APPLICATION
ANDA084903
TYPE
ANDA
ORIGINAL APPROVAL
1978-12-01
LATEST ACTION
2012-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRIMIDONEPrescription
PRIMIDONE 50MG · TABLET · ORAL
PRIMIDONEPrescription
PRIMIDONE 250MG · TABLET · ORAL
Approval history
2012-02-01Labeling · Supplement 26AP
2010-05-20Labeling · Supplement 23AP
2002-10-03Manufacturing (CMC) · Supplement 20AP
2001-07-13Labeling · Supplement 19AP
2001-06-25Manufacturing (CMC) · Supplement 18AP
2001-05-24Manufacturing (CMC) · Supplement 15AP
2001-05-24Labeling · Supplement 16AP
2001-05-24Manufacturing (CMC) · Supplement 17AP
2000-08-10Manufacturing (CMC) · Supplement 14AP
2000-08-04Manufacturing (CMC) · Supplement 13AP
1997-12-18Manufacturing (CMC) · Supplement 12AP
1997-03-11Manufacturing (CMC) · Supplement 11AP
1994-11-14Labeling · Supplement 10AP
1993-11-09Manufacturing (CMC) · Supplement 9AP
1993-11-09Manufacturing (CMC) · Supplement 7AP
1993-11-09Manufacturing (CMC) · Supplement 8AP
1993-11-09Labeling · Supplement 6AP
1991-06-28Labeling · Supplement 5AP
1990-03-21Labeling · Supplement 3AP
1978-12-01OriginalAP
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.