APPLICATION
ANDA202419
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-02
LATEST ACTION
2026-06-15
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
2026-06-15Labeling · Supplement 32 · standardAP
2026-06-15Labeling · Supplement 33 · standardAP
2025-03-27Labeling · Supplement 31 · standardAP
2024-06-03Labeling · Supplement 29 · standardAP
2023-07-11Labeling · Supplement 27 · standardAP
2022-12-27Labeling · Supplement 22 · standardAP
2022-12-27Labeling · Supplement 25 · standardAP
2020-02-10Labeling · Supplement 16 · standardAP
2020-02-10Labeling · Supplement 14 · standardAP
2020-02-10Labeling · Supplement 20 · standardAP
2020-02-10Labeling · Supplement 10 · standardAP
2020-02-10Labeling · Supplement 17 · standardAP
2020-02-10Labeling · Supplement 9 · standardAP
2020-02-10Labeling · Supplement 21 · standardAP
2020-02-10Labeling · Supplement 13 · standardAP
2020-02-10Labeling · Supplement 11 · standardAP
2015-09-23Labeling · Supplement 4 · standardAP
2015-09-23Labeling · Supplement 7 · standardAP
2015-09-23Labeling · Supplement 5 · standardAP
2014-11-20Labeling · Supplement 2 · standardAP
2014-11-20Labeling · Supplement 3 · standardAP
2014-06-02UNKNOWN · OriginalAP
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.
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