APPLICATION
ANDA076686
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-24
LATEST ACTION
2019-02-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DANTROLENE SODIUMPrescription
DANTROLENE SODIUM 50MG · CAPSULE · ORAL
DANTROLENE SODIUMPrescription
DANTROLENE SODIUM 100MG · CAPSULE · ORAL
DANTROLENE SODIUMPrescription
DANTROLENE SODIUM 25MG · CAPSULE · ORAL
Approval history
2019-02-27Manufacturing (CMC) · Supplement 4AP
2005-10-24OriginalAP
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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