FDA ANDA · ANDA218793
DIVALPROEX SODIUM
Sponsor: ALEMBIC
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APPLICATION
ANDA218793
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-19
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DIVALPROEX SODIUMPrescription
DIVALPROEX SODIUM EQ 125MG VALPROIC ACID · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2026-10-05Labeling · Supplement 3 · standardAP
2026-10-05Labeling · Supplement 1 · standardAP
2026-10-05Labeling · Supplement 2 · standardAP
2024-12-19UNKNOWN · Original · standardAP
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