APPLICATION
ANDA078705
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-10
LATEST ACTION
2014-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-11-08Labeling · Supplement 5 · standardAP
2014-11-08Labeling · Supplement 6 · standardAP
2009-08-05Labeling · Supplement 4AP
2009-08-04Labeling · Supplement 3AP
2009-08-04Supplement · Supplement 1AP
2009-08-04Supplement · Supplement 2AP
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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