APPLICATION
ANDA203730
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-29
LATEST ACTION
2020-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 250MG VALPROIC ACID · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-01-08Labeling · Supplement 8 · standardAP
2020-01-08Labeling · Supplement 4 · standardAP
2020-01-08Labeling · Supplement 7 · standardAP
2020-01-08Labeling · Supplement 10 · standardAP
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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