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FDA ANDA · ANDA073178

VALPROIC ACID

Sponsor: ANI PHARMS

APPLICATION
ANDA073178
TYPE
ANDA
ORIGINAL APPROVAL
1992-08-25
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

VALPROIC ACIDPrescription
VALPROIC ACID 250MG/5ML · SYRUP · ORAL

Approval history

2026-03-31Labeling · Supplement 31 · standardAP
2020-10-30Labeling · Supplement 26 · standardAP
2020-10-30Labeling · Supplement 24 · standardAP
2020-10-30Labeling · Supplement 25 · standardAP
2010-01-06Labeling · Supplement 23AP
2006-08-22Labeling · Supplement 21AP
2002-01-23Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 16AP
2001-10-31Manufacturing (CMC) · Supplement 14AP
2001-10-31Manufacturing (CMC) · Supplement 15AP
2001-07-05Manufacturing (CMC) · Supplement 12AP
2001-07-05Manufacturing (CMC) · Supplement 11AP
2001-05-24Labeling · Supplement 9AP
2001-04-02Manufacturing (CMC) · Supplement 10AP
2001-02-26Manufacturing (CMC) · Supplement 8AP
2000-12-11Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-06-11Manufacturing (CMC) · Supplement 5AP
1997-06-02Manufacturing (CMC) · Supplement 3AP
1997-06-02Manufacturing (CMC) · Supplement 4AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1995-09-13Manufacturing (CMC) · Supplement 1AP
1992-08-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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