APPLICATION
ANDA218366
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-23
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMIDONEPrescription
PRIMIDONE 250MG · TABLET · ORAL
PRIMIDONEPrescription
PRIMIDONE 50MG · TABLET · ORAL
Approval history
2025-03-21Labeling · Supplement 1 · standardAP
2024-01-23UNKNOWN · Original · standardAP
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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