Orange Book product · Brand (NDA)

KOVANAZE

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Brand (NDA)NDA 208032RX ST RENATUS

Jun 29, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 29, 2016
10 yr 1 mo ago
Today
Patent 8580282 expires
Listed drug product patent expiration.
Apr 02, 2030
in 3 yr 10 mo
Patent 9308191 expires
Listed drug product patent expiration.
Apr 02, 2030
in 3 yr 10 mo

Active ingredient

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Strength

0.1MG/SPRAY;6MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 208032

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8580282	Apr 02, 2030	in 3 yr 10 mo	ProductU-1876
9308191	Apr 02, 2030	in 3 yr 10 mo	ProductU-1876