APPLICATION
ANDA077615
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2026-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-05-18Labeling · Supplement 24 · standardAP
2026-05-18Labeling · Supplement 25 · standardAP
2026-05-18Labeling · Supplement 23 · standardAP
2024-06-03Labeling · Supplement 22 · standardAP
2023-07-31Labeling · Supplement 21 · standardAP
2023-07-31Labeling · Supplement 18 · standardAP
2023-07-31Labeling · Supplement 20 · standardAP
2023-07-31Labeling · Supplement 19 · standardAP
2019-11-27Labeling · Supplement 13 · standardAP
2019-11-27Labeling · Supplement 11 · standardAP
2019-11-27Labeling · Supplement 16 · standardAP
2019-11-27Labeling · Supplement 14 · standardAP
2019-11-27Labeling · Supplement 12 · standardAP
2019-11-27Labeling · Supplement 17 · standardAP
2019-11-27Labeling · Supplement 15 · standardAP
2015-05-22Labeling · Supplement 9 · standardAP
2015-05-22Labeling · Supplement 7 · standardAP
2015-05-22Labeling · Supplement 10 · standardAP
2015-05-22Labeling · Supplement 8 · standardAP
2014-09-16Labeling · Supplement 4 · standardAP
2014-09-16Labeling · Supplement 5 · standardAP
2014-09-16Labeling · Supplement 6 · standardAP
2011-01-21Labeling · Supplement 3AP
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.