APPLICATION
ANDA078790
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2026-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-05-28Labeling · Supplement 31 · standardAP
2026-05-28Labeling · Supplement 32 · standardAP
2026-05-28Labeling · Supplement 30 · standardAP
2024-08-13Labeling · Supplement 29 · standardAP
2023-07-31Labeling · Supplement 25 · standardAP
2023-07-31Labeling · Supplement 28 · standardAP
2023-07-31Labeling · Supplement 26 · standardAP
2023-07-31Labeling · Supplement 27 · standardAP
2020-01-14Labeling · Supplement 19 · standardAP
2020-01-14Labeling · Supplement 17 · standardAP
2020-01-14Labeling · Supplement 23 · standardAP
2020-01-14Labeling · Supplement 15 · standardAP
2020-01-14Labeling · Supplement 21 · standardAP
2020-01-14Labeling · Supplement 18 · standardAP
2020-01-14Labeling · Supplement 24 · standardAP
2020-01-14Labeling · Supplement 16 · standardAP
2020-01-14Labeling · Supplement 22 · standardAP
2020-01-14Labeling · Supplement 20 · standardAP
2014-11-08Labeling · Supplement 13 · standardAP
2014-11-08Labeling · Supplement 14 · standardAP
2014-11-08Labeling · Supplement 12 · standardAP
2010-01-20Labeling · Supplement 2AP
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.