APPLICATION
ANDA214462
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-15
LATEST ACTION
2026-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-01-29Labeling · Supplement 4 · standardAP
2026-01-29Labeling · Supplement 3 · standardAP
2024-07-10Labeling · Supplement 2 · standardAP
2023-06-08Labeling · Supplement 1 · standardAP
2021-03-15UNKNOWN · 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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