APPLICATION
ANDA078239
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-27
LATEST ACTION
2024-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-06-03Labeling · Supplement 33 · standardAP
2023-07-28Labeling · Supplement 26 · standardAP
2023-07-28Labeling · Supplement 32 · standardAP
2023-07-28Labeling · Supplement 29 · standardAP
2023-07-28Labeling · Supplement 27 · standardAP
2020-01-09Labeling · Supplement 23 · standardAP
2020-01-09Labeling · Supplement 21 · standardAP
2020-01-09Labeling · Supplement 18 · standardAP
2020-01-09Labeling · Supplement 24 · standardAP
2020-01-09Labeling · Supplement 22 · standardAP
2020-01-09Labeling · Supplement 19 · standardAP
2015-11-30Labeling · Supplement 17 · standardAP
2015-11-30Labeling · Supplement 15 · standardAP
2015-11-30Labeling · Supplement 11 · standardAP
2015-11-30Labeling · Supplement 14 · standardAP
2015-11-30Labeling · Supplement 12 · standardAP
2014-09-19Labeling · Supplement 9 · standardAP
2014-09-19Labeling · Supplement 5 · standardAP
2014-09-19Labeling · Supplement 3 · standardAP
2014-09-19Labeling · Supplement 8 · standardAP
2014-09-19Labeling · Supplement 6 · standardAP
2014-09-19Labeling · Supplement 4 · standardAP
2009-08-04Labeling · Supplement 1AP
2009-08-04Supplement · Supplement 2AP
2009-02-27OriginalAP
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.