APPLICATION
ANDA090210
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-30
LATEST ACTION
2014-11-26
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
2014-11-26Labeling · Supplement 8 · standardAP
2014-11-26Labeling · Supplement 6 · standardAP
2014-11-26Labeling · Supplement 2AP
2014-11-26Labeling · Supplement 10 · standardAP
2014-11-26Labeling · Supplement 9 · standardAP
2014-11-26Labeling · Supplement 7 · standardAP
2009-11-30OriginalAP
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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