APPLICATION
ANDA040866
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2012-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMIDONEPrescription
PRIMIDONE 50MG · TABLET · ORAL
PRIMIDONEPrescription
PRIMIDONE 250MG · TABLET · ORAL
Approval history
2012-10-19Labeling · Supplement 9AP
2011-03-29Labeling · Supplement 8AP
2010-11-30Labeling · Supplement 7AP
2010-05-20Labeling · Supplement 6AP
2009-04-21Labeling · Supplement 1AP
2008-04-23OriginalAP
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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