APPLICATION
ANDA090554
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-21
LATEST ACTION
2024-06-13
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
2024-06-13Labeling · Supplement 38 · standardAP
2023-12-27Labeling · Supplement 32 · standardAP
2023-12-27Labeling · Supplement 35 · standardAP
2021-04-23Labeling · Supplement 28 · standardAP
2020-02-04Labeling · Supplement 18 · standardAP
2020-02-04Labeling · Supplement 20 · standardAP
2020-02-04Labeling · Supplement 27 · standardAP
2020-02-04Labeling · Supplement 19 · standardAP
2020-02-04Labeling · Supplement 25 · standardAP
2020-02-04Labeling · Supplement 17 · standardAP
2020-02-04Labeling · Supplement 21 · standardAP
2015-11-30Labeling · Supplement 16 · standardAP
2015-11-30Labeling · Supplement 14 · standardAP
2015-11-30Labeling · Supplement 10 · standardAP
2015-11-30Labeling · Supplement 11 · standardAP
2014-11-20Labeling · Supplement 9 · standardAP
2014-11-20Labeling · Supplement 8 · standardAP
2014-02-13Labeling · Supplement 6 · standardAP
2014-02-13Labeling · Supplement 4 · standardAP
2014-02-13Labeling · Supplement 2AP
2014-02-13Labeling · Supplement 5 · standardAP
2011-04-21OriginalAP
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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