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KOVANAZE

NDA · New Drug Application · Sponsor: ST RENATUS · Approved 2016-06-29

Drug application

FDA Application #

NDA208032

Application type

New Drug Application

Brand name

KOVANAZE

Generic name

Oxymetazoline Hydrochloride

Active ingredients

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Dosage form

SPRAY, METERED

Route

NASAL

Marketing status

Prescription

Sponsor

ST RENATUS

First approval

2016-06-29

Source

Authoritative

Drugs@FDA application overview

Machine

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