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.
Regulatory UpdatesSep 18, 2026•3 min read
FDA Approves ANDA215856 for Furosemide Injection (10 mg/mL)
The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.
Compiled by the Pharmacountry team · Source: FDA.gov
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