Manages fulminant hypermetabolism of skeletal muscle characteristic of malignant…. ANDA 78378, held by Uswm. Dantrolene Sodium.
As of Nov 15, 2026, ANDA 78378 (Revonto), held by Uswm, was first approved by FDA on Jul 24, 2007, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Revonto20MG/VIAL · injectable;injection | Dantrolene Sodium | Rx |
| Nov 22, 2024 | Supplement 21Labeling · Standard review | Approved | None posted |
| May 27, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 16, 2010 | Supplement 4Labeling | Approved | None posted |
| Feb 16, 2010 | Supplement 5Labeling | Approved | None posted |
| Feb 16, 2010 | Supplement 6Labeling | Approved | None posted |
| Jul 24, 2007 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
