FDA Approves Ondansetron Injectable (ANDA077473)

The U.S. Food and Drug Administration (FDA) has approved application ANDA077473 for an ondansetron injectable product marketed by Hospira, Inc. The drug is identified under the brand name ONDANSETRON and contains ondansetron hydrochloride as the active ingredient. The product is formulated as an injectable dosage form (2 mg base per mL) and is authorized for intramuscular and intravenous routes. It is classified as a prescription human drug and is listed under the product type “HUMAN PRESCRIPTION DRUG.” The approval follows an original submission (submission number 1) dated 2006‑12‑26 and a series of labeling supplements (submission numbers 7, 8, 10, 13, 14, 21) with the most recent status date recorded as 2025‑11‑18. All submissions were approved with standard review priority.