Orange Book product · Brand (NDA)

OTOVEL

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

Brand (NDA)NDA 208251RX LAB SALVAT

Apr 29, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2016
10 yr 3 mo ago
Today
Patent 8932610 expires
Listed drug product patent expiration.
Mar 24, 2030
in 3 yr 10 mo

Active ingredient

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

Strength

EQ 0.3% BASE;0.025%

Dosage form

SOLUTION/DROPS

Route

OTIC

TE code

Not listed

Application

NDA 208251

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
8932610	Mar 24, 2030	in 3 yr 10 mo	ProductU-1578