← FDA Drug Approvals (Drugs@FDA)

OXCARBAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA LABS PVT · Approved 2026-04-29

Drug application

FDA Application #

ANDA218341

Application type

Abbreviated New Drug Application (Generic)

Brand name

OXCARBAZEPINE

Generic name

OXCARBAZEPINE

Active ingredients

OXCARBAZEPINE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

UMEDICA LABS PVT

Manufacturer

Umedica Laboratories USA Inc.

First approval

2026-04-29

Source

Authoritative

Drugs@FDA application overview

Machine

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