← FDA Drug Approvals (Drugs@FDA)

QUDEXY XR

NDA · New Drug Application · Sponsor: UPSHER SMITH LABS · Approved 2014-03-11

Drug application

FDA Application #

NDA205122

Application type

New Drug Application

Brand name

QUDEXY XR

Generic name

TOPIRAMATE

Active ingredients

TOPIRAMATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

UPSHER SMITH LABS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2014-03-11

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown