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EDLUAR

NDA · New Drug Application · Sponsor: VIATRIS · Approved 2009-03-13

Drug application

FDA Application #

NDA021997

Application type

New Drug Application

Brand name

EDLUAR

Generic name

ZOLPIDEM TARTRATE

Active ingredients

ZOLPIDEM TARTRATE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

VIATRIS

Manufacturer

Viatris Specialty LLC

First approval

2009-03-13

Source

Authoritative

Drugs@FDA application overview

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