APPLICATION
ANDA079163
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-05
LATEST ACTION
2024-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-12-05Labeling · Supplement 32 · standardAP
2024-12-05Labeling · Supplement 30 · standardAP
2022-11-03Labeling · Supplement 23 · standardAP
2022-11-03Labeling · Supplement 28 · standardAP
2020-01-09Labeling · Supplement 17 · standardAP
2020-01-09Labeling · Supplement 8 · standardAP
2020-01-09Labeling · Supplement 11 · standardAP
2020-01-09Labeling · Supplement 18 · standardAP
2020-01-09Labeling · Supplement 16 · standardAP
2020-01-09Labeling · Supplement 20 · standardAP
2014-11-09Labeling · Supplement 6 · standardAP
2014-02-19Labeling · Supplement 3 · standardAP
2014-02-19Labeling · Supplement 1AP
2014-02-19Labeling · Supplement 5 · standardAP
2011-04-05OriginalAP
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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