FDA ANDA · ANDA078700
DIVALPROEX SODIUM
Sponsor: COSETTE PHARMS NC
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APPLICATION
ANDA078700
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-03
LATEST ACTION
2026-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-02Labeling · Supplement 7 · standardAP
2026-10-02Labeling · Supplement 5 · standardAP
2026-10-02Labeling · Supplement 6 · standardAP
2011-09-27Labeling · Supplement 1AP
2009-08-03OriginalAP
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