General MedicationsNASALStandard

KOVANAZE

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Standard Dose

0.1MG/SPRAY;6MG/SPRAY

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview KOVANAZE is listed in Drugs@FDA under application 208032 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - 0.1MG/SPRAY;6MG/SPRAY Sponsor ST RENATUS Submission history Latest submission status date: 2018-11-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview KOVANAZE is listed in Drugs@FDA under application 208032 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - 0.1MG/SPRAY;6MG/SPRAY Sponsor ST RENATUS Submission history Latest submission status date: 2018-11-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.