APPLICATION
ANDA216749
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-20
LATEST ACTION
2026-07-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG/5ML · SUSPENSION · ORAL
Approval history
2026-07-08Labeling · Supplement 5 · standardAP
2025-02-07Labeling · Supplement 2 · standardAP
2023-10-20UNKNOWN · Original · 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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