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dantrolene sodium

FDA Drug Profile — dantrolene sodium, Dantrolene Sodium, Dantrium, RYANODEX dantrolene sodium, Revonto

Drug Details

Generic Name
dantrolene sodium
Brand Names
dantrolene sodium, Dantrolene Sodium, Dantrium, RYANODEX dantrolene sodium, Revonto
Application Number
NDA017443
Sponsor
Endo USA, Inc.
NDC Codes
19
Dosage Forms
CAPSULE, INJECTION, SUSPENSION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION
Routes
ORAL, INTRAVENOUS
Active Ingredients
DANTROLENE SODIUM

Indications and Usage

1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )