ANDA 76856, held by Impax Labs. Dantrolene Sodium.
As of Nov 15, 2026, ANDA 76856 (Dantrolene Sodium), held by Impax Labs, was first approved by FDA on Mar 1, 2005, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE In Chronic Spasticity Dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 1, 2005 | Original application | Approved | None posted |
| Dantrolene Sodium25MG · capsule;oral | Dantrolene Sodium | Rx |
| Dantrolene Sodium50MG · capsule;oral | Dantrolene Sodium | Rx |
| Dantrolene Sodium100MG · capsule;oral | Dantrolene Sodium | Rx |
| Aug 31, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 1, 2005 | 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
