APPLICATION
ANDA077296
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-31
LATEST ACTION
2023-07-31
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
2023-07-31Labeling · Supplement 11 · standardAP
2023-07-31Labeling · Supplement 9 · standardAP
2023-07-31Labeling · Supplement 12 · standardAP
2023-07-31Labeling · Supplement 10 · standardAP
2020-01-09Labeling · Supplement 8 · standardAP
2020-01-09Labeling · Supplement 7 · standardAP
2018-03-08Labeling · Supplement 4 · standardAP
2018-03-08Labeling · Supplement 5 · standardAP
2014-01-06Manufacturing (CMC) · Supplement 2AP
2011-01-21Labeling · Supplement 3AP
2008-07-31OriginalAP
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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