Manages fulminant hypermetabolism of skeletal muscle characteristic of malignant…. ANDA 204762, held by Hikma. Dantrolene Sodium.
As of Nov 15, 2026, ANDA 204762 (Dantrolene Sodium), held by Hikma, was first approved by FDA on Jun 19, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE 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. Dantrolene Sodium for Injection 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 |
|---|---|---|---|
| Jun 19, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dantrolene Sodium20MG/VIAL · injectable;injection | Dantrolene Sodium | Rx |
| Apr 18, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 19, 2017 | Original application | Approved | None posted |
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
