NDA 17443, held by Ph Health. Dantrolene Sodium.
As of Nov 13, 2026, NDA 17443 (Dantrium), held by Ph Health, was first approved by FDA on Jan 15, 1974, with 40 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium is 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 is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 1974 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dantrium25MG · capsule;oral | Dantrolene Sodium | RxReference drug |
| Dantrium100MG · capsule;oral | Dantrolene Sodium | RxReference drug |
| Dantrium50MG · capsule;oral | Dantrolene Sodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2015 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Mar 11, 2014 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Jul 17, 2012 | Supplement 49Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 48Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 46Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 43Labeling · Standard review | Approved | |
| Oct 30, 1997 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1997 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Sep 18, 1996 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Jan 24, 1992 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| May 20, 1991 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1990 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Jun 29, 1989 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Jul 23, 1985 | Supplement 36Labeling | Approved | None posted |
| May 20, 1985 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Nov 18, 1983 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| May 16, 1983 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| May 16, 1983 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| May 16, 1983 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| May 16, 1983 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| May 16, 1983 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Sep 29, 1982 | Supplement 25Labeling | Approved | None posted |
| Oct 9, 1981 | Supplement 24Labeling | Approved | None posted |
| Mar 18, 1981 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1979 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Aug 15, 1979 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Aug 15, 1979 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jul 5, 1979 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Oct 25, 1977 | Supplement 16Labeling | Approved | None posted |
| Jun 27, 1977 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1977 | Supplement 15Labeling | Approved | None posted |
| Jun 15, 1977 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 16, 1976 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| May 12, 1976 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| May 12, 1976 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1975 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Nov 19, 1975 | Supplement 6Labeling | Approved | None posted |
| Oct 10, 1975 | Supplement 9Labeling | Approved | None posted |
| Jul 15, 1975 | Supplement 8Labeling | Approved | None posted |
| Feb 26, 1975 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jan 15, 1974 | Original applicationNew molecular entity · Priority review | 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
