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TOVALT ODT

NDA · New Drug Application · Sponsor: BIOVAIL LABS INTL · Approved 2007-04-25

Drug application

FDA Application #

NDA021412

Application type

New Drug Application

Brand name

TOVALT ODT

Generic name

Zolpidem Tartrate

Active ingredients

ZOLPIDEM TARTRATE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Marketing status

Discontinued

Sponsor

BIOVAIL LABS INTL

First approval

2007-04-25

Source

Authoritative

Drugs@FDA application overview

Machine

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