APPLICATION
ANDA090062
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-17
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-10-11Labeling · Supplement 9 · standardAP
2024-10-11Labeling · Supplement 16 · standardAP
2024-10-11Labeling · Supplement 7 · standardAP
2024-10-11Labeling · Supplement 12 · standardAP
2024-10-11Labeling · Supplement 10 · standardAP
2024-10-11Labeling · Supplement 17 · standardAP
2024-10-11Labeling · Supplement 8 · standardAP
2024-10-11Labeling · Supplement 15 · standardAP
2024-10-11Labeling · Supplement 13 · standardAP
2024-10-11Labeling · Supplement 11 · standardAP
2014-11-08Labeling · Supplement 5 · standardAP
2014-11-08Labeling · Supplement 4 · standardAP
2010-01-20Labeling · Supplement 2AP
2009-03-17OriginalAP
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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