APPLICATION
NDA017443
TYPE
NDA
ORIGINAL APPROVAL
1974-01-15
LATEST ACTION
2015-07-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DANTRIUM · ReferencePrescription
DANTROLENE SODIUM 50MG · CAPSULE · ORAL
DANTRIUM · ReferencePrescription
DANTROLENE SODIUM 25MG · CAPSULE · ORAL
DANTRIUM · ReferencePrescription
DANTROLENE SODIUM 100MG · CAPSULE · ORAL
Approval history
2015-07-08Manufacturing (CMC) · Supplement 65 · priorityAP
2014-03-11Manufacturing (CMC) · Supplement 64 · priorityAP
1997-10-30Manufacturing (CMC) · Supplement 47 · priorityAP
1997-03-14Manufacturing (CMC) · Supplement 45 · priorityAP
1996-09-18Manufacturing (CMC) · Supplement 44 · priorityAP
1992-01-24Manufacturing (CMC) · Supplement 41 · priorityAP
1991-05-20Manufacturing (CMC) · Supplement 40 · priorityAP
1990-02-14Manufacturing (CMC) · Supplement 39 · priorityAP
1989-06-29Manufacturing (CMC) · Supplement 38 · priorityAP
1985-07-23Labeling · Supplement 36AP
1985-05-20Manufacturing (CMC) · Supplement 35 · priorityAP
1983-11-18Manufacturing (CMC) · Supplement 28 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 30 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 29 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 33 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 31 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 32 · priorityAP
1982-09-29Labeling · Supplement 25AP
1981-10-09Labeling · Supplement 24AP
1981-03-18Manufacturing (CMC) · Supplement 23 · priorityAP
1979-09-17Manufacturing (CMC) · Supplement 22 · priorityAP
1979-08-15Manufacturing (CMC) · Supplement 20 · priorityAP
1979-08-15Manufacturing (CMC) · Supplement 21 · priorityAP
1979-07-05Manufacturing (CMC) · Supplement 19 · priorityAP
1977-10-25Labeling · Supplement 16AP
1977-06-27Manufacturing (CMC) · Supplement 17 · priorityAP
1977-06-15Labeling · Supplement 15AP
1977-06-15Manufacturing (CMC) · Supplement 13 · priorityAP
1976-07-16Manufacturing (CMC) · Supplement 11 · priorityAP
1976-05-12Manufacturing (CMC) · Supplement 12 · priorityAP
1976-05-12Manufacturing (CMC) · Supplement 10 · priorityAP
1975-11-20Manufacturing (CMC) · Supplement 7 · priorityAP
1975-11-19Labeling · Supplement 6AP
1975-10-10Labeling · Supplement 9AP
1975-07-15Labeling · Supplement 8AP
1975-02-26Manufacturing (CMC) · Supplement 2 · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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