gatifloxacin

FDA Drug Profile — ZYMAXID, Gatifloxacin

gatifloxacin is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including ZYMAXID, Gatifloxacin. Available dosage form: solution/ drops.

Drug Details

Generic Name
gatifloxacin
Brand Names
ZYMAXID, Gatifloxacin
Application Number
NDA022548
Sponsor
Allergan, Inc.
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
GATIFLOXACIN

Indications and Usage

1 INDICATIONS & USAGE Gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis* Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution 0.5 % is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae