NDC) identifiers. All tablets are marketed under the brand name GLIMEPIRIDE. The approval follows a series of supplemental submissions (numbers 2, 4, 9, 10, 13) that received labeling status updates between 2008 and 2025, with the original submission approved on 23 December 2005.