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FDA NDA · NDA208032

KOVANAZE

Sponsor: ST RENATUS

APPLICATION
NDA208032
TYPE
NDA
ORIGINAL APPROVAL
2016-06-29
LATEST ACTION
2018-11-02
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

KOVANAZE · ReferencePrescription
OXYMETAZOLINE HYDROCHLORIDE 0.1MG/SPRAY, TETRACAINE HYDROCHLORIDE 6MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2018-11-02Labeling · Supplement 4 · standard — Label ↗AP
2016-06-29Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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