ANDA 76686, held by Elite Labs Inc. Dantrolene Sodium.
As of Nov 15, 2026, ANDA 76686 (Dantrolene Sodium), held by Elite Labs Inc, was first approved by FDA on Oct 24, 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 is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 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 |
| Feb 27, 2019 | Supplement 4Manufacturing | Approved | None posted |
| Oct 24, 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
