APPLICATION
ANDA040626
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-29
LATEST ACTION
2010-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMIDONEPrescription
PRIMIDONE 50MG · TABLET · ORAL
PRIMIDONEPrescription
PRIMIDONE 250MG · TABLET · ORAL
Approval history
2010-12-23Labeling · Supplement 9AP
2010-12-10Labeling · Supplement 8AP
2010-05-20Labeling · Supplement 7AP
2005-09-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.