APPLICATION
ANDA077567
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-29
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-12Labeling · Supplement 39 · standardAP
2025-09-02Labeling · Supplement 38 · standardAP
2025-09-02Labeling · Supplement 36 · standardAP
2025-09-02Labeling · Supplement 37 · standardAP
2023-10-23Labeling · Supplement 28 · standardAP
2023-10-23Labeling · Supplement 34 · standardAP
2023-10-23Labeling · Supplement 32 · standardAP
2023-10-23Labeling · Supplement 29 · standardAP
2020-01-03Labeling · Supplement 19 · standardAP
2020-01-03Labeling · Supplement 17 · standardAP
2020-01-03Labeling · Supplement 26 · standardAP
2020-01-03Labeling · Supplement 24 · standardAP
2020-01-03Labeling · Supplement 14 · standardAP
2020-01-03Labeling · Supplement 20 · standardAP
2015-09-22Labeling · Supplement 13 · standardAP
2015-09-22Labeling · Supplement 11 · standardAP
2015-09-22Labeling · Supplement 12 · standardAP
2014-09-13Labeling · Supplement 8 · standardAP
2014-09-13Labeling · Supplement 10 · standardAP
2014-09-13Labeling · Supplement 9 · standardAP
2010-09-10Labeling · Supplement 5AP
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.