APPLICATION
ANDA073229
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-29
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
VALPROIC ACIDPrescription
VALPROIC ACID 250MG · CAPSULE · ORAL
Approval history
2026-06-25Manufacturing (CMC) · Supplement 27 · unknownAP
2015-12-26Labeling · Supplement 13 · standardAP
2015-12-26Labeling · Supplement 12 · standardAP
2014-08-05Labeling · Supplement 11AP
2001-06-29Manufacturing (CMC) · Supplement 7AP
2001-01-18Labeling · Supplement 6AP
2000-01-27Manufacturing (CMC) · Supplement 5AP
1998-10-14Manufacturing (CMC) · Supplement 4AP
1996-11-15Manufacturing (CMC) · Supplement 2AP
1993-01-15Manufacturing (CMC) · Supplement 1AP
1991-10-29OriginalAP
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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