FDA Approves ANDA215856 for Furosemide Injection (10 mg/mL)

The U.S. Food and Drug Administration (FDA) announced approval of ANDA215856 for a furosemide injection. The product is an intravenous, injectable dosage form containing 10 mg/mL furosemide, marketed as a prescription drug. It is manufactured by Devatis Inc. and the sponsor listed is Saba Ilac Sanayive. The approval follows a standard review; the original submission (submission number 1) received an "AP" (approved) status on April 2, 2024. The product is listed under several NDC codes (73043-022-01 through 73043-026-01). Furosemide is a loop diuretic classified under increased diuresis at the loop of Henle. The FDA labeling includes the route (intravenous) and classification as a human prescription drug.