APPLICATION
ANDA078445
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-26
LATEST ACTION
2016-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2016-02-28Labeling · Supplement 16 · standardAP
2016-02-28Labeling · Supplement 14 · standardAP
2016-02-28Labeling · Supplement 15 · standardAP
2014-10-26Labeling · Supplement 9 · standardAP
2014-10-26Labeling · Supplement 12 · standardAP
2014-10-26Labeling · Supplement 10 · standardAP
2014-10-26Labeling · Supplement 5AP
2009-08-04Supplement · Supplement 2AP
2009-08-04Supplement · Supplement 3AP
2009-08-04Labeling · Supplement 4AP
2009-02-26OriginalAP
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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