APPLICATION
ANDA040862
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-03
LATEST ACTION
2011-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRIMIDONEDiscontinued
PRIMIDONE 50MG · TABLET · ORAL
PRIMIDONEDiscontinued
PRIMIDONE 250MG · TABLET · ORAL
Approval history
2011-11-17REMS · Supplement 4AP
2011-09-20Labeling · Supplement 2AP
2010-11-30Labeling · Supplement 1AP
2008-10-03OriginalAP
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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