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FDA ANDA · ANDA076856

DANTROLENE SODIUM

Sponsor: IMPAX LABS

APPLICATION
ANDA076856
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-01
LATEST ACTION
2015-08-31
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

2015-08-31Labeling · Supplement 8 · standardAP
2005-03-01OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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