APPLICATION
ANDA078791
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-06
LATEST ACTION
2020-01-21
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
2020-01-21Labeling · Supplement 18 · standardAP
2020-01-21Labeling · Supplement 16 · standardAP
2020-01-21Labeling · Supplement 14 · standardAP
2020-01-21Labeling · Supplement 20 · standardAP
2020-01-21Labeling · Supplement 13 · standardAP
2016-02-16Labeling · Supplement 9 · standardAP
2009-08-04Labeling · Supplement 2AP
2009-08-04Supplement · Supplement 1AP
2009-05-06OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.