← FDA Drug Approvals (Drugs@FDA)

OXCARBAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2024-03-18

Drug application

FDA Application #

ANDA213183

Application type

Abbreviated New Drug Application (Generic)

Brand name

OXCARBAZEPINE

Generic name

OXCARBAZEPINE

Active ingredients

OXCARBAZEPINE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2024-03-18

Source

Authoritative

Drugs@FDA application overview

Machine

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