APPLICATION
ANDA075782
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-22
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
VALPROIC ACIDPrescription
VALPROIC ACID 250MG/5ML · SYRUP · ORAL
Approval history
2026-03-31Labeling · Supplement 13 · standardAP
2025-02-03Labeling · Supplement 12 · standardAP
2020-04-21Labeling · Supplement 8 · standardAP
2020-04-21Labeling · Supplement 4 · standardAP
2020-04-21Labeling · Supplement 9 · standardAP
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.