APPLICATION
ANDA078523
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-17
LATEST ACTION
2026-03-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VALPROATE SODIUMPrescription
VALPROATE SODIUM EQ 100MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-03-31Labeling · Supplement 8 · standardAP
2026-03-31Labeling · Supplement 16 · standardAP
2026-03-31Labeling · Supplement 20 · standardAP
2020-04-21Labeling · Supplement 10 · standardAP
2020-04-21Labeling · Supplement 15 · standardAP
2020-04-21Labeling · Supplement 13 · standardAP
2020-04-21Labeling · Supplement 11 · standardAP
2020-04-21Labeling · Supplement 12 · standardAP
2014-12-15Labeling · Supplement 7 · standardAP
2014-12-15Labeling · Supplement 5 · standardAP
2014-12-15Labeling · Supplement 6 · standardAP
2014-12-15Labeling · Supplement 4 · standardAP
2010-02-17OriginalAP
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.