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FDA ANDA · ANDA070631

VALPROIC ACID

Sponsor: CHARTWELL RX

APPLICATION
ANDA070631
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-11
LATEST ACTION
2026-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VALPROIC ACIDDiscontinued
VALPROIC ACID 250MG · CAPSULE · ORAL

Approval history

2026-03-31Labeling · Supplement 26 · standardAP
2001-02-28Labeling · Supplement 24AP
1997-12-15Manufacturing (CMC) · Supplement 19AP
1997-12-15Labeling · Supplement 23AP
1997-12-15Manufacturing (CMC) · Supplement 21AP
1997-12-15Manufacturing (CMC) · Supplement 22AP
1997-12-15Manufacturing (CMC) · Supplement 20AP
1995-05-16Manufacturing (CMC) · Supplement 17AP
1995-05-16Manufacturing (CMC) · Supplement 18AP
1993-08-31Manufacturing (CMC) · Supplement 15AP
1993-08-31Manufacturing (CMC) · Supplement 13AP
1993-08-31Manufacturing (CMC) · Supplement 16AP
1993-08-31Manufacturing (CMC) · Supplement 14AP
1993-08-31Manufacturing (CMC) · Supplement 12AP
1993-02-11Labeling · Supplement 11AP
1992-02-12Labeling · Supplement 10AP
1991-01-25Labeling · Supplement 8AP
1990-11-16Manufacturing (CMC) · Supplement 7AP
1989-10-06Manufacturing (CMC) · Supplement 6AP
1989-10-06Manufacturing (CMC) · Supplement 4AP
1989-10-06Manufacturing (CMC) · Supplement 5AP
1987-06-11OriginalAP
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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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