APPLICATION
ANDA078182
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2025-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2025-03-24Labeling · Supplement 26 · standardAP
2023-10-06Labeling · Supplement 25 · standardAP
2022-08-24Labeling · Supplement 22 · standardAP
2022-08-24Labeling · Supplement 20 · standardAP
2022-08-24Labeling · Supplement 19 · standardAP
2020-01-03Labeling · Supplement 13 · standardAP
2020-01-03Labeling · Supplement 16 · standardAP
2020-01-03Labeling · Supplement 14 · standardAP
2020-01-03Labeling · Supplement 17 · standardAP
2020-01-03Labeling · Supplement 15 · standardAP
2016-02-18Labeling · Supplement 11 · standardAP
2016-02-18Labeling · Supplement 9 · standardAP
2016-02-18Labeling · Supplement 7 · standardAP
2016-02-18Labeling · Supplement 10 · standardAP
2016-02-18Labeling · Supplement 8 · standardAP
2014-10-23Labeling · Supplement 4 · standardAP
2014-10-23Labeling · Supplement 2AP
2014-10-23Labeling · Supplement 6 · standardAP
2010-01-20Labeling · Supplement 1AP
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.