APPLICATION
ANDA083551
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-07
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMIDONEPrescription
PRIMIDONE 250MG · TABLET · ORAL
Approval history
2025-09-23Labeling · Supplement 51 · standardAP
2011-03-30Labeling · Supplement 42AP
2010-05-20Labeling · Supplement 40AP
2001-04-25Manufacturing (CMC) · Supplement 24AP
2000-07-03Manufacturing (CMC) · Supplement 23AP
1992-05-01Labeling · Supplement 21AP
1992-02-27Labeling · Supplement 20AP
1991-08-07Manufacturing (CMC) · Supplement 18AP
1991-01-28Manufacturing (CMC) · Supplement 19AP
1990-06-29Manufacturing (CMC) · Supplement 17AP
1988-06-29Manufacturing (CMC) · Supplement 15AP
1988-06-29Manufacturing (CMC) · Supplement 16AP
1988-06-29Manufacturing (CMC) · Supplement 14AP
1985-06-19Manufacturing (CMC) · Supplement 12AP
1985-06-19Manufacturing (CMC) · Supplement 13AP
1985-03-19Manufacturing (CMC) · Supplement 11AP
1979-02-07OriginalAP
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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