APPLICATION
ANDA209286
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-18
LATEST ACTION
2026-06-11
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
2026-06-11Labeling · Supplement 20 · standardAP
2026-06-11Labeling · Supplement 19 · standardAP
2026-06-11Labeling · Supplement 17 · standardAP
2024-07-10Labeling · Supplement 11 · standardAP
2023-07-10Labeling · Supplement 8 · standardAP
2022-11-16Labeling · Supplement 6 · standardAP
2022-11-16Labeling · Supplement 4 · standardAP
2022-11-16Labeling · Supplement 3 · standardAP
2019-10-18UNKNOWN · Original · standardAP
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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