APPLICATION
ANDA078755
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2014-11-08
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
2014-11-08Labeling · Supplement 3 · standardAP
2011-01-21Labeling · Supplement 1AP
2008-07-29OriginalAP
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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