APPLICATION
ANDA077960
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-13
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
VALPROIC ACIDDiscontinued
VALPROIC ACID 250MG/5ML · SYRUP · ORAL
Approval history
2026-03-31Labeling · Supplement 28 · standardAP
2020-10-14Labeling · Supplement 21 · standardAP
2020-10-14Labeling · Supplement 26 · standardAP
2020-10-14Labeling · Supplement 24 · standardAP
2020-10-14Labeling · Supplement 22 · standardAP
2020-10-14Labeling · Supplement 20 · standardAP
2016-04-28Labeling · Supplement 19 · standardAP
2016-04-28Labeling · Supplement 17 · standardAP
2016-04-28Labeling · Supplement 15 · standardAP
2016-04-28Labeling · Supplement 18 · standardAP
2016-04-28Labeling · Supplement 16 · standardAP
2016-04-28Labeling · Supplement 14 · standardAP
2014-12-15Labeling · Supplement 13 · standardAP
2014-12-15Labeling · Supplement 9 · standardAP
2014-12-15Labeling · Supplement 11 · standardAP
2014-12-15Labeling · Supplement 12 · standardAP
2014-12-15Labeling · Supplement 10 · standardAP
2014-12-15Labeling · Supplement 6AP
2010-01-20Labeling · Supplement 4AP
2007-05-07Labeling · Supplement 1AP
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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