APPLICATION
ANDA078853
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-25
LATEST ACTION
2023-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-11-22Labeling · Supplement 17 · standardAP
2023-11-22Labeling · Supplement 15 · standardAP
2023-01-11Labeling · Supplement 14 · standardAP
2022-01-07Labeling · Supplement 13 · standardAP
2022-01-07Labeling · Supplement 11 · standardAP
2022-01-07Labeling · Supplement 9 · standardAP
2022-01-07Labeling · Supplement 12 · standardAP
2022-01-07Labeling · Supplement 10 · standardAP
2022-01-07Labeling · Supplement 8 · standardAP
2014-03-18Labeling · Supplement 6 · standardAP
2014-03-18Labeling · Supplement 7 · standardAP
2014-03-18Labeling · Supplement 5 · standardAP
2010-01-20Labeling · Supplement 1AP
2008-11-25OriginalAP
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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