APPLICATION
ANDA075379
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-15
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
VALPROIC ACIDPrescription
VALPROIC ACID 250MG/5ML · SYRUP · ORAL
Approval history
2024-07-08Labeling · Supplement 19 · standardAP
2024-07-08Labeling · Supplement 23 · standardAP
2020-02-21Labeling · Supplement 16 · standardAP
2020-02-21Labeling · Supplement 17 · standardAP
2020-02-21Labeling · Supplement 13 · standardAP
2020-02-21Labeling · Supplement 11 · standardAP
2015-08-13Labeling · Supplement 10 · standardAP
2015-08-13Labeling · Supplement 9 · standardAP
2015-08-13Labeling · Supplement 7AP
2010-03-15Labeling · Supplement 6AP
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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