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TOPAMAX

NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 1996-12-24

Drug application

FDA Application #

NDA020505

Application type

New Drug Application

Brand name

TOPAMAX

Generic name

TOPIRAMATE

Active ingredients

TOPIRAMATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PHARMS

Manufacturer

Janssen Pharmaceuticals, Inc.

First approval

1996-12-24

Source

Authoritative

Drugs@FDA application overview

Machine

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