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OXTELLAR XR

NDA · New Drug Application · Sponsor: SUPERNUS PHARMS · Approved 2012-10-19

Drug application

FDA Application #

NDA202810

Application type

New Drug Application

Brand name

OXTELLAR XR

Generic name

OXCARBAZEPINE

Active ingredients

OXCARBAZEPINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

SUPERNUS PHARMS

Manufacturer

Supernus Pharmaceuticals, Inc.

First approval

2012-10-19

Source

Authoritative

Drugs@FDA application overview

Machine

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