FDA ANDA · ANDA218278
OXCARBAZEPINE
Sponsor: BIOCON PHARMA
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APPLICATION
ANDA218278
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-01
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG/5ML · SUSPENSION · ORAL
Approval history
2026-10-08Labeling · Supplement 2 · standardAP
2025-02-28Labeling · Supplement 1 · standardAP
2024-03-01UNKNOWN · Original · standardAP
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