Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
04/29/2016
Trade Name:
Otovel Otic Solution
Generic Name or Proper Name (*):
ciprofloxacin and fluocinolone acetonide
Indications Studied:
Treatment of acute otitis media with tympanostomy tubes in pediatric patients 6 months and older
Label Changes Summary:
* Approved for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients aged 6 months and older, * Information on dosing, and clinical trials. * New drug.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Laboratorios SALVAT, S.A.
NNPS:
FALSE
Therapeutic Category:
antibiotic/anti-inflammatory
-
-