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FDA ANDA · ANDA207717

OXCARBAZEPINE

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA207717
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-05
LATEST ACTION
2026-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OXCARBAZEPINEPrescription
OXCARBAZEPINE 300MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 600MG · TABLET · ORAL
OXCARBAZEPINEPrescription
OXCARBAZEPINE 150MG · TABLET · ORAL

Approval history

2026-05-15Labeling · Supplement 1 · standardAP
2024-03-05UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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