APPLICATION
ANDA090407
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-28
LATEST ACTION
2026-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2026-01-24Labeling · Supplement 17 · standardAP
2026-01-24Labeling · Supplement 15 · standardAP
2026-01-24Labeling · Supplement 18 · standardAP
2020-06-25Labeling · Supplement 13 · standardAP
2020-06-25Labeling · Supplement 9 · standardAP
2020-06-25Labeling · Supplement 11 · standardAP
2020-06-25Labeling · Supplement 14 · standardAP
2020-06-25Labeling · Supplement 12 · standardAP
2020-06-25Labeling · Supplement 8 · standardAP
2020-06-25Labeling · Supplement 10 · standardAP
2014-12-08Labeling · Supplement 6 · standardAP
2013-12-30Labeling · Supplement 5 · standardAP
2013-12-30Labeling · Supplement 2AP
2011-03-28OriginalAP
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.