FDA Approves REVONTO (Dantrolene Sodium) Injectable – ANDA078378

The U.S. Food and Drug Administration (FDA) has granted approval for application number ANDA078378, authorizing the brand‑name product REVONTO. REVONTO is a dantrolene sodium injectable (generic name DANTROLENE SODIUM) supplied in a 20 mg per vial strength and intended for intravenous administration. The product is marketed by USWM, LLC and carries the package NDC 78670-003-67 (product NDC 78670-003). It is classified as a human prescription drug and is listed under the dosage form INJECTABLE. The FDA’s labeling indicates a prescription‑only marketing status. The approval timeline includes an original application approved on July 24, 2007, followed by multiple labeling supplement submissions that were approved on February 16, 2010, May 27, 2015, and most recently on November 22, 2024. These supplements reflect ongoing updates to the product’s labeling information. REVONTO is now available for prescription use in the United States, providing clinicians with an FDA‑approved intravenous formulation of dantrolene sodium for appropriate therapeutic indications.