APPLICATION
ANDA070868
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-01
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 23 · standardAP
2010-01-06Labeling · Supplement 15AP
2006-12-15Labeling · Supplement 14AP
2004-03-10Labeling · Supplement 12AP
2003-03-21Labeling · Supplement 10AP
2002-05-24Labeling · Supplement 9AP
1999-05-04Manufacturing (CMC) · Supplement 7AP
1999-05-04Manufacturing (CMC) · Supplement 8AP
1993-11-24Labeling · Supplement 6AP
1989-01-11Labeling · Supplement 5AP
1987-06-15Manufacturing (CMC) · Supplement 4AP
1987-04-13Manufacturing (CMC) · Supplement 2AP
1986-12-10Manufacturing (CMC) · Supplement 1AP
1986-07-01OriginalAP
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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